<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02248974</url>
  </required_header>
  <id_info>
    <org_study_id>H-34286</org_study_id>
    <secondary_id>CDR-1306-01769</secondary_id>
    <nct_id>NCT02248974</nct_id>
  </id_info>
  <brief_title>Development &amp; Testing of a Decision Aid for LVAD Placement</brief_title>
  <acronym>VADDA</acronym>
  <official_title>Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Methodist Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>INTEGRIS Baptist Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Texas Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aurora Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ochsner Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to develop a patient-centered decision aid for decision-making&#xD;
      about end-stage heart failure treatment. This study seeks to create a decision aid that&#xD;
      presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular&#xD;
      Assist Device (LVAD) placement to help patients make values-based decisions about placement.&#xD;
      The investigators propose a mixed methods design involving a literature search of clinical&#xD;
      evidence, semi-structured patient interviews, and quantitative data from a multi-site trial&#xD;
      of patients receiving the decision aid compared to patients not receiving the aid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Left Ventricular Assist Device (LVAD) Knowledge Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At Baseline, this scale measures LVAD knowledge before patients receive any formal education (from their LVAD coordinators and/or physicians) about LVAD therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left Ventricular Assist Device (LVAD) Knowledge Scale</measure>
    <time_frame>1-Week Follow-up</time_frame>
    <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 week following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left Ventricular Assist Device (LVAD) Knowledge Scale</measure>
    <time_frame>1-Month Follow-up</time_frame>
    <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 month following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Measures the construct of decisional conflict, using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>1 Week Follow-up</time_frame>
    <description>Measures the construct of decisional conflict (at this timepoint, 1 week after baseline), using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>collaboRATE-Shared Decision Making</measure>
    <time_frame>1 Week Follow-up</time_frame>
    <description>Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 week after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>collaboRATE-Shared Decision Making</measure>
    <time_frame>1 Month Follow-up</time_frame>
    <description>Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Decision Making Process</measure>
    <time_frame>1 Month Follow-up</time_frame>
    <description>Measures a participant's satisfaction with their decision of treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater satisfaction with the decision making process, a more positive outcome), with scores ranging from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ottawa Decision Regret Scale</measure>
    <time_frame>1 Month Follow-up</time_frame>
    <description>The 'Decision Regret Scale' measures &quot;distress or remorse after a (health care) decision.&quot; In a short introductory statement, respondents should be asked to reflect on a specific past decision, and then asked to indicate the extent to which they agree or disagree with the statements in the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. Regret is measured at a point in time when the respondent can reflect on the effects of the decision. Items 2 and 4 should be reverse coded so that, for each item, a higher number will indicate more regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Life Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Life Scale</measure>
    <time_frame>1 Month Follow-up</time_frame>
    <description>Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparedness for Decision-Making Scale</measure>
    <time_frame>1 Week Follow-up</time_frame>
    <description>The Preparedness for Decision-Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision (treatment/diagnostic/screening, etc.). Items can be summed and scored (sum the 10 items and divide by 10). B) Scores are converted to a 0-100 scale by: subtracting 1 from the summed score in part a) and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision-making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.</measure>
    <time_frame>1 Day Follow-up</time_frame>
    <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shared Decision-Making (SDM-9)</measure>
    <time_frame>1-Week Follow-Up</time_frame>
    <description>A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shared Decision-Making (SDM-9)</measure>
    <time_frame>1-Month Follow-Up</time_frame>
    <description>A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up</measure>
    <time_frame>1-Month Follow-Up</time_frame>
    <description>Measure of the degree (percentage) of match in patient-reported preferences related to control over treatment decision at Baseline and 1-Month. This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points. The results are reported as the number of participants with a 1:1 &quot;match&quot; in preferences at both time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect</measure>
    <time_frame>1-Week Follow-Up</time_frame>
    <description>Percentage of patients reporting that their ability to envision life with an LVAD was &quot;Somewhat Easy&quot; or &quot;Easy.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect</measure>
    <time_frame>1-Month Follow-Up</time_frame>
    <description>Number and percentage of patients reporting that their ability to envision life with an LVAD was &quot;Difficult&quot; or that they had &quot;No idea.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number &amp; Percentage of Participants Who Perceived a Strong Likelihood of Transplant</measure>
    <time_frame>1-Week Follow-Up</time_frame>
    <description>Measures the number and percentage of participants who perceived a strong likelihood of transplant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant</measure>
    <time_frame>1-Month Follow-Up</time_frame>
    <description>Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' Perceived Survival Estimate in Number of Years After LVAD Implant</measure>
    <time_frame>1-Week Follow-Up</time_frame>
    <description>Patient-reported estimate of number of years the average patient is able to live after LVAD implant. Participants wrote in a number in a blank space, and numbers were recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Life</measure>
    <time_frame>1-Month Follow-Up</time_frame>
    <description>Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life -- Health Rating</measure>
    <time_frame>Baseline</time_frame>
    <description>Responses to the question: &quot;On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life -- Health Rating</measure>
    <time_frame>1-Month Follow-Up</time_frame>
    <description>Responses to the question: &quot;On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preferred Treatment: Number of Patients Predicting They Will Choose LVAD</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of patients forecasting that they will choose LVAD treatment (before their actual decision), measured using a binary score representing yes (1) or no (0) indicating whether a patient predicted they would choose LVAD as a preferred treatment for their advanced heart failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Whose Preferred Treatment Was LVAD</measure>
