Trial Outcomes & Findings for Don't Throw Your Heart Away: Clinician Study 3 (NCT NCT04455893)
NCT ID: NCT04455893
Last Updated: 2026-04-22
Results Overview
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.
COMPLETED
NA
72 participants
1 day
2026-04-22
Participant Flow
Participant milestones
| Measure |
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.
|
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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
34
|
|
Overall Study
COMPLETED
|
38
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measure in row does not differ
Baseline characteristics by cohort
| Measure |
Condition 1: Combined Only
n=38 Participants
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.
|
Combined 2: Stratified Only
n=34 Participants
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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=60 Participants
|
33 Participants
n=56 Participants
|
70 Participants
n=116 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
2 Participants
n=116 Participants
|
|
Age, Continuous
|
46 years
n=60 Participants • Measure in row does not differ
|
46 years
n=56 Participants • Measure in row does not differ
|
46 years
n=116 Participants • Measure in row does not differ
|
|
Sex: Female, Male
Female
|
11 Participants
n=60 Participants
|
12 Participants
n=56 Participants
|
23 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=60 Participants
|
22 Participants
n=56 Participants
|
49 Participants
n=116 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=60 Participants
|
29 Participants
n=56 Participants
|
62 Participants
n=116 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=60 Participants
|
5 Participants
n=56 Participants
|
8 Participants
n=116 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=60 Participants
|
34 Participants
n=56 Participants
|
72 Participants
n=116 Participants
|
PRIMARY outcome
Timeframe: 1 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.
Outcome measures
| Measure |
Condition 1: Combined Only
n=38 Participants
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.
|
Combined 2: Stratified Only
n=34 Participants
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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]
|
|---|---|---|
|
Hospital Choice
Number choosing non-selective center
|
4 Participants
|
21 Participants
|
|
Hospital Choice
Number choosing selective center
|
34 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 1 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
Outcome measures
| Measure |
Condition 1: Combined Only
n=37 Participants
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.
|
Combined 2: Stratified Only
n=31 Participants
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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]
|
|---|---|---|
|
Mediator of Hospital Choice
|
44.27 score on a scale
Standard Deviation 26.72
|
58.93 score on a scale
Standard Deviation 29.65
|
Adverse Events
Condition 1: Combined Only
Combined 2: Stratified Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place