<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/NCT04437069</url>
  </required_header>
  <id_info>
    <org_study_id>IRB_00103194</org_study_id>
    <nct_id>NCT04437069</nct_id>
  </id_info>
  <brief_title>Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making</brief_title>
  <official_title>Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Utah</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>
      This study is a randomized clinical trial where participants (parents of a fetus or neonate&#xD;
      diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned&#xD;
      to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that&#xD;
      includes a values clarification exercise. Because of the novel use of decision aids in CHD in&#xD;
      an acute setting, we will also compare participants receiving the DA in a randomized control&#xD;
      trial to a prospective observational population of families faced with similar decisions&#xD;
      without a DA (control group). We have designated the Brief Symptom Inventory Global Severity&#xD;
      Index of Global Distress 3 months post-birth or death/termination as our primary outcome&#xD;
      measure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The diagnosis of a life-threatening pediatric heart condition impacts both the future of a&#xD;
      child and the health and quality of life of the family. Parents of a child with this&#xD;
      diagnosis are faced with the stress of comprehending extensive information about the&#xD;
      diagnosis and treatment options, and are required to make immediate and profound choices&#xD;
      about interventions that will have long-lasting repercussions. To provide the best care at&#xD;
      this challenging time, it is crucial to find methods to improve parent-provider shared&#xD;
      decision making (SDM) and to encourage the inclusion of both patient-centered and&#xD;
      family-centered outcomes. One method commonly used to improve SDM are decision aids (DA). DAs&#xD;
      are designed to 1) provide accurate and balanced information; 2) clarify patients' values;&#xD;
      and 3) improve SDM skills. A Cochrane review showed that DAs contribute to effective SDM by:&#xD;
      1) increasing knowledge of the diagnosis and treatment options, 2) increasing patient and&#xD;
      practitioner participation in SDM, 3) reducing uncertainty and decisional conflict, 4)&#xD;
      improving concordance between preference and treatment received, and 5) improving&#xD;
      patient-provider communication.&#xD;
&#xD;
      Values clarification exercises (VCE) are occasionally included in DAs to help patients&#xD;
      clarify their values about the treatment decision. Although these exercises are often used,&#xD;
      they are poorly tested. Previous systematic reviews have failed to identify rigorous research&#xD;
      studies to answer questions regarding whether VCE improves patient decision making processes.&#xD;
      This project aims to determine the impact of the DA with and without the VCE on longitudinal&#xD;
      parent mental health, decision quality and perceptions of patient-provider communication.&#xD;
      Specifically, we will test the impact of decision aids (DA vs. no DA, and DA with and without&#xD;
      the VCE) on mental health outcomes (e.g., anxiety, complicated grief), decision quality&#xD;
      (e.g., quality of the decision, parent-provider communication), and provider experience&#xD;
      (e.g., satisfaction with interacting with patients who used the tool). In the development of&#xD;
      the DA and VCE, we conducted focus groups and interviews in Utah, Illinois, Washington, D.C,&#xD;
      and North Carolina with parents whose fetus/neonate had been diagnosed with complex CHD. The&#xD;
      main goal of this study is to determine the impact of the DA with and without the VCE on&#xD;
      longitudinal parent mental health, decision quality and provider experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Parents randomized using simple randomization into two conditions: one group receives the patient decision aid, and one group receives the patient decision aid and the values clarification exercise. There is no stratified randomization. There are 4 survey time points: 1) Baseline, 2) Post-Viewing of the Decision Aid (or Decision Aid and Values Clarification Exercise), 3) Post-Decision, and 4) Three Months Post-Decision.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress</measure>
    <time_frame>1 week post baseline &amp; 3 months post-decision</time_frame>
    <description>The BSI is a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous seven days. Answers range in a 5 point Likert scale from 0=not at all to 4=extremely. The scale measures stress, so a lower score is better. Scores are obtained for nine primary symptom dimensions and three global indices of distress.&#xD;
The primary comparison is the baseline measurement versus 3 months post-decision measurement. We are looking at how those measurements changed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decision Quality - Values</measure>
    <time_frame>1 week Post-Decision Aid, 1 month post-decision, &amp; 3 months post-decision</time_frame>
    <description>Six question scale that measures the values that the participant makes while choosing medical treatment. Answers range in a 6-point Likert scale from 1=most important to 6=not as important. There is no right or wrong answer; it is up to patient preference, so no answer indicates a &quot;better&quot; than another.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision Quality - Knowledge</measure>
    <time_frame>1 week Post-Decision Aid, 1 month post-decision, &amp; 3 months post-decision</time_frame>
