- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04809051
Don't Throw Your Heart Away: Patient Study 4
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alison E Butler, MS
- Phone Number: 2699039311
- Email: abutler2@andrew.cmu.edu
Study Contact Backup
- Name: Gretchen Chapman, PhD
- Email: gchapman@andrew.cmu.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Carnegie Mellon University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants will be asked to participate if they confirm the following inclusion criteria in the consent form.
- 18 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
Exclusion Criteria:
Participants who do not meet the primary criterion of being a pre- or post-transplant patient or family member of the transplant patient.
Study Plan
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 Transplant Pictograph
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.
|
|
Experimental: Condition 2: Stratified Transplant Pictograph
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.
|
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.
|
Experimental: Condition 3: Combined Transplant SRTR
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.
|
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.
|
Experimental: Condition 4: Stratified Transplant SRTR
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.
|
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.
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.
|
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 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 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
Sponsor
Investigators
- Principal Investigator: Alison E Butler, MS, Carnegie Mellon University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 F30 HL152526-01-D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Yes 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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