Trial Outcomes & Findings for Don't Throw Your Heart Away: Layperson Study 1 (NCT NCT04133831)

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

1019 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.	Condition 2: Combined Plus Total Participants randomized to Condition 2 will view combined transplant survival and total survival outcome information when making a choice between the two hospitals. Total Survival: The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: \[(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)\] / \[number of patients alive on waitlist at start of year\].	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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]	Condition 4: Stratified Plus Total Participants randomized to Condition 4 will view stratified transplant survival and total survival outcome information when making a choice between the two hospitals. Total Survival: The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: \[(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)\] / \[number of patients alive on waitlist at start of year\]. 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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]	Condition 5: Total Only Participants randomized to Condition 5 will view only total survival outcome information when making a choice between the two hospitals. Total Survival: The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: \[(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)\] / \[number of patients alive on waitlist at start of year\].
Overall Study STARTED	183	194	192	209	241
Overall Study COMPLETED	183	194	192	209	241
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Don't Throw Your Heart Away: Layperson Study 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Condition 1: Combined Only n=183 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 2: Combined Plus Total n=194 Participants Participants randomized to Condition 2 will view combined transplant survival and total survival outcome information when making a choice between the two hospitals. Total Survival: The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: \[(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)\] / \[number of patients alive on waitlist at start of year\].	Condition 3: Stratified Only n=192 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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]	Condition 4: Stratified Plus Total n=209 Participants Participants randomized to Condition 4 will view stratified transplant survival and total survival outcome information when making a choice between the two hospitals. Total Survival: The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: \[(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)\] / \[number of patients alive on waitlist at start of year\]. 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 = \[number of patients surviving after transplant with marginal organ\]/\[number of patients for whom marginal organ was accepted for transplant\]	Condition 5: Total Only n=241 Participants Participants randomized to Condition 5 will view only total survival outcome information when making a choice between the two hospitals. Total Survival: The overall or "total" survival rate at each center is displayed in the table of outcome statistics. Total survival is computed from survival rates of both transplant and waitlist patients: \[(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)\] / \[number of patients alive on waitlist at start of year\].	Total n=1019 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	181 Participants n=5 Participants	192 Participants n=7 Participants	190 Participants n=5 Participants	207 Participants n=4 Participants	239 Participants n=21 Participants	1009 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	9 Participants n=8 Participants
Sex/Gender, Customized Sex/Gender (customized) · Female	82 Participants n=5 Participants	97 Participants n=7 Participants	87 Participants n=5 Participants	102 Participants n=4 Participants	119 Participants n=21 Participants	487 Participants n=8 Participants
Sex/Gender, Customized Sex/Gender (customized) · Male	97 Participants n=5 Participants	90 Participants n=7 Participants	96 Participants n=5 Participants	106 Participants n=4 Participants	115 Participants n=21 Participants	504 Participants n=8 Participants
Sex/Gender, Customized Sex/Gender (customized) · Unknown/Other	4 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants	28 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=8 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	11 Participants n=21 Participants	48 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	19 Participants n=4 Participants	16 Participants n=21 Participants	72 Participants n=8 Participants
Race (NIH/OMB) White	142 Participants n=5 Participants	154 Participants n=7 Participants	141 Participants n=5 Participants	157 Participants n=4 Participants	190 Participants n=21 Participants	784 Participants n=8 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	13 Participants n=21 Participants	49 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants	12 Participants n=4 Participants	10 Participants n=21 Participants	58 Participants n=8 Participants
Region of Enrollment United States	183 participants n=5 Participants	194 participants n=7 Participants	192 participants n=5 Participants	209 participants n=4 Participants	241 participants n=21 Participants	1019 participants n=8 Participants

PRIMARY outcome

Timeframe: 1 day