    <time_frame>1-Week Follow-Up</time_frame>
    <description>Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Whose Preferred Treatment Was LVAD</measure>
    <time_frame>1-Month Follow-Up</time_frame>
    <description>Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Percentage of Patients Who Filled Out an Advanced Directive</measure>
    <time_frame>1-Month Follow-Up</time_frame>
    <description>Number and percentage of patients who filled out an Advanced Directive, using a binary measure indicating whether a respondent has filled out an advanced directive (1) or not (0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.</measure>
    <time_frame>1 Day Follow-up</time_frame>
    <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability and Acceptability: Learned Something New That I Didn't Know Before.</measure>
    <time_frame>1 Day Follow-up</time_frame>
    <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability and Acceptability: Would Recommend to Others.</measure>
    <time_frame>1 Day Follow-up</time_frame>
    <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability and Acceptability: Held my Interest.</measure>
    <time_frame>1 Day Follow-up</time_frame>
    <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability and Acceptability: Helps Someone Make an Informed Decision.</measure>
    <time_frame>1 Day Follow-up</time_frame>
    <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.</measure>
    <time_frame>1 Day Follow-up</time_frame>
    <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' Control Preferences Over Treatment Decision-Making</measure>
    <time_frame>Baseline</time_frame>
    <description>This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' Control Preferences Over Treatment Decision-Making</measure>
    <time_frame>1-Month</time_frame>
    <description>This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points (baseline and 1-month follow-up).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>End-Stage Heart Failure</condition>
  <condition>Bridge-to-Transplant LVAD Placement (BTT)</condition>
  <condition>Destination Therapy LVAD Placement (DT)</condition>
  <condition>Refusal of LVAD Placement (Decliners)</condition>
  <condition>LVAD Caregivers</condition>
  <arm_group>
    <arm_group_label>LVAD Decision Aid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No LVAD Decision Aid</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LVAD Decision Aid</intervention_name>
    <description>Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
    <arm_group_label>LVAD Decision Aid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  LVAD Candidates (NYHA Class III and IV patients with an acceptable surgical&#xD;
             risk/benefit ratio for LVAD implantation and with good psychosocial support, coping&#xD;
             mechanisms, and financial resources, as determined by &quot;clearance&quot; from the transplant&#xD;
             social worker)&#xD;
&#xD;
          -  LVAD Patients&#xD;
&#xD;
          -  LVAD Decliners&#xD;
&#xD;
          -  LVAD Caregivers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects who lack the capacity to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Blumenthal-Barby, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristin M Kostick, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ochsner Health System</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INTEGRIS Baptist Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Health Care</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.lvaddecisionaid.com</url>
    <description>Project Website</description>
  </link>
  <reference>
    <citation>Bruce CR, Delgado E, Kostick K, Grogan S, Ashrith G, Trachtenberg B, Estep JD, Bhimaraj A, Pham L, Blumenthal-Barby JS. Ventricular assist devices: a review of psychosocial risk factors and their impact on outcomes. J Card Fail. 2014 Dec;20(12):996-1003. doi: 10.1016/j.cardfail.2014.09.006. Epub 2014 Sep 17.</citation>
    <PMID>25239054</PMID>
  </reference>
  <reference>
    <citation>Blumenthal-Barby, J. S., Kristin M. Kostick, Estevan D. Delgado, Robert J. Volk, Holland M. Kaplan, L. A. Wilhelms, Sheryl A. McCurdy, Jerry D. Estep, Matthias Loebe, and Courtenay R. Bruce.</citation>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>April 3, 2017</results_first_submitted>
  <results_first_submitted_qc>February 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 31, 2019</results_first_posted>
  <last_update_submitted>February 14, 2019</last_update_submitted>
  <last_update_submitted_qc>February 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Jennifer Blumenthal-Barby</investigator_full_name>
    <investigator_title>Assistant Professor of Philosophy/Bioethics</investigator_title>
  </responsible_party>
  <keyword>End-Stage Heart Failure</keyword>
  <keyword>Left Ventricular Assist Device</keyword>
  <keyword>Decision Aid</keyword>
  <keyword>Medical Decision-Making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>We enrolled a total of 98 participants. This number is consistent between the Protocol Section and the Participant Flow Module.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LVAD Decision Aid</title>
          <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
        </group>
        <group group_id="P2">
          <title>No LVAD Decision Aid</title>
          <description>The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>1-Day Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="0">&quot;No DA&quot; group did not receive 1-Day Follow-up survey.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="0">&quot;No DA&quot; group did not receive 1-Day Follow-up survey.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled in another study</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>1-Week Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Became ineligible for LVAD</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled in another study</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transferred to another facility</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Cognitive Difficulty</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Excluded because of age</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliant with terms of participation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Timing: implanted before survey</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>1-Month Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LVAD Decision Aid</title>
          <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
        </group>
        <group group_id="B2">
          <title>No LVAD Decision Aid</title>
          <description>The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="47"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="98"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.61" spread="14.03"/>
                    <measurement group_id="B2" value="59.94" spread="9.67"/>
