Trial Outcomes & Findings for Don't Throw Your Heart Away: Clinician Study 3 (NCT NCT04455893)

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

Target enrollment

72 participants

Primary outcome timeframe

1 day

Results posted on

2024-10-29

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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	46 years n=5 Participants • Measure in row does not differ	46 years n=7 Participants • Measure in row does not differ	46 years n=5 Participants • Measure in row does not differ
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

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

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place