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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

1 day

Results posted on

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

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

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 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=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

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

Condition 3: 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