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Don't Throw Your Heart Away: Layperson Study 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133831
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Gretchen Chapman, Carnegie Mellon University

Brief 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).

Condition or disease Intervention/treatment Phase
Cardiac Transplant Disorder Other: Total Survival Other: Stratified Transplant Survival Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Don't Throw Your Heart Away: Layperson Study 1
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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: Condition 2: Combined plus Total
Participants randomized to Condition 2 will view combined transplant survival and total survival outcome information when making a choice between the two hospitals.
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].


Experimental: Condition 3: Stratified only
Participants randomized to Condition 3 will view only stratified transplant survival outcome information when making a choice between the two hospitals.
Other: 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]


Experimental: Condition 4: Stratified plus Total
Participants randomized to Condition 4 will view stratified transplant survival and total survival outcome information when making a choice between the two hospitals.
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].


Other: 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]


Experimental: Condition 5: Total only
Participants randomized to Condition 5 will view only total survival outcome information when making a choice between the two hospitals.
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].





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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:

    1. Patients were more likely to receive an excellent donor heart at the hospital I picked.
    2. Patients were less likely to receive a marginal donor heart at the hospital I picked.
    3. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133831


Contacts
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Contact: Alison E Butler, BS 2699039311 abutler2@andrew.cmu.edu
Contact: Gretchen Chapman, PhD gchapman@andrew.cmu.edu

Sponsors and Collaborators
Carnegie Mellon University
Investigators
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Principal Investigator: Alison E Butler, BS Carnegie Mellon University

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Responsible Party: Gretchen Chapman, Professor, Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT04133831    
Other Study ID Numbers: 1 F30 HL152526-01-A
20PRE35120492 ( Other Grant/Funding Number: American Heart Association )
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
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.
URL: https://osf.io/9fsb3/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gretchen Chapman, Carnegie Mellon University:
Heart Transplant
Transplant Survival
Applied Ethics
Decision Psychology
Human Behavior