Trial Outcomes & Findings for Don't Throw Your Heart Away: Medical Student Study 2 (NCT NCT04176796)
NCT ID: NCT04176796
Last Updated: 2024-10-29
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
105 participants
1 day
2024-10-29
Participant Flow
Recruited via email through medical school listserv.
Included if the participant identified as current medical student and was over 18.
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.
|
Condition 3: Stratified Only
Participants randomized to Condition 3 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
|
56
|
49
|
|
Overall Study
COMPLETED
|
56
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Don't Throw Your Heart Away: Medical Student Study 2
Baseline characteristics by cohort
| Measure |
Condition 1: Combined Only
n=56 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.
|
Condition 3: Stratified Only
n=49 Participants
Participants randomized to Condition 3 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=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
49 participants
n=7 Participants
|
105 participants
n=5 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=56 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.
|
Condition 3: Stratified Only
n=49 Participants
Participants randomized to Condition 3 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
|
33 Participants
|
47 Participants
|
|
Hospital Choice
Number choosing selective center
|
23 Participants
|
2 Participants
|
Adverse Events
Condition 1: Combined Only
Condition 3: 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