    <description>27 questions assessing the participant's knowledge of treatment options for CHD. Participants not in the intervention arm will also take this survey for comparison. 21 of the questions use a dichotomous response format (either &quot;true / false&quot; or &quot;yes/no&quot;); 5 questions are multiple choice. All questions are answered with full access to the decision aid (if not in standard care arm) since participants are not meant to test recall. &quot;Better&quot; scores will be measured by how many questions that a participant answers correctly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perinatal Grief</measure>
    <time_frame>1 week Post-Decision Aid, 1 month post-decision, &amp; 3 months post-decision</time_frame>
    <description>Measured using the Perinatal Grief Scale which measures grief, coping, and despair following the death of a child. This scale was also adapted for a child who did not die. Answers are on a 5-point Likert scale that ranges from 1=strongly agree to 5=strongly disagree. A higher score would indicate less grief, and would therefore be considered &quot;better&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Symptom Inventory (BSI) Global Severity Index of Global Distress</measure>
    <time_frame>1 week Post-Decision Aid, 1 month post-decision</time_frame>
    <description>The BSI is a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous seven days. Answers range in a 5 point Likert scale from 0=not at all to 4=extremely. The scale measures stress, so a lower score is better. Scores are obtained for nine primary symptom dimensions and three global indices of distress.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE)</measure>
    <time_frame>1 week Post-Decision Aid, 1 month post-decision, &amp; 3 months post-decision</time_frame>
    <description>COMRADE is validated patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. There are two sub-scales for risk communication and confidence in decision. It allows for paternalistic, shared or informed choice decision making models. There are 10 questions that are answered on a 5 point Likert scale ranging from 1-strongly disagree to 5=strongly agree. Higher scores are better, as they indicate a stronger understanding from the provider.</description>
  </other_outcome>
  <other_outcome>
    <measure>Preference for Shared Decision Making</measure>
    <time_frame>1 week from Baseline, 1 week post-Decision Aid, &amp; 1 month post-decision</time_frame>
    <description>This scale assesses participants' desire to participate in Shared Decision Making. It is an adaptation of the Degner &amp; Sloan's Control Preference Scale. It is a one item question that asks people if they want to make the decision alone, with their clinician, or have their clinician make it. There is no right or wrong answer; it is up to patient preference, so no answer indicates a &quot;better&quot; than another.</description>
  </other_outcome>
  <other_outcome>
    <measure>Preparation for Decision Making</measure>
    <time_frame>1 week Post-Decision Aid</time_frame>
    <description>Preparation for Decision Making Scale is a validated scale which will assess participants' perspectives of the decision aid's usefulness in preparing them to communicate with their clinicians and for Shared Decision Making. These questions are answered on a Likert scale ranging from 1=not at all to 5=a great deal. A higher score indicates that they are better prepared and, thus, a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Decision Self-Efficacy Scale</measure>
    <time_frame>1 week from Baseline, 1 week post-Decision Aid, &amp; 1 month post-decision</time_frame>
    <description>11 question survey that measures self-efficacy for performing informed decision making (e.g., getting needed information, asking questions, expressing opinions). Answers range in a 5 point Likert scale from 0=not at all confident to 4=extremely confident. Higher scores are better, as they indicate stronger self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>1 week Post-Decision Aid, 1 month post-decision, &amp; 3 months post-decision</time_frame>
    <description>A 16-question survey that measures 1) perceptions of uncertainty in choosing options, 2) feelings of having adequate knowledge and clear values, and 3) effective decision making. Answers range on a 5 point Likert scale from 0=strongly agree to 4=strongly disagree. Lower scores are better, as they indicate a stronger knowledge about choice availability.</description>
  </other_outcome>
  <other_outcome>
    <measure>Decisional Regret</measure>
    <time_frame>3 months post-decision</time_frame>
    <description>Decision Regret will be assessed by asking participants to reflect on the decision they made about which treatment option they chose for their child. The measure consists of 5 items assessed on a 5-point Likert scale from &quot;Strongly agree&quot; to &quot;Strongly disagree&quot;. There is no right or wrong answer; it is up to patient preference, so no answer indicates a &quot;better&quot; than another.</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Choice and Treatment Received</measure>
    <time_frame>1 week Post-Decision Aid, 1 month post-decision, &amp; 3 months post-decision</time_frame>
    <description>Treatment Choice will be assessed by asking participants to identify which treatment they chose. Using electronic health records, we will record the child's actual treatment in case of parental change of mind or misreport. A &quot;better&quot; score would be matching the treatment choice declaration with whichever treatment the electronic health record indicates that the patient received.</description>
  </other_outcome>
