Creating a Patient-centered Report Card for Solid Organ Transplant Candidates

December 12, 2025 updated by: Ajay Israni, MD

Choosing a transplant center that will accept a particular candidate can be difficult and challenging for patients with end-stage organ failure. As transplant centers have varying levels of expertise, interests, and outcomes of solid organ transplant, patient health-related characteristics influence the variation in candidates centers will accept. Most transplant candidates undergo waitlist work-ups as outpatients and many undergo transplant at centers not closest to their homes. Some are listed at more than one center. Several studies suggest that patients have a choice of centers. The PI, as Deputy Director of the Scientific Registry of Transplant Recipients (SRTR), provides comparative information to the public about each solid organ transplant center in the United States. The risk adjusted outcomes, in the report cards, account for the transplant recipient's health-related characteristics, donor characteristics and transplant related factors. Unfortunately, in their current format, the report cards are not designed for transplant candidates, many of whom may have low health literacy and numeracy.

The proposed work aims to develop and evaluate a patient-centered website and printouts of the SRTR report cards that will effectively communicate comparative information to transplant candidates about their alternatives when choosing transplant centers. We will develop a novel tool to allow candidates to tailor the report cards to their clinical profiles based on their health-related characteristics and to communicate information on alternative transplant centers that perform transplants in patients like them. Aim 1 will use focus groups to determine which transplant center characteristics to present to transplant candidates and how to present these characteristics clearly in a patient centered report card. Using this information, Aim 2 will develop a patient-centered website and printouts of the SRTR report card that effectively communicate comparative information about transplant centers to transplant candidates. Lastly, Aim 3 will conduct a randomized clinical trial to evaluate the effectiveness of the patient centered SRTR report card. We will determine transplant candidates' comprehension and the value of the comparative quality reports, and the effect on clinical decision making and status on the waiting list. After the RCT, a convenience sample of online visitors to the new website will be assessed for similar outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before the intervention, the study design with use of hypothetical scenarios will be explained to the participant. The concept of randomization will be also be explained. The participants will be asked a few questions to assess their understanding of the study design, specifically the hypothetical nature of the scenarios. We will also assess whether they understand the concept of being randomized to see one website first and then the other. Only those participants that understand the study design will be invited to participate in the intervention and will be randomized. For subjects that are randomized, a survey will be administered verbally to collect demographic information and information about their kidney disease and comorbidities. The functional health literacy and numeracy assessment and health status questionnaire will be completed. Subjects will be stratified by the transplant center site and then block randomized. One group will be shown the existing SRTR website with its existing SRTR report cards and then the website with the new patient-centered AHRQ report cards for kidney transplants. The other group will be shown the two websites in opposite order. Each participant will have at most 30 minutes to view each of the websites. After viewing each website, responses to the intervention will be collected. Sessions where participants are reviewing the websites will be recorded using Zoom. Figure 2 shows the study design whereby subjects will be block randomized once to one of the four groups consisting of 18 subjects each. At the end of the study, the patients will have access to both the websites.

The study interventions can be administered in person on a laptop. During the COVID-19 pandemic, the intervention can be administered remotely via email and zoom. The link to the websites will be sent via encrypted email and the intervention will be recorded via zoom. The recordings for subjects at Hennepin Healthcare will be stored on computers at that site.

If participant does not have your own electronic device or internet, the study will send the participant a study iPad with internet that participant can use for the intervention and then to send back to the study team. We will provide detailed instructions on how to use the iPad and Zoom application. The study will also pay for a FedEx pick up from the participants' home to return the iPad to the study team after the completion of the intervention.

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • HCMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

All transplant candidates visiting the transplant centers at the project sites are eligible for the RCT

Description

Inclusion Criteria:

All adults seeking a kidney transplant are eligible for the RCT. We will focus on recruiting kidney waitlist candidates.

Exclusion criteria:

are inability to speak or understand English, visual impairment, and inability to give consent. All vulnerable populations except for those listed in the table titled vulnerable populations, will be excluded.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Sequence 1: SRTR then TCST (Question 1 then Question 2)
Other: Intervention 1 - SRTR (age question 1st)
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?)
Other: Arm 2
Sequence 2: SRTR then TCST (Question 2 then Question 1)
Other: Intervention 2 - SRTR (BMI question 1st)
Participants first viewed the SRTR website to answer Question 2. Subsequently, participants crossed over to view the TCST website to answer Question 1.
Other: Arm 3
Sequence 3: TCST then SRTR (Question 1 then Question 2)
Other: Intervention 3 - TCST (age question 1st)
Participants first viewed the TCST website to answer Question 1. Subsequently, participants crossed over to view the SRTR website to answer Question 2.
Other: Arm 4
Sequence 4: TCST then SRTR (Question 2 then Question 1)
Other: Intervention 4 - TCST (BMI question 1st)
Participants first viewed the TCST website to answer Question 2. Subsequently, participants crossed over to view the SRTR website to answer Question 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Correct Response to Question 1 and 2
Time Frame: 30 minutes
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"
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Value of Information
Time Frame: 30 minutes
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).
30 minutes
Measurement of Satisfaction With Decision Making
Time Frame: 30 minutes
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].
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajay Israni, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Estimated)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HSR#16-4130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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