<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/NCT03794700</url>
  </required_header>
  <id_info>
    <org_study_id>18-1138</org_study_id>
    <secondary_id>1R21AG059114-01</secondary_id>
    <nct_id>NCT03794700</nct_id>
  </id_info>
  <brief_title>Pilot Evaluation of Hospice Decision Support Tools</brief_title>
  <official_title>Pilot Evaluation of Hospice Decision Support Tools</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to determine the feasibility and acceptability of a hospice&#xD;
      decision aid among a diverse population of older adults at multiple stages of illness (Aim 1)&#xD;
      and to determine the preliminary efficacy of the hospice decision aid on decision quality,&#xD;
      hospice knowledge, and values-concordance (Aim 2). By testing the feasibility, acceptability,&#xD;
      and preliminary efficacy of a novel hospice Patient Decision Aid (PTDa) in a diverse&#xD;
      population of older adults, additionally the study will simultaneously explore barriers to&#xD;
      PtDA implementation in both an outpatient primary care and inpatient palliative care setting.&#xD;
      The study will also gather sufficient pilot data to support a subsequent&#xD;
      effectiveness/implementation trial and thus address the absence of quality of SDM&#xD;
      interventions for end-of-life care decision-making.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2018</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospice Knowledge Scale</measure>
    <time_frame>1 month follow-up</time_frame>
    <description>Hospice Knowledge Scale is a 23-item true/false scale that measures patient knowledge about hospice care. Each question is worth 1 point with possible scores ranging from 0 to 23. Higher scores indicate more knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospice Beliefs and Attitudes Scale</measure>
    <time_frame>1-Month follow up</time_frame>
    <description>8-item scale developed to measure beliefs and attitudes towards hospice care. It has a Cronbach's α = .74 for the scale, indicating a good degree of internal reliability. Scores from 8 to 40. Higher scores indicate better opinions of hospice. .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decision Self Efficacy Scale</measure>
    <time_frame>1 month Follow up</time_frame>
    <description>Is an 11-item instrument that one's self-confidence in decision making. This scale is a validated scale with a Cronbach's alpha of 0.92 and correlates with DCS subscale of being informed (r=0.47). Scored from 0-100 with higher scores indicating more decision self efficacy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Hospice</condition>
  <condition>End-of-life Decision Making</condition>
  <condition>Hospice Decision Making</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hospice Decision Aids</intervention_name>
    <description>Paper and video hospice decision aid</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  65 or older.&#xD;
&#xD;
          -  At least one life-limiting illness or syndrome.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers.&#xD;
&#xD;
          -  Patients with cognitive Impairments preventing ability to provide informed consent.&#xD;
&#xD;
          -  Patients on isolation precautions due to resistant bacteria or impaired immune&#xD;
             function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Matlock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <results_first_submitted>July 13, 2022</results_first_submitted>
  <results_first_submitted_qc>August 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2022</results_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hospice</keyword>
  <keyword>End-of-life</keyword>
  <keyword>Patient decision aid</keyword>
  <keyword>Shared decision making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03794700/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>No Hospice Decision Aid</title>
          <description>Did not receive the intervention (i.e. Hospice Decision Aid)</description>
        </group>
        <group group_id="P2">
          <title>Hospice Decision Aid</title>
          <description>Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.&#xD;
Hospice Decision Aids: Paper and video hospice decision aid</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="88"/>
              </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_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Participants did not review the intervention (i.e. Hospice Decision Aid)</description>
        </group>
        <group group_id="B2">
          <title>Intervention</title>
          <description>Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.&#xD;
Hospice Decision Aids: Paper and video hospice decision aid</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="43"/>
            <count group_id="B2" value="88"/>
            <count group_id="B3" value="131"/>
          </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="131"/>
                  </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="28"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="47"/>
                  </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="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hospice Knowledge Test</title>
          <description>Hospice knowledge was quantitatively assessed using the 23-item hospice knowledge survey.This survey consists of true/false questions, with scores ranging from 0 to 23, awarding one point for each correct answer. A higher score indicates more knowledge of hospice. The Cronbach's α = 0.75 indicates a good degree of internal reliability. Absolute values measured at baseline and one month</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18" lower_limit="12" upper_limit="23"/>
                    <measurement group_id="B2" value="18" lower_limit="0" upper_limit="23"/>
                    <measurement group_id="B3" value="18" lower_limit="0" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hospice Beliefs and Attitudes Scale</title>
          <description>The HBAS is an 8-item scale designed to measure beliefs and attitudes regarding hospice care. T Cronbach's α = .74 for the scale, indicating a good degree of internal reliability.The HBAS is scored from 8 to 40, with a higher score indicating more positive views of hospice care. The scale uses a 5-item Likert scale with answers ranging from &quot;strongly disagree&quot; to &quot;strongly agree&quot; for all questions. Absolute values measured at baseline and one month</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29" lower_limit="18" upper_limit="40"/>
                    <measurement group_id="B2" value="29" lower_limit="12" upper_limit="40"/>
                    <measurement group_id="B3" value="29" lower_limit="12" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Decision Self Efficacy Scale</title>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92" lower_limit="66" upper_limit="100"/>