  <other_outcome>
    <measure>Control Preference Scale</measure>
    <time_frame>1 week post baseline, 1 week post decision aid, 1 month post-decision</time_frame>
    <description>This scale assesses participants' desire to participate in Shared Decision Making. This scale is an adaptation of the Degner &amp; Sloan's Control Preference Scale. It is a one item question that asks people if they want to make the decision alone, with their clinician, or have their clinician make it. There is no right or wrong answer; it is up to patient preference, so no answer indicates a &quot;better&quot; than another.</description>
  </other_outcome>
  <other_outcome>
    <measure>Acceptability of the Decision Aid</measure>
    <time_frame>1 week post decision aid</time_frame>
    <description>This will be assessed with 5 questions. Participants will be asked questions about if they used the decision aid (DA) before their appointment or during their appointment, their likelihood to recommend the DA, the amount of information presented, and if the DA seemed biased. There is no &quot;better&quot; or more correct answer; it is up to the patient's opinion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Consultation Quality</measure>
    <time_frame>1 week post baseline, 3 months post decision.</time_frame>
    <description>2 items measuring the quality of consultation. One is asking the participant to rate their usefulness of consultation on a 7 point Likert scale that ranges from 0=not at all useful to 6=very useful. The second is asking the participant if the clinician encouraged any certain treatment. There is no &quot;better&quot; answer, as these are opinions.</description>
  </other_outcome>
  <other_outcome>
    <measure>SF-12</measure>
    <time_frame>1 week post Baseline, 3 months post decision</time_frame>
    <description>The 12-Item Short Form Health Survey (SF-12) is a validated scale measuring the participant's health that was designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. Answers are given on a 5 point Likert scale ranging from 1=excellent to 5=poor for three of the questions (lower scores are better); answers are given in a dichotomous (yes/no) format for four of the questions (&quot;yes&quot; is better); answers are given on a 6 point Likert scale ranging from 1=all of the time to 6=none of the time for three of the questions (lower scores are better); answers are given in a trichotomous format (yes, limited a little; yes, limited a lot; no, not limited at all) for the remaining two questions (&quot;no&quot; is the better answer).</description>
  </other_outcome>
  <other_outcome>
    <measure>Use of Information Sources</measure>
    <time_frame>1 week post decision aid</time_frame>
    <description>Participants indicate whether they consulted any of 10 sources of health information. Of these 10 sources, 2 ask about personal relationships (i.e., relatives and friends), 3 had their roots in massmedia (i.e., exposure to television/movies, magazines, and books about CHD), and 2 were educational/research-based (i.e., scientific journals/research papers and the internet). The remaining 3 sources included providers, support groups, and other parents who have a child with CHD. Answers are in a 5 point Likert scale ranging from 1=never to 5=a great deal. There is no right or wrong answer; it is up to patient preference, so no answer indicates a &quot;better&quot; than another.</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of a Child with Congenital Anomalies on Parents</measure>
    <time_frame>1 month post decision, 3 months post decision</time_frame>
    <description>ICCAP is a validated questionnaire developed to assess the impact of giving birth to a child with severe anatomical congenital anomalies on parental quality of life as a result of early stress. There are 32 questions: 4 ask about contact with caregivers, 6 ask about support from social network, 5 ask about partner relationships, 4 ask about the participant's state of mind, and the remaining 13 ask about fear and anxiety. Answers range on a 4 point Likert scale that ranges from 1=strongly disagree to 4=strongly agree, with a &quot;not applicable&quot;. With the first three categories (contact with caregivers, social network, and partner relationships), a higher score is a &quot;better&quot; score; the remaining two categories (state of mind and fear/anxiety) are reverse-scored, so a lower score is &quot;better&quot;.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">215</enrollment>
  <condition>Patient Decision Aids</condition>
  <condition>Congenital Heart Disease</condition>
  <condition>Congenital Heart Defect</condition>
  <arm_group>
    <arm_group_label>Standard Care (Control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive standard care and will not view either the Decision Aid or the Values Clarification Exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decision Aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants view the Decision Aid only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decision Aid &amp; Values Clarification Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants view both the Decision Aid and the Values Clarification Exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>Participants will view a Decision Aid (delivered as an app) that provides them with information regarding congenital heart disease, as described in the literature. The DA is tailored to the specific diagnosis of the fetus/neonate, so that participants are only viewing information about their baby's specific CHD diagnosis (and not other types of CHD). This is shown using videos and diagrams to clearly explain the defect, what their treatment options are (surgical intervention, comfort care, or termination), and personal stories from other parents who have dealt with the same diagnosis before (including both positive and negative outcomes). The DA was developed according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332).</description>
