Don't Throw Your Heart Away: Patient Study 4

NCT04809051 | Completed

• 2 other identifiers: 1 F30 HL152526-01-D1F30HL152526-01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This empirical study tests whether transplant center performance data that reflect center donor acceptance rates influence patients and their family members to evaluate centers with high organ decline rates less favorably than centers with low organ decline rates. 400 transplant patients and family members will be recruited from transplant support group social media websites and randomized to one of four different information presentation conditions. Upon viewing a pair of outcome tables corresponding to their condition, the participants are asked to choose which hospital is higher performing (one hospital with a non-selective "accepting" strategy and one hospital with a more selective "cherrypicking" strategy.

Conditions

Cardiac Transplant Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 higher performing? 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 Outcomes (1)

• Mediator of Hospital Choice

  1 day

Study Arms (4)

Condition 1: Combined Transplant Pictograph

NO INTERVENTION

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. The "survival following transplant" metric is displayed as a survival rate pictograph corresponding to all patients at the center who received transplants.

Condition 2: Stratified Transplant Pictograph

EXPERIMENTAL

Participants randomized to Condition 2 will view only stratified transplant survival outcome information when making a choice between the two hospitals. The "survival following transplant" metric is displayed as a pair of survival rate pictographs corresponding to two distinct groups of transplant patients at the center: those who received optimal donor organs and those who received adequate donor organs.

Other: Stratified Transplant Survival Metric

Condition 3: Combined Transplant SRTR

EXPERIMENTAL

Participants randomized to Condition 3 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. The "survival following transplant" metric is displayed as a quintile score corresponding to all patients at the center who received transplants.

Other: SRTR Information Format

Condition 4: Stratified Transplant SRTR

EXPERIMENTAL

Participants randomized to Condition 4 will view only stratified transplant survival outcome information when making a choice between the two hospitals. The "survival following transplant" metric is displayed as a pair of quintile scores corresponding to two distinct groups of transplant patients at the center: those who received optimal donor organs and those who received adequate donor organs.

Other: Stratified Transplant Survival Metric; Other: SRTR Information Format

Interventions

Stratified Transplant Survival Metric OTHER

Both transplant metric conditions display the number of hearts offered to each center, the number of hearts accepted by each center, and the number of transplants performed at each center (in a year), in addition to the condition-specific metrics below. The stratified condition instead features a pair of values corresponding to each center's offers/acceptances/transplant survival rates for donor hearts of "optimal" or "adequate" quality.

Condition 2: Stratified Transplant Pictograph; Condition 4: Stratified Transplant SRTR

SRTR Information Format OTHER

The information format varies based on how the transplant hospital statistics are organized when presented to participants on the choice screen. The SRTR conditions mimic the information format present on the SRTR public reporting website.

Condition 3: Combined Transplant SRTR; Condition 4: Stratified Transplant SRTR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• must read and understand the information in the consent form
• must want to participate in the research and continue with the survey
• must be a pre- or post-transplant patient or family member of the transplant patient

You may not qualify if:

• Participants who do not meet the primary criterion of being a pre- or post-transplant patient or family member of the transplant patient.

Sponsors & Collaborators

• Carnegie Mellon University: lead

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Alison E Butler, MS

  Carnegie Mellon University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: April 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)