                    <measurement group_id="B3" value="59.77" spread="12.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Caregiver</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 Caregivers</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Caregiver</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 Caregivers</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=3 Caregivers</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;$15,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$15,000-$30,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$30,000-$60,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$60,000-$100,00</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;$100,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Separated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Widowed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Single/never married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Common law</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>8th grade or less</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school degree/GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4-yr college graduate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing data</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Private</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Public</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Private and Public</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Left Ventricular Assist Device (LVAD) Knowledge Scale</title>
        <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At Baseline, this scale measures LVAD knowledge before patients receive any formal education (from their LVAD coordinators and/or physicians) about LVAD therapy.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Assist Device (LVAD) Knowledge Scale</title>
          <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At Baseline, this scale measures LVAD knowledge before patients receive any formal education (from their LVAD coordinators and/or physicians) about LVAD therapy.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6" spread="22.2"/>
                    <measurement group_id="O2" value="43.8" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Left Ventricular Assist Device (LVAD) Knowledge Scale</title>
        <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 week following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.</description>
        <time_frame>1-Week Follow-up</time_frame>
        <population>Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=29, no-DA=34, Total=63).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Assist Device (LVAD) Knowledge Scale</title>
          <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 week following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.</description>
          <population>Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=29, no-DA=34, Total=63).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.8" spread="15.6"/>
                    <measurement group_id="O2" value="59.3" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The model uses a general linear mixed model with fixed effects for baseline Knowledge Scale score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Left Ventricular Assist Device (LVAD) Knowledge Scale</title>
        <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 month following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.</description>
        <time_frame>1-Month Follow-up</time_frame>
        <population>Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=31, Total=58).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Left Ventricular Assist Device (LVAD) Knowledge Scale</title>
          <description>Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 month following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.</description>
          <population>Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=31, Total=58).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9" spread="5.7"/>
                    <measurement group_id="O2" value="22.9" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The model uses a general linear mixed model with fixed effects for baseline KS score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.47</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decisional Conflict Scale</title>
        <description>Measures the construct of decisional conflict, using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.</description>
        <time_frame>Baseline</time_frame>
        <population>Analysis includes only those participants who completed the measure at Baseline (DA=44, no-DA=50, Total=94).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Decisional Conflict Scale</title>
          <description>Measures the construct of decisional conflict, using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.</description>
          <population>Analysis includes only those participants who completed the measure at Baseline (DA=44, no-DA=50, Total=94).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" spread="20.7"/>
                    <measurement group_id="O2" value="29.3" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Decisional Conflict Scale</title>
        <description>Measures the construct of decisional conflict (at this timepoint, 1 week after baseline), using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.</description>
        <time_frame>1 Week Follow-up</time_frame>
        <population>Analysis includes only those participants who completed the measure at Baseline (DA=29, no-DA=33, Total=62).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Decisional Conflict Scale</title>
          <description>Measures the construct of decisional conflict (at this timepoint, 1 week after baseline), using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.</description>
          <population>Analysis includes only those participants who completed the measure at Baseline (DA=29, no-DA=33, Total=62).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7" spread="11.8"/>
                    <measurement group_id="O2" value="17.4" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.79</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>collaboRATE-Shared Decision Making</title>
        <description>Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 week after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.</description>
        <time_frame>1 Week Follow-up</time_frame>
        <population>Analysis only includes participants who responded to the measure at 1-Week Follow-Up (DA=28, no-DA=34, Total=62).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>collaboRATE-Shared Decision Making</title>
          <description>Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 week after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.</description>
          <population>Analysis only includes participants who responded to the measure at 1-Week Follow-Up (DA=28, no-DA=34, Total=62).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.4" spread="19.3"/>
                    <measurement group_id="O2" value="89.6" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.99</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>collaboRATE-Shared Decision Making</title>
        <description>Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.</description>
        <time_frame>1 Month Follow-up</time_frame>
        <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=57).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>collaboRATE-Shared Decision Making</title>
          <description>Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.</description>
          <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=57).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.4" spread="14.3"/>
                    <measurement group_id="O2" value="89.8" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.94</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Decision Making Process</title>
