Trial Outcomes & Findings for Creating a Patient-centered Report Card for Solid Organ Transplant Candidates (NCT NCT03610555)
NCT ID: NCT03610555
Last Updated: 2025-12-16
Results Overview
The primary outcome is the comprehension of the report card. To assess comprehension, the correct response to the following question will be assessed, "Which transplant program within a prespecified area had the most recipients over 70 years of age; and which programs had the most recipients with BMI \>40"
COMPLETED
NA
268 participants
30 minutes
2025-12-16
Participant Flow
Adults (age 18+) were recruited to participate from the waiting list or in the process of being evaluated for deceased donor kidney transplants at two urban transplant programs in the Midwest. Patients were approached by mail with follow-up via a phone call with an institutional review board-approved script for attaining consent and conducting the intervention.
A total of (n=6) were excluded from the study. Reasons for exclusion include the following: Not meeting exclusion criteria (n=1) and excluded since part of vanguard study (n=5).
Participant milestones
| Measure |
Arm 1: Sequence1
Participants first viewed the SRTR website to answer Question 1 (Which transplant program within a prespecified area had the most recipients over 70 years of age?). Subsequently, participants crossed over to view the TCST website to answer Question 2 (Which program within a prespecified area had the most recipients with BMI \>40?).
|
Arm 2: Sequence2
Participants first viewed the SRTR website to answer Question 2. Subsequently, participants crossed over to view the TCST website to answer Question 1.
|
Arm 3: Sequence3
Participants first viewed the TCST website to answer Question 1. Subsequently, participants crossed over to view the SRTR website to answer Question 2.
|
Arm 4: Sequence4
Participants first viewed the TCST website to answer Question 2. Subsequently, participants crossed over to view the SRTR website to answer Question 1.
|
|---|---|---|---|---|
|
Initial Randomization
STARTED
|
12
|
19
|
18
|
19
|
|
Initial Randomization
COMPLETED
|
12
|
19
|
18
|
19
|
|
Initial Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Crossover to 2nd Website and Question
STARTED
|
12
|
19
|
18
|
19
|
|
Crossover to 2nd Website and Question
COMPLETED
|
12
|
18
|
17
|
19
|
|
Crossover to 2nd Website and Question
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Sequence1
Participants first viewed the SRTR website to answer Question 1 (Which transplant program within a prespecified area had the most recipients over 70 years of age?). Subsequently, participants crossed over to view the TCST website to answer Question 2 (Which program within a prespecified area had the most recipients with BMI \>40?).
|
Arm 2: Sequence2
Participants first viewed the SRTR website to answer Question 2. Subsequently, participants crossed over to view the TCST website to answer Question 1.
|
Arm 3: Sequence3
Participants first viewed the TCST website to answer Question 1. Subsequently, participants crossed over to view the SRTR website to answer Question 2.
|
Arm 4: Sequence4
Participants first viewed the TCST website to answer Question 2. Subsequently, participants crossed over to view the SRTR website to answer Question 1.
|
|---|---|---|---|---|
|
Crossover to 2nd Website and Question
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Creating a Patient-centered Report Card for Solid Organ Transplant Candidates
Baseline characteristics by cohort
| Measure |
Arm 1: SRTR Website First, Question 1 First
n=12 Participants
Show patient SRTRT website first, then question 1 first
|
Arm 2: SRTR Website First, Question 2 First
n=19 Participants
Show patient SRTRT website first, then question 2 first
|
Arm 3: TCST First, Question 1 First
n=18 Participants
Show patient TCST website first, then question 1 first.