    <arm_group_label>Decision Aid</arm_group_label>
    <arm_group_label>Decision Aid &amp; Values Clarification Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Values Clarification Exercise</intervention_name>
    <description>The Values Clarification Exercise is a process that aids patients in clarifying their values and goals to improve alignment of their preferences with their chosen treatment. It was developed according to the International Patient Decision Aid Standards. It includes ten values that were chosen based on feedback from the parent investigators and clinicians. The ten values are: 1) discomfort to the child, 2) time in the hospital, 3) risk that the child will have impairments, 4) need to provide home medical care, 5) chronic medical care/decisions, 6) financial issues, 7) life in adulthood, 8) impact on the family, 9) beliefs about doing everything medically possible, &amp; 10) life expectancy. Each value has a sliding scale where the user can compare 2 treatment options at a time. They are asked which described situation feels better for them and their family.</description>
    <arm_group_label>Decision Aid &amp; Values Clarification Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents whose fetus/neonate was diagnosed with a life-threatening CHD that meets&#xD;
             eligibility criteria below without restriction based on gender, race, age, or&#xD;
             socioeconomic status.&#xD;
&#xD;
          -  We will request participation from both parents but will not disqualify families if&#xD;
             only one parent participates.&#xD;
&#xD;
          -  Eligibility Criteria: Parents whose fetus/neonate was diagnosed with a&#xD;
             life-threatening CHD that are offered the choice between intervention and comfort care&#xD;
             (and in some cases termination). This is limited to the following diagnoses: Truncus&#xD;
             Arteriosus, Pulmonary Atresia with Intact Ventricular Septum, Complex Single&#xD;
             Ventricle, Complex Single Ventricle with Heterotaxy, Hypoplastic Left Heart Syndrome&#xD;
             (HLHS), and Ebstein's Anomaly of the Tricuspid Valve.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other types of CHD that are not listed above are not eligible.&#xD;
&#xD;
          -  Participants must be 18 years of age or older&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela Fagerlin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mandy Pershing, MS</last_name>
    <phone>801-587-2460</phone>
    <email>mandy.pershing@hsc.utah.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mandy Pershing, MS</last_name>
      <phone>801-587-2460</phone>
      <email>mandy.pershing@hsc.utah.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mandy Pershing, MS</last_name>
      <phone>801-587-2460</phone>
      <email>mandy.pershing@hsc.utah.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <reference>
    <citation>Fagerlin A, Zikmund-Fisher BJ, Ubel PA, Jankovic A, Derry HA, Smith DM. Measuring numeracy without a math test: development of the Subjective Numeracy Scale. Med Decis Making. 2007 Sep-Oct;27(5):672-80. doi: 10.1177/0272989X07304449. Epub 2007 Jul 19.</citation>
    <PMID>17641137</PMID>
  </reference>
  <reference>
    <citation>Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.</citation>
    <PMID>6622612</PMID>
  </reference>
  <reference>
    <citation>Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.</citation>
    <PMID>12900105</PMID>
  </reference>
  <reference>
    <citation>Bekker HL, Hewison J, Thornton JG. Applying decision analysis to facilitate informed decision making about prenatal diagnosis for Down syndrome: a randomised controlled trial. Prenat Diagn. 2004 Apr;24(4):265-75. doi: 10.1002/pd.851.</citation>
    <PMID>15065100</PMID>
  </reference>
  <reference>
    <citation>Mazer P, Gischler SJ, Koot HM, Tibboel D, van Dijk M, Duivenvoorden HJ. Impact of a child with congenital anomalies on parents (ICCAP) questionnaire; a psychometric analysis. Health Qual Life Outcomes. 2008 Nov 23;6:102. doi: 10.1186/1477-7525-6-102.</citation>
    <PMID>19025612</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Angie Fagerlin</investigator_full_name>
    <investigator_title>Professor &amp; Chair, Department of Population Health Sciences</investigator_title>
  </responsible_party>
  <keyword>values clarification exercise</keyword>
  <keyword>shared decision making</keyword>
  <keyword>patient education</keyword>
  <keyword>patient decision aids</keyword>
  <keyword>congenital heart disease</keyword>
  <keyword>congenital heart defect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04437069
org study id: IRB_00103194
nct id: NCT04437069
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized clinical trial where participants (parents of a fetus or neonate
      diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned
      to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that
      includes a values clarification exercise. Because of the novel use of decision aids in CHD in
      an acute setting, we will also compare participants receiving the DA in a randomized control
      trial to a prospective observational population of families faced with similar decisions
      without a DA (control group). We have designated the Brief Symptom Inventory Global Severity
      Index of Global Distress 3 months post-birth or death/termination as our primary outcome
      measure.
