Don't Throw Your Heart Away: Layperson Study 1

Cardiac Transplant Disorder Clinical Trial

Official title:

Don't Throw Your Heart Away: Layperson Study 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133831
• Other study ID #: 1 F30 HL152526-01-A
• Secondary ID: 20PRE35120492
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2020
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. 1000 lay participants will be recruited from Amazon Mechanical Turk and randomized to one of five different information presentation conditions. Participants will be given an introduction to the donor organ match process, then asked to view the table of transplant outcomes corresponding to the condition they were randomized to. Each participant is asked to choose between two hospitals: one hospital with an 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).

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. 1000 lay participants will be recruited from Amazon Mechanical Turk and randomized to one of five different information presentation conditions:

1. 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)

2. Condition 2: view combined transplant survival + total survival (e.g. overall survival rate at each center, computed from survival rates of both transplant and waitlist patients)

3. Condition 3: 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)

4. Condition 4: view stratified transplant survival + total survival

5. Condition 5: view only total survival

Participants will be given an introduction to the donor organ match process, then asked to view the table of transplant outcomes corresponding to the condition they were randomized to. Each participant is asked to choose between two hospitals: one hospital with an 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1048
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Participants who are already qualified mTurk workers with Worker Accounts meeting the above criteria 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 live in United States

Exclusion Criteria:

1. Participants on mTurk will not be allowed to participate if they fail to pass the initial "bot screening", a multiple-choice question that asks, "What phone number should you dial when there is an emergency?" The obvious correct response in this screening question is "911", so participants who select one of the incorrect responses (i.e. "1-800-ANTIBOT", "1-877-MTURKER", "123") are filtered out and not allowed to complete the survey.

2. Participants on mTurk will be allowed to participate, but excluded from data analysis, if they submit a nonsense response to the free-response question which reads, "In your own words, why do you think patients should choose the hospital you picked?" This question takes place after the participant has viewed the choice stimuli and selected their response. If participants input nonsense in the text response box, they will be permitted to complete the survey and paid, but filtered out from the data analysis.

Related Conditions & MeSH terms

• Cardiac Transplant Disorder

Intervention

Other:
• Total Survival
The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: [(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)] / [number of patients alive on waitlist at start of year].
• Stratified Transplant Survival
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]

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Carnegie Mellon University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Choice	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	Mediator of Hospital Choice	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