        <description>Measures a participant's satisfaction with their decision of treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater satisfaction with the decision making process, a more positive outcome), with scores ranging from 0-100.</description>
        <time_frame>1 Month Follow-up</time_frame>
        <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Decision Making Process</title>
          <description>Measures a participant's satisfaction with their decision of treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater satisfaction with the decision making process, a more positive outcome), with scores ranging from 0-100.</description>
          <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.6" spread="23.7"/>
                    <measurement group_id="O2" value="76.8" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ottawa Decision Regret Scale</title>
        <description>The 'Decision Regret Scale' measures &quot;distress or remorse after a (health care) decision.&quot; In a short introductory statement, respondents should be asked to reflect on a specific past decision, and then asked to indicate the extent to which they agree or disagree with the statements in the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. Regret is measured at a point in time when the respondent can reflect on the effects of the decision. Items 2 and 4 should be reverse coded so that, for each item, a higher number will indicate more regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.</description>
        <time_frame>1 Month Follow-up</time_frame>
        <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Ottawa Decision Regret Scale</title>
          <description>The 'Decision Regret Scale' measures &quot;distress or remorse after a (health care) decision.&quot; In a short introductory statement, respondents should be asked to reflect on a specific past decision, and then asked to indicate the extent to which they agree or disagree with the statements in the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. Regret is measured at a point in time when the respondent can reflect on the effects of the decision. Items 2 and 4 should be reverse coded so that, for each item, a higher number will indicate more regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.</description>
          <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" spread="13.3"/>
                    <measurement group_id="O2" value="12.9" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.95</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Life Scale</title>
        <description>Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Life Scale</title>
          <description>Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="6.6"/>
                    <measurement group_id="O2" value="20.4" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Life Scale</title>
        <description>Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
        <time_frame>1 Month Follow-up</time_frame>
        <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Life Scale</title>
          <description>Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
          <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9" spread="6.7"/>
                    <measurement group_id="O2" value="22.9" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preparedness for Decision-Making Scale</title>
        <description>The Preparedness for Decision-Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision (treatment/diagnostic/screening, etc.). Items can be summed and scored (sum the 10 items and divide by 10). B) Scores are converted to a 0-100 scale by: subtracting 1 from the summed score in part a) and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision-making.</description>
        <time_frame>1 Week Follow-up</time_frame>
        <population>Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=33, Total=60).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Preparedness for Decision-Making Scale</title>
          <description>The Preparedness for Decision-Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision (treatment/diagnostic/screening, etc.). Items can be summed and scored (sum the 10 items and divide by 10). B) Scores are converted to a 0-100 scale by: subtracting 1 from the summed score in part a) and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision-making.</description>
          <population>Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=33, Total=60).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9" spread="15.1"/>
                    <measurement group_id="O2" value="81.8" spread="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.27</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.</title>
        <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
        <time_frame>1 Day Follow-up</time_frame>
        <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.</title>
          <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
          <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Strongly Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Strongly Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shared Decision-Making (SDM-9)</title>
        <description>A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.</description>
        <time_frame>1-Week Follow-Up</time_frame>
        <population>Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=34, Total=61).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Shared Decision-Making (SDM-9)</title>
          <description>A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.</description>
          <population>Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=34, Total=61).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8" spread="16.8"/>
                    <measurement group_id="O2" value="84.3" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.65</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shared Decision-Making (SDM-9)</title>
        <description>A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.</description>
        <time_frame>1-Month Follow-Up</time_frame>
        <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=25, no-DA=31, Total=56).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Shared Decision-Making (SDM-9)</title>
          <description>A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.</description>
          <population>Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=25, no-DA=31, Total=56).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5" spread="12.8"/>
                    <measurement group_id="O2" value="85.2" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.74</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up</title>
        <description>Measure of the degree (percentage) of match in patient-reported preferences related to control over treatment decision at Baseline and 1-Month. This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points. The results are reported as the number of participants with a 1:1 &quot;match&quot; in preferences at both time points.</description>
        <time_frame>1-Month Follow-Up</time_frame>
        <population>Analysis only included participants who completed the measure at both Baseline and 1-Month followup, in order to calculate &quot;match&quot; in preferences.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up</title>