                    <measurement group_id="B2" value="87" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="B3" value="89" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hospice Knowledge Scale</title>
        <description>Hospice Knowledge Scale is a 23-item true/false scale that measures patient knowledge about hospice care. Each question is worth 1 point with possible scores ranging from 0 to 23. Higher scores indicate more knowledge.</description>
        <time_frame>1 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Did not receive intervention (i.e. Patient Decision Aid)</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.&#xD;
Hospice Decision Aids: Paper and video hospice decision aid</description>
          </group>
        </group_list>
        <measure>
          <title>Hospice Knowledge Scale</title>
          <description>Hospice Knowledge Scale is a 23-item true/false scale that measures patient knowledge about hospice care. Each question is worth 1 point with possible scores ranging from 0 to 23. Higher scores indicate more knowledge.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" lower_limit="0" upper_limit="23"/>
                    <measurement group_id="O2" value="17" lower_limit="0" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Hospice Beliefs and Attitudes Scale</title>
        <description>8-item scale developed to measure beliefs and attitudes towards hospice care. It has a Cronbach's α = .74 for the scale, indicating a good degree of internal reliability. Scores from 8 to 40. Higher scores indicate better opinions of hospice. .</description>
        <time_frame>1-Month follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Did not receive intervention (i.e. Patient Decision Aid)</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.&#xD;
Hospice Decision Aids: Paper and video hospice decision aid</description>
          </group>
        </group_list>
        <measure>
          <title>Hospice Beliefs and Attitudes Scale</title>
          <description>8-item scale developed to measure beliefs and attitudes towards hospice care. It has a Cronbach's α = .74 for the scale, indicating a good degree of internal reliability. Scores from 8 to 40. Higher scores indicate better opinions of hospice. .</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" lower_limit="26" upper_limit="40"/>
                    <measurement group_id="O2" value="33" lower_limit="11" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Decision Self Efficacy Scale</title>
        <description>Is an 11-item instrument that one's self-confidence in decision making. This scale is a validated scale with a Cronbach's alpha of 0.92 and correlates with DCS subscale of being informed (r=0.47). Scored from 0-100 with higher scores indicating more decision self efficacy.</description>
        <time_frame>1 month Follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Did not receive intervention (i.e. Patient Decision Aid)</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.&#xD;
Hospice Decision Aids: Paper and video hospice decision aid</description>
          </group>
        </group_list>
        <measure>
          <title>Decision Self Efficacy Scale</title>
          <description>Is an 11-item instrument that one's self-confidence in decision making. This scale is a validated scale with a Cronbach's alpha of 0.92 and correlates with DCS subscale of being informed (r=0.47). Scored from 0-100 with higher scores indicating more decision self efficacy.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" lower_limit="43" upper_limit="100"/>
                    <measurement group_id="O2" value="94" lower_limit="67" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Did not receive intervention (i.e. Patient Decision aid)</description>
        </group>
        <group group_id="E2">
          <title>Intervention</title>
          <description>Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.&#xD;
Hospice Decision Aids: Paper and video hospice decision aid</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Channing Tate, PHD Assistant Professor</name_or_title>
      <organization>University of Colorado Anschutz Medical Campus</organization>
      <phone>3037248985</phone>
      <email>channing.tate@cuanschutz.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/NCT03794700
org study id: 18-1138
secondary id: 1R21AG059114-01
nct id: NCT03794700
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this project is to determine the feasibility and acceptability of a hospice
      decision aid among a diverse population of older adults at multiple stages of illness (Aim 1)
      and to determine the preliminary efficacy of the hospice decision aid on decision quality,
      hospice knowledge, and values-concordance (Aim 2). By testing the feasibility, acceptability,
      and preliminary efficacy of a novel hospice Patient Decision Aid (PTDa) in a diverse
      population of older adults, additionally the study will simultaneously explore barriers to
      PtDA implementation in both an outpatient primary care and inpatient palliative care setting.
      The study will also gather sufficient pilot data to support a subsequent
      effectiveness/implementation trial and thus address the absence of quality of SDM
      interventions for end-of-life care decision-making.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Hospice Knowledge Scale
time frame: 1 month follow-up
description: Hospice Knowledge Scale is a 23-item true/false scale that measures patient knowledge about hospice care. Each question is worth 1 point with possible scores ranging from 0 to 23. Higher scores indicate more knowledge.
measure: Hospice Beliefs and Attitudes Scale
time frame: 1-Month follow up
description: 8-item scale developed to measure beliefs and attitudes towards hospice care. It has a Cronbach's α = .74 for the scale, indicating a good degree of internal reliability. Scores from 8 to 40. Higher scores indicate better opinions of hospice. .
measure: Decision Self Efficacy Scale
time frame: 1 month Follow up
description: Is an 11-item instrument that one's self-confidence in decision making. This scale is a validated scale with a Cronbach's alpha of 0.92 and correlates with DCS subscale of being informed (r=0.47). Scored from 0-100 with higher scores indicating more decision self efficacy.
arm group label: Control
arm group type: No Intervention
arm group label: Intervention
arm group type: Other
description: Participants will receive hospice decisional support materials and be asked to review them. Participants will provide feedback on tools and complete feasibility, efficacy and knowledge assessments.
intervention type: Other
intervention name: Hospice Decision Aids
description: Paper and video hospice decision aid
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Matlock, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Death
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 