<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/NCT04455893</url>
  </required_header>
  <id_info>
    <org_study_id>1 F30 HL152526-01-C</org_study_id>
    <nct_id>NCT04455893</nct_id>
  </id_info>
  <brief_title>Don't Throw Your Heart Away: Clinician Study 3</brief_title>
  <official_title>Don't Throw Your Heart Away: Clinician Study 3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carnegie Mellon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carnegie Mellon University</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>
      Publicly available outcome assessments for transplant programs do not make salient that some&#xD;
      programs tend to reject many of the hearts they are offered, whereas other programs accept a&#xD;
      broader range of donor offers. The investigators use empirical studies to test whether&#xD;
      transplant center performance data (i.e. transplant and waitlist outcome statistics) that&#xD;
      reflect center donor acceptance rates influence laypersons to evaluate centers with high&#xD;
      organ decline rates less favorably than centers with low organ decline rates. 125 heart&#xD;
      transplant clinical personnel will be recruited from International Heart and Lung Society&#xD;
      (ISHLT) and the Pediatric Heart Transplant Society (PHTS) and randomized to one of two&#xD;
      different information presentation conditions. Participants will be asked to view the table&#xD;
      of transplant outcomes corresponding to the condition they were randomized to. Each&#xD;
      participant is asked to choose the hospital that they would consider to be&#xD;
      &quot;higher-performing&quot; between two hospitals: one hospital with a non-selective, &quot;accepting&quot;&#xD;
      strategy (takes all donor heart offers), and one hospital with a more selective,&#xD;
      &quot;cherrypicking&quot; strategy (tends to reject donor offers that are less than &quot;excellent&quot;&#xD;
      quality).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Publicly available outcome assessments for transplant programs do not make salient that some&#xD;
      programs tend to reject many of the hearts they are offered, whereas other programs accept a&#xD;
      broader range of donor offers. The investigators use empirical studies to test whether&#xD;
      transplant center performance data (i.e. transplant and waitlist outcome statistics) that&#xD;
      reflect center donor acceptance rates influence laypersons to evaluate centers with high&#xD;
      organ decline rates less favorably than centers with low organ decline rates. 125 heart&#xD;
      transplant clinical personnel will be recruited from International Heart and Lung Society&#xD;
      (ISHLT) and the Pediatric Heart Transplant Society (PHTS) and randomized to one of two&#xD;
      different information presentation conditions. Participants will be asked to view the table&#xD;
      of transplant outcomes corresponding to the condition they were randomized to. Each&#xD;
      participant is asked to choose the hospital that they would consider to be&#xD;
      &quot;higher-performing&quot; between two hospitals: one hospital with a non-selective, &quot;accepting&quot;&#xD;
      strategy (takes all donor heart offers), and one hospital with a more selective,&#xD;
      &quot;cherrypicking&quot; strategy (tends to reject donor offers that are less than &quot;excellent&quot;&#xD;
      quality).&#xD;
&#xD;
      Condition 1 (&quot;baseline&quot; condition): view only combined transplant survival (e.g. transplant&#xD;
      survival rate not stratified by number and quality of donor hearts accepted at each center)&#xD;
&#xD;
      Condition 2: view only stratified transplant survival (e.g. transplant survival rate&#xD;
      stratified into patients who received excellent donor organs and patients who received less&#xD;
      than optimal donor organs)&#xD;
&#xD;
      Participants will then be asked to view the table of transplant outcomes corresponding to the&#xD;
      condition they were randomized to. Each participant is asked to choose the hospital that they&#xD;
      would consider to be &quot;higher-performing&quot; between two hospitals: one hospital with a&#xD;
      non-selective, &quot;accepting&quot; strategy (takes all donor heart offers), and one hospital with a&#xD;
      more selective, &quot;cherry-picking&quot; strategy (tends to reject donor offers that are less than&#xD;
      &quot;excellent&quot; quality). In order to identify the decision process that underlies this choice&#xD;
      pattern, the investigators will examine a putative mediator. Specifically, participants will&#xD;
      be asked to rate the extent to which they considered patients' chances of getting an&#xD;
      excellent heart, avoiding a less-than-optimal heart, and getting any type of heart when&#xD;
      making their choice between the two hospitals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Choice</measure>
    <time_frame>1 day</time_frame>
    <description>The outcome variable will be a measure of binary choice between two hospitals: one with a selective donor-heart acceptance strategy and one with a non-selective donor heart acceptance strategy.&#xD;
Participants will respond to the question &quot;Which Hospital is a better choice for patients? Please click on one of the two tables below to indicate which hospital is the better choice.&quot; Participants will choose been two outcome tables featuring the selective and non-selective hospital (counterbalanced, such that each of the two choices is equally likely to be presented at top of the choice scenario in each condition). The number of participants that choose each hospital will be the measured outcome variable used in analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mediator of Hospital Choice</measure>