          <description>Measure of the degree (percentage) of match in patient-reported preferences related to control over treatment decision at Baseline and 1-Month. This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points. The results are reported as the number of participants with a 1:1 &quot;match&quot; in preferences at both time points.</description>
          <population>Analysis only included participants who completed the measure at both Baseline and 1-Month followup, in order to calculate &quot;match&quot; in preferences.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect</title>
        <description>Percentage of patients reporting that their ability to envision life with an LVAD was &quot;Somewhat Easy&quot; or &quot;Easy.&quot;</description>
        <time_frame>1-Week Follow-Up</time_frame>
        <population>Analysis only includes those who responded to this measure (DA=27, no-DA =33, Total=60).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect</title>
          <description>Percentage of patients reporting that their ability to envision life with an LVAD was &quot;Somewhat Easy&quot; or &quot;Easy.&quot;</description>
          <population>Analysis only includes those who responded to this measure (DA=27, no-DA =33, Total=60).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect</title>
        <description>Number and percentage of patients reporting that their ability to envision life with an LVAD was &quot;Difficult&quot; or that they had &quot;No idea.&quot;</description>
        <time_frame>1-Month Follow-Up</time_frame>
        <population>Analysis only includes those who responded to this measure (DA=20, no-DA =21, Total=41).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect</title>
          <description>Number and percentage of patients reporting that their ability to envision life with an LVAD was &quot;Difficult&quot; or that they had &quot;No idea.&quot;</description>
          <population>Analysis only includes those who responded to this measure (DA=20, no-DA =21, Total=41).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number &amp; Percentage of Participants Who Perceived a Strong Likelihood of Transplant</title>
        <description>Measures the number and percentage of participants who perceived a strong likelihood of transplant.</description>
        <time_frame>1-Week Follow-Up</time_frame>
        <population>Analysis included only those participants who responded to the measure at 1-week (DA=26, no=DA=33, Total=59).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Number &amp; Percentage of Participants Who Perceived a Strong Likelihood of Transplant</title>
          <description>Measures the number and percentage of participants who perceived a strong likelihood of transplant.</description>
          <population>Analysis included only those participants who responded to the measure at 1-week (DA=26, no=DA=33, Total=59).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.60</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant</title>
        <description>Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.</description>
        <time_frame>1-Month Follow-Up</time_frame>
        <population>Analysis included only those participants who responded to the measure at 1-month (DA=27, no-DA=31, Total=58).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant</title>
          <description>Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.</description>
          <population>Analysis included only those participants who responded to the measure at 1-month (DA=27, no-DA=31, Total=58).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.27</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants' Perceived Survival Estimate in Number of Years After LVAD Implant</title>
        <description>Patient-reported estimate of number of years the average patient is able to live after LVAD implant. Participants wrote in a number in a blank space, and numbers were recorded.</description>
        <time_frame>1-Week Follow-Up</time_frame>
        <population>Analysis only includes those participants who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=28, Total=55).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants' Perceived Survival Estimate in Number of Years After LVAD Implant</title>
          <description>Patient-reported estimate of number of years the average patient is able to live after LVAD implant. Participants wrote in a number in a blank space, and numbers were recorded.</description>
          <population>Analysis only includes those participants who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=28, Total=55).</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.17" spread="7.14"/>
                    <measurement group_id="O2" value="9.7" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.45</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Life</title>
        <description>Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
        <time_frame>1-Month Follow-Up</time_frame>
        <population>Analysis only included those participants who completed the measure at 1-Month Follow-Up (DA=26, no=DA=30, Total=56).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Life</title>
          <description>Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.</description>
          <population>Analysis only included those participants who completed the measure at 1-Month Follow-Up (DA=26, no=DA=30, Total=56).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9" spread="5.7"/>
                    <measurement group_id="O2" value="22.9" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life -- Health Rating</title>
        <description>Responses to the question: &quot;On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?&quot;</description>
        <time_frame>Baseline</time_frame>
        <population>Analysis included only those participants who completed the measure at baseline (DA=46, no-DA=50, Total=96).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life -- Health Rating</title>
          <description>Responses to the question: &quot;On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?&quot;</description>
          <population>Analysis included only those participants who completed the measure at baseline (DA=46, no-DA=50, Total=96).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.8" spread="24.0"/>
                    <measurement group_id="O2" value="43.1" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life -- Health Rating</title>
        <description>Responses to the question: &quot;On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?&quot;</description>
        <time_frame>1-Month Follow-Up</time_frame>
        <population>Analysis included only those participants who completed measure at 1-Month (DA=26, no-DA=30, Total=56).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life -- Health Rating</title>
          <description>Responses to the question: &quot;On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?&quot;</description>
          <population>Analysis included only those participants who completed measure at 1-Month (DA=26, no-DA=30, Total=56).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.0" spread="3.7"/>
                    <measurement group_id="O2" value="69.1" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preferred Treatment: Number of Patients Predicting They Will Choose LVAD</title>
        <description>Number of patients forecasting that they will choose LVAD treatment (before their actual decision), measured using a binary score representing yes (1) or no (0) indicating whether a patient predicted they would choose LVAD as a preferred treatment for their advanced heart failure.</description>
