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

• ClinicalTrials.gov Identifier: NCT03610555
• Recruitment Status: Enrolling by invitation
• First Posted: August 1, 2018
• Last Update Posted: May 10, 2021
• Sponsor: Hennepin Healthcare Research Institute
• Information provided by (Responsible Party): Hennepin Healthcare Research Institute

Study Description

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.

Condition or disease	Intervention/treatment
Transplants	Other: new patient centered website

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 1000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Target Follow-Up Duration: 7 Years
• Official Title: Creating a Patient-centered Report Card for Solid Organ Transplant Candidates
• Actual Study Start Date: November 1, 2016
• Estimated Primary Completion Date: July 2021
• Estimated Study Completion Date: January 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Current website; Show patient one of the website
New patient centered website; Show patient another (different) of the website	Other: new patient centered website

Outcome Measures

Primary Outcome Measures :

1. Comprehension of the report card [ Time Frame: one hour ]
   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 center do you think is most likely to have the best posttransplant outcome?" There will be one correct answer; respondents will choose one of the four transplant center report cards shown or respond "Don't know."

Secondary Outcome Measures :

1. Perceived value of information [ Time Frame: one hour ]
   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 = not at all useful to 5 = very useful; score 1 indicates the worst outcome and score 5 indicates better outcome).
2. Measurement of satisfaction with decision making [ Time Frame: two hours ]
   We will also measure satisfaction with decision-making and decisional conflict using the Ottawa Decisional Conflict Scale (DCS). The DCS consists of 16 questions with an overall score and subscales that address uncertainty, modifiable factors contributing to uncertainty such as feeling uninformed, clarity of values, inadequate social support, and perceived effective decision making. (1 = low decisional conflict, 5 = high decisional conflict). The overall score is calculated by summing up the subscales and the total score is considered for the measure of outcome. Overall score indicates the level of decisional conflict and lower overall score indicates better outcome.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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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Contacts and Locations

Locations

United States, Minnesota

HCMC

Minneapolis, Minnesota, United States, 55415

Sponsors and Collaborators

Hennepin Healthcare Research Institute

More Information

• Responsible Party: Hennepin Healthcare Research Institute
• ClinicalTrials.gov Identifier: NCT03610555
• Other Study ID Numbers: HSR#16-4130
• First Posted: August 1, 2018
• Last Update Posted: May 10, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No