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Don't Throw Your Heart Away: Clinician Study 3

Don't Throw Your Heart Away: Clinician Study 3

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04455893
Enrollment
72
Registered
2020-07-02
Start date
2020-06-30
Completion date
2020-10-31
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Transplant Disorder

Keywords

Heart Transplant, Transplant Survival, Applied Ethics, Medical Student, Human Behavior, Decision Psychology

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. 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).

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.

Interventions

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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]

Sponsors

Carnegie Mellon University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Hospital Choice1 dayThe 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

MeasureTime frameDescription
Mediator of Hospital Choice1 dayParticipants were asked, "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). Patients were more likely to receive any type of donor heart at the hospital I picked." The reported data show the mean rating on a 0 to 100 scale

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlison E Butler, BS

Carnegie Mellon University

Participant flow

Participants by arm

ArmCount
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.
38
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. 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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]
34
Total72

Baseline characteristics

CharacteristicCondition 1: Combined OnlyCombined 2: Stratified OnlyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants1 Participants2 Participants
Age, Categorical
Between 18 and 65 years
37 Participants33 Participants70 Participants
Age, Continuous46 years46 years46 years
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants5 Participants8 Participants
Race (NIH/OMB)
White
33 Participants29 Participants62 Participants
Region of Enrollment
United States
38 Participants34 Participants72 Participants
Sex: Female, Male
Female
11 Participants12 Participants23 Participants
Sex: Female, Male
Male
27 Participants22 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 38
other
Total, other adverse events
0 / 380 / 34
serious
Total, serious adverse events
0 / 380 / 34

Outcome results

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.

Time frame: 1 day

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Condition 1: Combined OnlyHospital ChoiceNumber choosing non-selective center4 Participants
Condition 1: Combined OnlyHospital ChoiceNumber choosing selective center34 Participants
Combined 2: Stratified OnlyHospital ChoiceNumber choosing non-selective center21 Participants
Combined 2: Stratified OnlyHospital ChoiceNumber choosing selective center13 Participants

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026