    <time_frame>1 day</time_frame>
    <description>On the next page of the survey, participants will respond to three mediator questions: &quot;There are many reasons why one transplant hospital might outperform another. Which reasons were most important in your decision? Please move the slider to indicate how much you considered each of the reasons below (0=reason was not important, 100=reason was extremely important).&quot;&#xD;
Participants will then move a slider bar (0-100) to indicate the importance of the following three items:&#xD;
Patients were more likely to receive an excellent donor heart at the hospital I picked.&#xD;
Patients were less likely to receive a marginal donor heart at the hospital I picked.&#xD;
Patients were more likely to receive any kind of heart at the hospital I picked.&#xD;
The third item (more likely to receive any kind of heart) will be the only variable that is included in the planned mediation analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Cardiac Transplant Disorder</condition>
  <arm_group>
    <arm_group_label>Condition 1: Combined only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined 2: Stratified only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stratified Transplant Survival</intervention_name>
    <description>The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = [number of patients surviving after transplant with excellent organ]/[number of patients for whom excellent organ was accepted for transplant] marginal transplant survival = [number of patients surviving after transplant with marginal organ]/[number of patients for whom marginal organ was accepted for transplant]</description>
    <arm_group_label>Combined 2: Stratified only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants will be asked to participate if they confirm the following inclusion criteria&#xD;
        in the consent form.&#xD;
&#xD;
          1. 18 years of age or older&#xD;
&#xD;
          2. must read and understand the information in the consent form&#xD;
&#xD;
          3. must want to participate in the research and continue with the survey&#xD;
&#xD;
          4. must be clinical transplant personnel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. participants who do not meet primary criterion of being clinical transplant personnel.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison E Butler, BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carnegie Mellon University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carnegie Mellon University</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carnegie Mellon University</investigator_affiliation>
    <investigator_full_name>Gretchen Chapman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Heart Transplant</keyword>
  <keyword>Transplant Survival</keyword>
  <keyword>Applied Ethics</keyword>
  <keyword>Medical Student</keyword>
  <keyword>Human Behavior</keyword>
  <keyword>Decision Psychology</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The PI will make all of the raw IPD files - together with statistical analysis protocol descriptions and information for proper analysis available for download a minimum of 1 year, and a maximum of 3 years, after publication of the corresponding manuscripts. All human subjects data are anonymized immediately when they are initially written from the online survey platform to the server, and thus participant confidentiality will not be compromised by this plan for data sharing.&#xD;
All hypotheses, methods, and planned analyses for the applicant's studies will be pre-registered on ClinicalTrials.gov and Open Science Framework.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>All of the raw files, statistical analysis protocol descriptions, and information for proper analysis will be available for download a minimum of 1 year, and a maximum of 3 years, after publication of the corresponding manuscripts.</ipd_time_frame>
    <ipd_url>https://osf.io/xe92f/</ipd_url>
  </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/NCT04455893
org study id: 1 F30 HL152526-01-C
nct id: NCT04455893
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Publicly available outcome assessments for transplant programs do not make salient that some
      programs tend to reject many of the hearts they are offered, whereas other programs accept a
      broader range of donor offers. The investigators use empirical studies to test whether
      transplant center performance data (i.e. transplant and waitlist outcome statistics) that
      reflect center donor acceptance rates influence laypersons to evaluate centers with high
      organ decline rates less favorably than centers with low organ decline rates. 125 heart
      transplant clinical personnel will be recruited from International Heart and Lung Society
      (ISHLT) and the Pediatric Heart Transplant Society (PHTS) and randomized to one of two
      different information presentation conditions. Participants will be asked to view the table
      of transplant outcomes corresponding to the condition they were randomized to. Each
      participant is asked to choose the hospital that they would consider to be
      "higher-performing" between two hospitals: one hospital with a non-selective, "accepting"
      strategy (takes all donor heart offers), and one hospital with a more selective,
      "cherrypicking" strategy (tends to reject donor offers that are less than "excellent"
      quality).