        <time_frame>Baseline</time_frame>
        <population>Analysis only includes participants who responded to the question at baseline (DA=46, no-DA=50, Total=96).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Preferred Treatment: Number of Patients Predicting They Will Choose LVAD</title>
          <description>Number of patients forecasting that they will choose LVAD treatment (before their actual decision), measured using a binary score representing yes (1) or no (0) indicating whether a patient predicted they would choose LVAD as a preferred treatment for their advanced heart failure.</description>
          <population>Analysis only includes participants who responded to the question at baseline (DA=46, no-DA=50, Total=96).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Whose Preferred Treatment Was LVAD</title>
        <description>Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.</description>
        <time_frame>1-Week Follow-Up</time_frame>
        <population>Analysis only includes participants who responded to the question at 1-Week (DA=28, no-DA=33, Total=61).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Whose Preferred Treatment Was LVAD</title>
          <description>Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.</description>
          <population>Analysis only includes participants who responded to the question at 1-Week (DA=28, no-DA=33, Total=61).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.77</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Whose Preferred Treatment Was LVAD</title>
        <description>Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.</description>
        <time_frame>1-Month Follow-Up</time_frame>
        <population>Analysis only includes participants who responded to the question at 1-Month (DA=26, no-DA=32, Total=58).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Whose Preferred Treatment Was LVAD</title>
          <description>Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.</description>
          <population>Analysis only includes participants who responded to the question at 1-Month (DA=26, no-DA=32, Total=58).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.74</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Percentage of Patients Who Filled Out an Advanced Directive</title>
        <description>Number and percentage of patients who filled out an Advanced Directive, using a binary measure indicating whether a respondent has filled out an advanced directive (1) or not (0).</description>
        <time_frame>1-Month Follow-Up</time_frame>
        <population>Analysis only includes participants who responded to the question (DA=25, no-DA=27, Total=52).</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Percentage of Patients Who Filled Out an Advanced Directive</title>
          <description>Number and percentage of patients who filled out an Advanced Directive, using a binary measure indicating whether a respondent has filled out an advanced directive (1) or not (0).</description>
          <population>Analysis only includes participants who responded to the question (DA=25, no-DA=27, Total=52).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.</title>
        <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
        <time_frame>1 Day Follow-up</time_frame>
        <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.</title>
          <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
          <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Strongly Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Strongly Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability and Acceptability: Learned Something New That I Didn't Know Before.</title>
        <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
        <time_frame>1 Day Follow-up</time_frame>
        <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability and Acceptability: Learned Something New That I Didn't Know Before.</title>
          <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
          <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Strongly Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Agree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Neutral</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Strongly Disagree</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability and Acceptability: Would Recommend to Others.</title>
        <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
        <time_frame>1 Day Follow-up</time_frame>
        <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 37 patients in the DA group. The no-DA group did not receive the measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability and Acceptability: Would Recommend to Others.</title>
          <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
          <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 37 patients in the DA group. The no-DA group did not receive the measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability and Acceptability: Held my Interest.</title>
        <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
        <time_frame>1 Day Follow-up</time_frame>
        <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 37 patients in the DA group. The no-DA group did not receive the measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability and Acceptability: Held my Interest.</title>
          <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
          <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 37 patients in the DA group. The no-DA group did not receive the measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability and Acceptability: Helps Someone Make an Informed Decision.</title>
        <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
        <time_frame>1 Day Follow-up</time_frame>
        <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability and Acceptability: Helps Someone Make an Informed Decision.</title>
          <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
          <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.</title>
        <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
        <time_frame>1 Day Follow-up</time_frame>
        <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.</title>
          <description>Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool</description>
          <population>Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unsure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants' Control Preferences Over Treatment Decision-Making</title>
        <description>This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points.</description>
        <time_frame>Baseline</time_frame>
        <population>Analysis only included participants who completed the measure at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants' Control Preferences Over Treatment Decision-Making</title>
          <description>This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points.</description>
          <population>Analysis only included participants who completed the measure at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patient made final decision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient, after seriously considering doctor opinio</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctor and patient shared responsibility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctor made decision after considering patient opi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All decisions left to doctor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.98</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participants' Control Preferences Over Treatment Decision-Making</title>