The diagnosis of a life-threatening pediatric heart condition impacts both the future of a
      child and the health and quality of life of the family. Parents of a child with this
      diagnosis are faced with the stress of comprehending extensive information about the
      diagnosis and treatment options, and are required to make immediate and profound choices
      about interventions that will have long-lasting repercussions. To provide the best care at
      this challenging time, it is crucial to find methods to improve parent-provider shared
      decision making (SDM) and to encourage the inclusion of both patient-centered and
      family-centered outcomes. One method commonly used to improve SDM are decision aids (DA). DAs
      are designed to 1) provide accurate and balanced information; 2) clarify patients' values;
      and 3) improve SDM skills. A Cochrane review showed that DAs contribute to effective SDM by:
      1) increasing knowledge of the diagnosis and treatment options, 2) increasing patient and
      practitioner participation in SDM, 3) reducing uncertainty and decisional conflict, 4)
      improving concordance between preference and treatment received, and 5) improving
      patient-provider communication.

      Values clarification exercises (VCE) are occasionally included in DAs to help patients
      clarify their values about the treatment decision. Although these exercises are often used,
      they are poorly tested. Previous systematic reviews have failed to identify rigorous research
      studies to answer questions regarding whether VCE improves patient decision making processes.
      This project aims to determine the impact of the DA with and without the VCE on longitudinal
      parent mental health, decision quality and perceptions of patient-provider communication.
      Specifically, we will test the impact of decision aids (DA vs. no DA, and DA with and without
      the VCE) on mental health outcomes (e.g., anxiety, complicated grief), decision quality
      (e.g., quality of the decision, parent-provider communication), and provider experience
      (e.g., satisfaction with interacting with patients who used the tool). In the development of
      the DA and VCE, we conducted focus groups and interviews in Utah, Illinois, Washington, D.C,
      and North Carolina with parents whose fetus/neonate had been diagnosed with complex CHD. The
      main goal of this study is to determine the impact of the DA with and without the VCE on
      longitudinal parent mental health, decision quality and provider experience.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Parents randomized using simple randomization into two conditions: one group receives the patient decision aid, and one group receives the patient decision aid and the values clarification exercise. There is no stratified randomization. There are 4 survey time points: 1) Baseline, 2) Post-Viewing of the Decision Aid (or Decision Aid and Values Clarification Exercise), 3) Post-Decision, and 4) Three Months Post-Decision.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress
time frame: 1 week post baseline & 3 months post-decision
description: The BSI is a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous seven days. Answers range in a 5 point Likert scale from 0=not at all to 4=extremely. The scale measures stress, so a lower score is better. Scores are obtained for nine primary symptom dimensions and three global indices of distress.
The primary comparison is the baseline measurement versus 3 months post-decision measurement. We are looking at how those measurements changed.
measure: Decision Quality - Values
time frame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
description: Six question scale that measures the values that the participant makes while choosing medical treatment. Answers range in a 6-point Likert scale from 1=most important to 6=not as important. There is no right or wrong answer; it is up to patient preference, so no answer indicates a "better" than another.
measure: Decision Quality - Knowledge
time frame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
description: 27 questions assessing the participant's knowledge of treatment options for CHD. Participants not in the intervention arm will also take this survey for comparison. 21 of the questions use a dichotomous response format (either "true / false" or "yes/no"); 5 questions are multiple choice. All questions are answered with full access to the decision aid (if not in standard care arm) since participants are not meant to test recall. "Better" scores will be measured by how many questions that a participant answers correctly.