Publicly available outcome assessments for transplant programs do not make salient that some
      programs tend to reject many of the hearts they are offered, whereas other programs accept a
      broader range of donor offers. The investigators use empirical studies to test whether
      transplant center performance data (i.e. transplant and waitlist outcome statistics) that
      reflect center donor acceptance rates influence laypersons to evaluate centers with high
      organ decline rates less favorably than centers with low organ decline rates. 125 heart
      transplant clinical personnel will be recruited from International Heart and Lung Society
      (ISHLT) and the Pediatric Heart Transplant Society (PHTS) and randomized to one of two
      different information presentation conditions. Participants will be asked to view the table
      of transplant outcomes corresponding to the condition they were randomized to. Each
      participant is asked to choose the hospital that they would consider to be
      "higher-performing" between two hospitals: one hospital with a non-selective, "accepting"
      strategy (takes all donor heart offers), and one hospital with a more selective,
      "cherrypicking" strategy (tends to reject donor offers that are less than "excellent"
      quality).

      Condition 1 ("baseline" condition): view only combined transplant survival (e.g. transplant
      survival rate not stratified by number and quality of donor hearts accepted at each center)

      Condition 2: view only stratified transplant survival (e.g. transplant survival rate
      stratified into patients who received excellent donor organs and patients who received less
      than optimal donor organs)

      Participants will then be asked to view the table of transplant outcomes corresponding to the
      condition they were randomized to. Each participant is asked to choose the hospital that they
      would consider to be "higher-performing" between two hospitals: one hospital with a
      non-selective, "accepting" strategy (takes all donor heart offers), and one hospital with a
      more selective, "cherry-picking" strategy (tends to reject donor offers that are less than
      "excellent" quality). In order to identify the decision process that underlies this choice
      pattern, the investigators will examine a putative mediator. Specifically, participants will
      be asked to rate the extent to which they considered patients' chances of getting an
      excellent heart, avoiding a less-than-optimal heart, and getting any type of heart when
      making their choice between the two hospitals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Hospital Choice
time frame: 1 day
description: The outcome variable will be a measure of binary choice between two hospitals: one with a selective donor-heart acceptance strategy and one with a non-selective donor heart acceptance strategy.
Participants will respond to the question "Which Hospital is a better choice for patients? Please click on one of the two tables below to indicate which hospital is the better choice." Participants will choose been two outcome tables featuring the selective and non-selective hospital (counterbalanced, such that each of the two choices is equally likely to be presented at top of the choice scenario in each condition). The number of participants that choose each hospital will be the measured outcome variable used in analyses.
measure: Mediator of Hospital Choice
time frame: 1 day
description: On the next page of the survey, participants will respond to three mediator questions: "There are many reasons why one transplant hospital might outperform another. Which reasons were most important in your decision? Please move the slider to indicate how much you considered each of the reasons below (0=reason was not important, 100=reason was extremely important)."
Participants will then move a slider bar (0-100) to indicate the importance of the following three items:
Patients were more likely to receive an excellent donor heart at the hospital I picked.
Patients were less likely to receive a marginal donor heart at the hospital I picked.
Patients were more likely to receive any kind of heart at the hospital I picked.
The third item (more likely to receive any kind of heart) will be the only variable that is included in the planned mediation analysis.
arm group label: Condition 1: Combined only
arm group type: No Intervention
description: Participants randomized to baseline (control) arm Condition 1 will view only combined transplant survival outcome information (e.g. transplant survival rate not stratified by number and quality of donor hearts accepted at each center) when making a choice between the two hospitals.
arm group label: Combined 2: Stratified only
arm group type: Experimental
description: Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals.
intervention type: Other
intervention name: Stratified Transplant Survival
description: The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = [number of patients surviving after transplant with excellent organ]/[number of patients for whom excellent organ was accepted for transplant] marginal transplant survival = [number of patients surviving after transplant with marginal organ]/[number of patients for whom marginal organ was accepted for transplant]
arm group label: Combined 2: Stratified only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alison E Butler, BS
role: Principal Investigator
affiliation: Carnegie Mellon University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Carnegie Mellon University
investigator full name: Gretchen Chapman
investigator title: Professor
sharing ipd: Yes
ipd description: The PI will make all of the raw IPD files - together with statistical analysis protocol descriptions and information for proper analysis available for download a minimum of 1 year, and a maximum of 3 years, after publication of the corresponding manuscripts. All human subjects data are anonymized immediately when they are initially written from the online survey platform to the server, and thus participant confidentiality will not be compromised by this plan for data sharing.
All hypotheses, methods, and planned analyses for the applicant's studies will be pre-registered on ClinicalTrials.gov and Open Science Framework.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: All of the raw files, statistical analysis protocol descriptions, and information for proper analysis will be available for download a minimum of 1 year, and a maximum of 3 years, after publication of the corresponding manuscripts.
ipd url: https://osf.io/xe92f/