        <description>This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points (baseline and 1-month follow-up).</description>
        <time_frame>1-Month</time_frame>
        <population>Analysis only included participants who completed the measure at baseline, minus participants lost to attrition between baseline and 1-month follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>LVAD Decision Aid</title>
            <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
          </group>
          <group group_id="O2">
            <title>No LVAD Decision Aid</title>
            <description>The standard education process is institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants' Control Preferences Over Treatment Decision-Making</title>
          <description>This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points (baseline and 1-month follow-up).</description>
          <population>Analysis only included participants who completed the measure at baseline, minus participants lost to attrition between baseline and 1-month follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patient made final decision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient, after seriously considering doctor opinio</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctor and patient shared responsibility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctor made decision after considering patient opi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All decisions left to doctor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.20</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events data were monitored and assessed over a period of 3 years, from the beginning of Aim 1 to the end of Aim 2 of the study, using patient data files kept by LVAD coordinators at participating clinics and given to us securely.</time_frame>
      <desc>The definition of adverse event and/or serious adverse event, used to collect adverse event information, did not differ from the clinicaltrials.gov definitions.</desc>
      <group_list>
        <group group_id="E1">
          <title>LVAD Decision Aid</title>
          <description>Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.&#xD;
LVAD Decision Aid: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.&#xD;
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).</description>
        </group>
        <group group_id="E2">
          <title>No LVAD Decision Aid</title>
          <description>The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>No significant limitations to report. One consideration is that because we tested for efficacy at sites with established LVAD programs, results may not be generalizable to other less well-run programs, where effect sizes may be even greater.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Jennifer Blumenthal-Barby</name_or_title>
      <organization>Baylor College of Medicine</organization>
      <phone>(713) 798-3785</phone>
      <email>jennifer.blumenthal-barby@bcm.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02248974
org study id: H-34286
secondary id: CDR-1306-01769
nct id: NCT02248974
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The goal of this project is to develop a patient-centered decision aid for decision-making
      about end-stage heart failure treatment. This study seeks to create a decision aid that
      presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular
      Assist Device (LVAD) placement to help patients make values-based decisions about placement.
      The investigators propose a mixed methods design involving a literature search of clinical
      evidence, semi-structured patient interviews, and quantitative data from a multi-site trial
      of patients receiving the decision aid compared to patients not receiving the aid.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Left Ventricular Assist Device (LVAD) Knowledge Scale
time frame: Baseline
description: Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At Baseline, this scale measures LVAD knowledge before patients receive any formal education (from their LVAD coordinators and/or physicians) about LVAD therapy.
measure: Left Ventricular Assist Device (LVAD) Knowledge Scale
time frame: 1-Week Follow-up
description: Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 week following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.
measure: Left Ventricular Assist Device (LVAD) Knowledge Scale
time frame: 1-Month Follow-up
description: Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 month following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.
measure: Decisional Conflict Scale
time frame: Baseline
description: Measures the construct of decisional conflict, using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.
measure: Decisional Conflict Scale
time frame: 1 Week Follow-up
description: Measures the construct of decisional conflict (at this timepoint, 1 week after baseline), using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.
measure: collaboRATE-Shared Decision Making
time frame: 1 Week Follow-up
description: Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 week after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.
measure: collaboRATE-Shared Decision Making
time frame: 1 Month Follow-up
description: Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.
measure: Satisfaction With Decision Making Process
time frame: 1 Month Follow-up
description: Measures a participant's satisfaction with their decision of treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater satisfaction with the decision making process, a more positive outcome), with scores ranging from 0-100.
measure: Ottawa Decision Regret Scale
time frame: 1 Month Follow-up
description: The 'Decision Regret Scale' measures "distress or remorse after a (health care) decision." In a short introductory statement, respondents should be asked to reflect on a specific past decision, and then asked to indicate the extent to which they agree or disagree with the statements in the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. Regret is measured at a point in time when the respondent can reflect on the effects of the decision. Items 2 and 4 should be reverse coded so that, for each item, a higher number will indicate more regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret.
measure: Satisfaction With Life Scale
time frame: Baseline
description: Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
measure: Satisfaction With Life Scale
time frame: 1 Month Follow-up
description: Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
measure: Preparedness for Decision-Making Scale
time frame: 1 Week Follow-up
description: The Preparedness for Decision-Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision (treatment/diagnostic/screening, etc.). Items can be summed and scored (sum the 10 items and divide by 10). B) Scores are converted to a 0-100 scale by: subtracting 1 from the summed score in part a) and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision-making.
measure: Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.
time frame: 1 Day Follow-up
description: Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
measure: Shared Decision-Making (SDM-9)
time frame: 1-Week Follow-Up
description: A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.