measure: Perinatal Grief
time frame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
description: Measured using the Perinatal Grief Scale which measures grief, coping, and despair following the death of a child. This scale was also adapted for a child who did not die. Answers are on a 5-point Likert scale that ranges from 1=strongly agree to 5=strongly disagree. A higher score would indicate less grief, and would therefore be considered "better".
measure: Brief Symptom Inventory (BSI) Global Severity Index of Global Distress
time frame: 1 week Post-Decision Aid, 1 month post-decision
description: The BSI is a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous seven days. Answers range in a 5 point Likert scale from 0=not at all to 4=extremely. The scale measures stress, so a lower score is better. Scores are obtained for nine primary symptom dimensions and three global indices of distress.
measure: Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE)
time frame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
description: COMRADE is validated patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. There are two sub-scales for risk communication and confidence in decision. It allows for paternalistic, shared or informed choice decision making models. There are 10 questions that are answered on a 5 point Likert scale ranging from 1-strongly disagree to 5=strongly agree. Higher scores are better, as they indicate a stronger understanding from the provider.
measure: Preference for Shared Decision Making
time frame: 1 week from Baseline, 1 week post-Decision Aid, & 1 month post-decision
description: This scale assesses participants' desire to participate in Shared Decision Making. It is an adaptation of the Degner & Sloan's Control Preference Scale. It is a one item question that asks people if they want to make the decision alone, with their clinician, or have their clinician make it. There is no right or wrong answer; it is up to patient preference, so no answer indicates a "better" than another.
measure: Preparation for Decision Making
time frame: 1 week Post-Decision Aid
description: Preparation for Decision Making Scale is a validated scale which will assess participants' perspectives of the decision aid's usefulness in preparing them to communicate with their clinicians and for Shared Decision Making. These questions are answered on a Likert scale ranging from 1=not at all to 5=a great deal. A higher score indicates that they are better prepared and, thus, a better outcome.
measure: Decision Self-Efficacy Scale
time frame: 1 week from Baseline, 1 week post-Decision Aid, & 1 month post-decision
description: 11 question survey that measures self-efficacy for performing informed decision making (e.g., getting needed information, asking questions, expressing opinions). Answers range in a 5 point Likert scale from 0=not at all confident to 4=extremely confident. Higher scores are better, as they indicate stronger self-efficacy.
measure: Decisional Conflict Scale
time frame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
description: A 16-question survey that measures 1) perceptions of uncertainty in choosing options, 2) feelings of having adequate knowledge and clear values, and 3) effective decision making. Answers range on a 5 point Likert scale from 0=strongly agree to 4=strongly disagree. Lower scores are better, as they indicate a stronger knowledge about choice availability.
measure: Decisional Regret
time frame: 3 months post-decision
description: Decision Regret will be assessed by asking participants to reflect on the decision they made about which treatment option they chose for their child. The measure consists of 5 items assessed on a 5-point Likert scale from "Strongly agree" to "Strongly disagree". There is no right or wrong answer; it is up to patient preference, so no answer indicates a "better" than another.
measure: Treatment Choice and Treatment Received
time frame: 1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision
description: Treatment Choice will be assessed by asking participants to identify which treatment they chose. Using electronic health records, we will record the child's actual treatment in case of parental change of mind or misreport. A "better" score would be matching the treatment choice declaration with whichever treatment the electronic health record indicates that the patient received.
measure: Control Preference Scale
time frame: 1 week post baseline, 1 week post decision aid, 1 month post-decision
description: This scale assesses participants' desire to participate in Shared Decision Making. This scale is an adaptation of the Degner & Sloan's Control Preference Scale. It is a one item question that asks people if they want to make the decision alone, with their clinician, or have their clinician make it. There is no right or wrong answer; it is up to patient preference, so no answer indicates a "better" than another.
measure: Acceptability of the Decision Aid
time frame: 1 week post decision aid
description: This will be assessed with 5 questions. Participants will be asked questions about if they used the decision aid (DA) before their appointment or during their appointment, their likelihood to recommend the DA, the amount of information presented, and if the DA seemed biased. There is no "better" or more correct answer; it is up to the patient's opinion.
measure: Consultation Quality
time frame: 1 week post baseline, 3 months post decision.
description: 2 items measuring the quality of consultation. One is asking the participant to rate their usefulness of consultation on a 7 point Likert scale that ranges from 0=not at all useful to 6=very useful. The second is asking the participant if the clinician encouraged any certain treatment. There is no "better" answer, as these are opinions.