|
Arm 4: TCST First, Question 2 First
n=19 Participants
Show patient TCST website first, then question 2 first.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
6 Participants
n=205 Participants
|
28 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
13 Participants
n=205 Participants
|
40 Participants
n=16 Participants
|
|
Education Level
Less than high school
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
2 Participants
n=16 Participants
|
|
Education Level
High School
|
2 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
15 Participants
n=16 Participants
|
|
Education Level
Some college
|
4 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
4 Participants
n=205 Participants
|
18 Participants
n=16 Participants
|
|
Education Level
More than college (e.g. M.A., PHD, MD)
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=205 Participants
|
17 Participants
n=16 Participants
|
|
Education Level
College
|
5 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
6 Participants
n=205 Participants
|
16 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · Non-Hispanic White
|
9 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
12 Participants
n=9 Participants
|
17 Participants
n=205 Participants
|
49 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
3 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
14 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
5 Participants
n=16 Participants
|
|
Single Item Literacy Scale (score >2)
Yes
|
0 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
11 Participants
n=16 Participants
|
|
Single Item Literacy Scale (score >2)
No
|
12 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
17 Participants
n=205 Participants
|
57 Participants
n=16 Participants
|
|
Single Item Literacy Scale (mean)
|
1.33 Score on a scale
STANDARD_DEVIATION 0.49 • n=9 Participants
|
1.84 Score on a scale
STANDARD_DEVIATION 1.01 • n=6 Participants
|
1.39 Score on a scale
STANDARD_DEVIATION 0.78 • n=9 Participants
|
1.47 Score on a scale
STANDARD_DEVIATION 0.84 • n=205 Participants
|
1.53 Score on a scale
STANDARD_DEVIATION 0.84 • n=16 Participants
|
|
Age, Customized
Age · <50 years
|
1 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
6 Participants
n=205 Participants
|
14 Participants
n=16 Participants
|
|
Age, Customized
Age · 50 < 65 years
|
3 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
8 Participants
n=205 Participants
|
31 Participants
n=16 Participants
|
|
Age, Customized
Age · 65+ years
|
7 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
5 Participants
n=205 Participants
|
22 Participants
n=16 Participants
|
|
Age, Customized
Age · Missing
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Latino
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=205 Participants
|
5 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Latino
|
12 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
15 Participants
n=205 Participants
|
62 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
1 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: To assess comprehension, the correct response to the following question will be assessed, "Which transplant program within a prespecified area had the most recipients over 70 years of age; and which programs had the most recipients with BMI \>40"
The primary outcome is the comprehension of the report card. To assess comprehension, the correct response to the following question will be assessed, "Which transplant program within a prespecified area had the most recipients over 70 years of age; and which programs had the most recipients with BMI \>40"
Outcome measures
| Measure |
Arm 1: SRTR Website First, Question 1 First
n=12 Participants
Show patient SRTRT website first, then question 1 first
|
Arm 2: SRTR Website First, Question 2 First
n=18 Participants
Show patient SRTRT website first, then question 2 first
|
Arm 3: TCST First, Question 1 First
n=18 Participants
Show patient TCST website first, then question 1 first.
|
Arm 4: TCST First, Question 2 First
n=19 Participants
Show patient TCST website first, then question 2 first.
|
|---|---|---|---|---|
|
Number of Participants With Correct Response to Question 1 and 2
Comprehension : Question 2 - BMI
|
12 Participants
|
17 Participants
|
16 Participants
|
18 Participants
|
|
Number of Participants With Correct Response to Question 1 and 2
Missing : Question 1 - age over 70
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Correct Response to Question 1 and 2
Missing : Question 2 - BMI
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Correct Response to Question 1 and 2
Comprehension : Question 1 - age over 70
|
5 Participants
|
17 Participants
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: 1 participant did not respond to the study question and 1 participant was unable to view the Current website. Using an intention to treat approach, we included both participants in the final analysis.
Perceived value of information will be determined via patient responses to the following question, "How useful is the information in the report card in helping you choose a transplant center for you or your family?" Response choices to the questions will be based on a 5-point Likert-type scale (1 = extremely useful to 5 = not useful at all; score 1 indicates the better outcome and score 5 indicates worse outcome).
Outcome measures
| Measure |
Arm 1: SRTR Website First, Question 1 First
n=68 Participants
Show patient SRTRT website first, then question 1 first
|
Arm 2: SRTR Website First, Question 2 First
n=68 Participants
Show patient SRTRT website first, then question 2 first
|
Arm 3: TCST First, Question 1 First
Show patient TCST website first, then question 1 first.
|
Arm 4: TCST First, Question 2 First
Show patient TCST website first, then question 2 first.
|
|---|---|---|---|---|
|
Perceived Value of Information
|
2.16 units on a scale
Standard Deviation 1.03
|
1.97 units on a scale
Standard Deviation 1.02
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: This was a cross-over study design.
We measured satisfaction with decision-making and decisional conflict using the Ottawa Decisional Conflict Scale (DCS). Participants were asked to answer four items to assess satisfaction with decision making. These four items are: a) summed; b) divided by 4; and c) multiplied by 25. Scores ranges from 0 \[great satisfaction\] to 100 \[lower satisfaction\].
Outcome measures
| Measure |
Arm 1: SRTR Website First, Question 1 First
n=68 Participants
Show patient SRTRT website first, then question 1 first
|
Arm 2: SRTR Website First, Question 2 First
n=68 Participants
Show patient SRTRT website first, then question 2 first
|
Arm 3: TCST First, Question 1 First
Show patient TCST website first, then question 1 first.
|
Arm 4: TCST First, Question 2 First
Show patient TCST website first, then question 2 first.
|
|---|---|---|---|---|
|
Measurement of Satisfaction With Decision Making
|
15.5 units on a scale
Standard Deviation 19.6
|
13.4 units on a scale
Standard Deviation 19.7
|
—
|
—
|
Adverse Events
Current Website
New Patient Centered Website
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ajay Israni, MD, MS - Division Chief - Transplant & General Nephrology
University of Texas - Medical Branch
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place