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

NCT03610555 | Completed Results

• 1 other identifier: HSR#16-4130
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplants

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Correct Response to Question 1 and 2

  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 Outcomes (2)

• Perceived Value of Information

  30 minutes

• Measurement of Satisfaction With Decision Making

  30 minutes

Study Arms (4)

Arm 1

OTHER

Sequence 1: SRTR then TCST (Question 1 then Question 2)

Other: Intervention 1 - SRTR (age question 1st)

Arm 2

OTHER

Sequence 2: SRTR then TCST (Question 2 then Question 1)

Other: Intervention 2 - SRTR (BMI question 1st)

Arm 3

OTHER

Sequence 3: TCST then SRTR (Question 1 then Question 2)

Other: Intervention 3 - TCST (age question 1st)

Arm 4

OTHER

Sequence 4: TCST then SRTR (Question 2 then Question 1)

Other: Intervention 4 - TCST (BMI question 1st)

Interventions

Intervention 1 - SRTR (age question 1st) OTHER

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 1

Intervention 2 - SRTR (BMI question 1st) OTHER

Participants first viewed the SRTR website to answer Question 2. Subsequently, participants crossed over to view the TCST website to answer Question 1.

Arm 2

Intervention 3 - TCST (age question 1st) OTHER

Participants first viewed the TCST website to answer Question 1. Subsequently, participants crossed over to view the SRTR website to answer Question 2.

Arm 3

Intervention 4 - TCST (BMI question 1st) OTHER

Participants first viewed the TCST website to answer Question 2. Subsequently, participants crossed over to view the SRTR website to answer Question 1.

Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ajay Israni, MD: lead

Study Sites (1)

HCMC

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (7)

• Israni AK, Schladt D, Bruin MJ, Chu S, Snyder JJ, Hertz M, Valapour M, Kasiske B, McKinney WT, Schaffhausen CR. Deconstructing Silos of Knowledge Around Lung Transplantation to Support Patients: A Patient-specific Search of Scientific Registry of Transplant Recipients Data. Transplantation. 2022 Aug 1;106(8):1517-1519. doi: 10.1097/TP.0000000000004051. Epub 2022 Feb 11. No abstract available.

  PMID: 35152256 BACKGROUND

• Chu S, Bruin MJ, McKinney WT, Israni AK, Schaffhausen CR. Design of a patient-centered decision support tool when selecting an organ transplant center. PLoS One. 2021 May 17;16(5):e0251102. doi: 10.1371/journal.pone.0251102. eCollection 2021.

  PMID: 33999964 BACKGROUND

• McKinney WT, Schaffhausen CR, Schladt D, Bruin MJ, Chu S, Snyder JJ, Martin C, Alexy T, Kasiske B, Israni AK. Designing a patient-specific search of transplant program performance and outcomes: Feedback from heart transplant candidates and recipients. Clin Transplant. 2021 Feb;35(2):e14183. doi: 10.1111/ctr.14183. Epub 2020 Dec 19.

  PMID: 33617066 BACKGROUND

• McKinney WT, Schaffhausen CR, Bruin MJ, Chu S, Schladt D, Matas A, Snyder J, Kasiske B, Israni AK. Development of a Patient-specific Search of Transplant Program Outcomes and Characteristics: Feedback From Kidney Transplant Patients. Transplant Direct. 2020 Jul 17;6(8):e585. doi: 10.1097/TXD.0000000000001036. eCollection 2020 Aug.

  PMID: 32766433 BACKGROUND

• Schaffhausen CR, Bruin MJ, McKinney WT, Snyder JJ, Matas AJ, Kasiske BL, Israni AK. How patients choose kidney transplant centers: A qualitative study of patient experiences. Clin Transplant. 2019 May;33(5):e13523. doi: 10.1111/ctr.13523. Epub 2019 Apr 21.

  PMID: 30861199 BACKGROUND

• Schaffhausen CR, Bruin MJ, Chu S, Wey A, McKinney WT, Snyder JJ, Lake JR, Matas AJ, Kasiske BL, Israni AK. Comparing Pretransplant and Posttransplant Outcomes When Choosing a Transplant Center: Focus Groups and a Randomized Survey. Transplantation. 2020 Jan;104(1):201-210. doi: 10.1097/TP.0000000000002809.

  PMID: 31283676 BACKGROUND

• McKinney WT, Israni K, Schaffhausen CR, Schladt DP, Lyden GR, Matas A, Wolf J, Japuntich S, Israni AK. Randomized Controlled Trial to Evaluate a New Tool to Support Patient Decision-making on Transplant Centers. Clin Transplant. 2024 Dec;38(12):e70043. doi: 10.1111/ctr.70043.

  PMID: 39620865 RESULT

Related Links

• This website is the finalized version of the intervention study site.

Results Point of Contact

• Title: Ajay Israni, MD, MS - Division Chief - Transplant & General Nephrology
• Organization: University of Texas - Medical Branch

akisrani@utmb.edu

409 772 2473

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ajay Israni, M.D., M.S. Nephrologist, Hennepin Healthcare President, Hennepin Healthcare Research Institute, Professor of Medicine Adjunct Faculty School of Public Health, University of Minnesota

Model Details: Participants were stratified by transplant center site and block randomized to one of the four groups using permuted block randomization with blocks of size four. * Arm 1: SRTR website first, Question 1 first * Arm 2: SRTR website first, Question 2 first * Arm 3: TCST first, Question 1 first * Arm 4: TCST first, Question 2 first

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: August 1, 2018
• Study Start: November 1, 2016
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-12

Locations

US (1)