measure: SF-12
time frame: 1 week post Baseline, 3 months post decision
description: The 12-Item Short Form Health Survey (SF-12) is a validated scale measuring the participant's health that was designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. Answers are given on a 5 point Likert scale ranging from 1=excellent to 5=poor for three of the questions (lower scores are better); answers are given in a dichotomous (yes/no) format for four of the questions ("yes" is better); answers are given on a 6 point Likert scale ranging from 1=all of the time to 6=none of the time for three of the questions (lower scores are better); answers are given in a trichotomous format (yes, limited a little; yes, limited a lot; no, not limited at all) for the remaining two questions ("no" is the better answer).
measure: Use of Information Sources
time frame: 1 week post decision aid
description: Participants indicate whether they consulted any of 10 sources of health information. Of these 10 sources, 2 ask about personal relationships (i.e., relatives and friends), 3 had their roots in massmedia (i.e., exposure to television/movies, magazines, and books about CHD), and 2 were educational/research-based (i.e., scientific journals/research papers and the internet). The remaining 3 sources included providers, support groups, and other parents who have a child with CHD. Answers are in a 5 point Likert scale ranging from 1=never to 5=a great deal. There is no right or wrong answer; it is up to patient preference, so no answer indicates a "better" than another.
measure: Impact of a Child with Congenital Anomalies on Parents
time frame: 1 month post decision, 3 months post decision
description: ICCAP is a validated questionnaire developed to assess the impact of giving birth to a child with severe anatomical congenital anomalies on parental quality of life as a result of early stress. There are 32 questions: 4 ask about contact with caregivers, 6 ask about support from social network, 5 ask about partner relationships, 4 ask about the participant's state of mind, and the remaining 13 ask about fear and anxiety. Answers range on a 4 point Likert scale that ranges from 1=strongly disagree to 4=strongly agree, with a "not applicable". With the first three categories (contact with caregivers, social network, and partner relationships), a higher score is a "better" score; the remaining two categories (state of mind and fear/anxiety) are reverse-scored, so a lower score is "better".
arm group label: Standard Care (Control)
arm group type: No Intervention
description: Participants will receive standard care and will not view either the Decision Aid or the Values Clarification Exercise
arm group label: Decision Aid
arm group type: Experimental
description: Participants view the Decision Aid only
arm group label: Decision Aid & Values Clarification Exercise
arm group type: Experimental
description: Participants view both the Decision Aid and the Values Clarification Exercise
intervention type: Other
intervention name: Decision Aid
description: Participants will view a Decision Aid (delivered as an app) that provides them with information regarding congenital heart disease, as described in the literature. The DA is tailored to the specific diagnosis of the fetus/neonate, so that participants are only viewing information about their baby's specific CHD diagnosis (and not other types of CHD). This is shown using videos and diagrams to clearly explain the defect, what their treatment options are (surgical intervention, comfort care, or termination), and personal stories from other parents who have dealt with the same diagnosis before (including both positive and negative outcomes). The DA was developed according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332).
arm group label: Decision Aid
arm group label: Decision Aid & Values Clarification Exercise
intervention type: Other
intervention name: Values Clarification Exercise
description: The Values Clarification Exercise is a process that aids patients in clarifying their values and goals to improve alignment of their preferences with their chosen treatment. It was developed according to the International Patient Decision Aid Standards. It includes ten values that were chosen based on feedback from the parent investigators and clinicians. The ten values are: 1) discomfort to the child, 2) time in the hospital, 3) risk that the child will have impairments, 4) need to provide home medical care, 5) chronic medical care/decisions, 6) financial issues, 7) life in adulthood, 8) impact on the family, 9) beliefs about doing everything medically possible, & 10) life expectancy. Each value has a sliding scale where the user can compare 2 treatment options at a time. They are asked which described situation feels better for them and their family.
arm group label: Decision Aid & Values Clarification Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Angela Fagerlin, PhD
role: Principal Investigator
affiliation: University of Utah
last name: Mandy Pershing, MS
phone: 801-587-2460
email: mandy.pershing@hsc.utah.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
citation: Ito M, Nakajima S, Fujisawa D, Miyashita M, Kim Y, Shear MK, Ghesquiere A, Wall MM. Brief measure for screening complicated grief: reliability and discriminant validity. PLoS One. 2012;7(2):e31209. doi: 10.1371/journal.pone.0031209. Epub 2012 Feb 14.
