Don't Throw Your Heart Away: Clinician Study 3

February 10, 2021 updated by: Gretchen Chapman, Carnegie Mellon University
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).

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Carnegie Mellon University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants will be asked to participate if they confirm the following inclusion criteria in the consent form.

  1. 18 years of age or older
  2. must read and understand the information in the consent form
  3. must want to participate in the research and continue with the survey
  4. must be clinical transplant personnel

Exclusion Criteria:

1. participants who do not meet primary criterion of being clinical transplant personnel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Condition 1: Combined only
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.
Experimental: Combined 2: Stratified only
Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals.
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]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Choice
Time Frame: 1 day

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.

1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mediator of Hospital Choice
Time Frame: 1 day

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.

1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alison E Butler, BS, Carnegie Mellon University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan 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 Sharing 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 Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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