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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

1 day

Results posted on

2026-04-22

Participant Flow

Participant milestones

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

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 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.

Outcome measures

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 day

Participants 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Combined 2: Stratified Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gretchen Chapman

Carnegie Mellon University

Phone: 412-268-3665

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place