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"

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

268 participants

Primary outcome timeframe

30 minutes

Results posted on

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

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

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

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 minutes

Population: 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

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 minutes

Population: 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

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 minutes

Population: 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

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

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

New Patient Centered Website

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

Ajay Israni, MD, MS - Division Chief - Transplant & General Nephrology

University of Texas - Medical Branch

Phone: 409 772 2473

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place