PMID: 22348057
citation: Prigerson HG, Maciejewski PK, Reynolds CF 3rd, Bierhals AJ, Newsom JT, Fasiczka A, Frank E, Doman J, Miller M. Inventory of Complicated Grief: a scale to measure maladaptive symptoms of loss. Psychiatry Res. 1995 Nov 29;59(1-2):65-79. doi: 10.1016/0165-1781(95)02757-2.
PMID: 8771222
citation: Toedter LJ, Lasker JN, Alhadeff JM. The Perinatal Grief Scale: development and initial validation. Am J Orthopsychiatry. 1988 Jul;58(3):435-49. doi: 10.1111/j.1939-0025.1988.tb01604.x.
PMID: 3407734
citation: Allen KA. Parental decision-making for medically complex infants and children: an integrated literature review. Int J Nurs Stud. 2014 Sep;51(9):1289-304. doi: 10.1016/j.ijnurstu.2014.02.003. Epub 2014 Feb 20.
PMID: 24636443
citation: Coulter A, Stilwell D, Kryworuchko J, Mullen PD, Ng CJ, van der Weijden T. A systematic development process for patient decision aids. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S2. doi: 10.1186/1472-6947-13-S2-S2. Epub 2013 Nov 29.
PMID: 24625093
citation: Fagerlin A, Pignone M, Abhyankar P, Col N, Feldman-Stewart D, Gavaruzzi T, Kryworuchko J, Levin CA, Pieterse AH, Reyna V, Stiggelbout A, Scherer LD, Wills C, Witteman HO. Clarifying values: an updated review. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S8. doi: 10.1186/1472-6947-13-S2-S8. Epub 2013 Nov 29.
PMID: 24625261
citation: Adams RC, Levy SE; COUNCIL ON CHILDREN WITH DISABILITIES. Shared Decision-Making and Children With Disabilities: Pathways to Consensus. Pediatrics. 2017 Jun;139(6):e20170956. doi: 10.1542/peds.2017-0956.
PMID: 28562298
citation: Neubauer K, Williams EP, Donohue PK, Boss RD. Communication and decision-making regarding children with critical cardiac disease: a systematic review of family preferences. Cardiol Young. 2018 Oct;28(10):1088-1092. doi: 10.1017/S1047951118001233. Epub 2018 Jul 31.
PMID: 30062980
citation: Kavanaugh K, Moro TT, Savage T, Mehendale R. Enacting a theory of caring to recruit and retain vulnerable participants for sensitive research. Res Nurs Health. 2006 Jun;29(3):244-52. doi: 10.1002/nur.20134.
PMID: 16676343
citation: Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
PMID: 19879711
citation: O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PMID: 7898294
citation: Zikmund-Fisher BJ, Smith DM, Ubel PA, Fagerlin A. Validation of the Subjective Numeracy Scale: effects of low numeracy on comprehension of risk communications and utility elicitations. Med Decis Making. 2007 Sep-Oct;27(5):663-71. doi: 10.1177/0272989X07303824. Epub 2007 Jul 24.
PMID: 17652180
citation: Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010 Jan;78(1):130-3. doi: 10.1016/j.pec.2009.05.012. Epub 2009 Jun 26.
PMID: 19560303
citation: Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
PMID: 12926578
citation: Fagerlin A, Zikmund-Fisher BJ, Ubel PA, Jankovic A, Derry HA, Smith DM. Measuring numeracy without a math test: development of the Subjective Numeracy Scale. Med Decis Making. 2007 Sep-Oct;27(5):672-80. doi: 10.1177/0272989X07304449. Epub 2007 Jul 19.
PMID: 17641137
citation: Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
PMID: 6622612
citation: Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.
PMID: 12900105
citation: Bekker HL, Hewison J, Thornton JG. Applying decision analysis to facilitate informed decision making about prenatal diagnosis for Down syndrome: a randomised controlled trial. Prenat Diagn. 2004 Apr;24(4):265-75. doi: 10.1002/pd.851.
PMID: 15065100
citation: Mazer P, Gischler SJ, Koot HM, Tibboel D, van Dijk M, Duivenvoorden HJ. Impact of a child with congenital anomalies on parents (ICCAP) questionnaire; a psychometric analysis. Health Qual Life Outcomes. 2008 Nov 23;6:102. doi: 10.1186/1477-7525-6-102.
PMID: 19025612
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Angie Fagerlin
investigator title: Professor & Chair, Department of Population Health Sciences
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No