measure: Shared Decision-Making (SDM-9)
time frame: 1-Month Follow-Up
description: A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.
measure: Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up
time frame: 1-Month Follow-Up
description: Measure of the degree (percentage) of match in patient-reported preferences related to control over treatment decision at Baseline and 1-Month. This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points. The results are reported as the number of participants with a 1:1 "match" in preferences at both time points.
measure: Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect
time frame: 1-Week Follow-Up
description: Percentage of patients reporting that their ability to envision life with an LVAD was "Somewhat Easy" or "Easy."
measure: Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect
time frame: 1-Month Follow-Up
description: Number and percentage of patients reporting that their ability to envision life with an LVAD was "Difficult" or that they had "No idea."
measure: Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant
time frame: 1-Week Follow-Up
description: Measures the number and percentage of participants who perceived a strong likelihood of transplant.
measure: Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant
time frame: 1-Month Follow-Up
description: Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.
measure: Participants' Perceived Survival Estimate in Number of Years After LVAD Implant
time frame: 1-Week Follow-Up
description: Patient-reported estimate of number of years the average patient is able to live after LVAD implant. Participants wrote in a number in a blank space, and numbers were recorded.
measure: Satisfaction With Life
time frame: 1-Month Follow-Up
description: Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.
measure: Quality of Life -- Health Rating
time frame: Baseline
description: Responses to the question: "On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?"
measure: Quality of Life -- Health Rating
time frame: 1-Month Follow-Up
description: Responses to the question: "On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?"
measure: Preferred Treatment: Number of Patients Predicting They Will Choose LVAD
time frame: Baseline
description: Number of patients forecasting that they will choose LVAD treatment (before their actual decision), measured using a binary score representing yes (1) or no (0) indicating whether a patient predicted they would choose LVAD as a preferred treatment for their advanced heart failure.
measure: Number of Patients Whose Preferred Treatment Was LVAD
time frame: 1-Week Follow-Up
description: Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.
measure: Number of Patients Whose Preferred Treatment Was LVAD
time frame: 1-Month Follow-Up
description: Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.
measure: Number and Percentage of Patients Who Filled Out an Advanced Directive
time frame: 1-Month Follow-Up
description: Number and percentage of patients who filled out an Advanced Directive, using a binary measure indicating whether a respondent has filled out an advanced directive (1) or not (0).
measure: Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.
time frame: 1 Day Follow-up
description: Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
measure: Usability and Acceptability: Learned Something New That I Didn't Know Before.
time frame: 1 Day Follow-up
description: Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
measure: Usability and Acceptability: Would Recommend to Others.
time frame: 1 Day Follow-up
description: Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
measure: Usability and Acceptability: Held my Interest.
time frame: 1 Day Follow-up
description: Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
measure: Usability and Acceptability: Helps Someone Make an Informed Decision.
time frame: 1 Day Follow-up
description: Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
measure: Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.
time frame: 1 Day Follow-up
description: Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool
measure: Participants' Control Preferences Over Treatment Decision-Making
time frame: Baseline
description: This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points.
measure: Participants' Control Preferences Over Treatment Decision-Making
time frame: 1-Month
description: This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points (baseline and 1-month follow-up).
arm group label: LVAD Decision Aid
arm group type: Active Comparator
description: Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
arm group label: No LVAD Decision Aid
arm group type: No Intervention
description: The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
intervention type: Other
intervention name: LVAD Decision Aid
description: Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
arm group label: LVAD Decision Aid
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jennifer Blumenthal-Barby, PhD
role: Principal Investigator
affiliation: Baylor College of Medicine
last name: Kristin M Kostick, PhD
role: Study Director
affiliation: Baylor College of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.lvaddecisionaid.com
description: Project Website
citation: Bruce CR, Delgado E, Kostick K, Grogan S, Ashrith G, Trachtenberg B, Estep JD, Bhimaraj A, Pham L, Blumenthal-Barby JS. Ventricular assist devices: a review of psychosocial risk factors and their impact on outcomes. J Card Fail. 2014 Dec;20(12):996-1003. doi: 10.1016/j.cardfail.2014.09.006. Epub 2014 Sep 17.
PMID: 25239054
citation: Blumenthal-Barby, J. S., Kristin M. Kostick, Estevan D. Delgado, Robert J. Volk, Holland M. Kaplan, L. A. Wilhelms, Sheryl A. McCurdy, Jerry D. Estep, Matthias Loebe, and Courtenay R. Bruce.
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Jennifer Blumenthal-Barby
investigator title: Assistant Professor of Philosophy/Bioethics
mesh term: Heart Failure
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No significant limitations to report. One consideration is that because we tested for efficacy at sites with established LVAD programs, results may not be generalizable to other less well-run programs, where effect sizes may be even greater.
point of contact: 