Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03610555 |
| Other study ID # |
HSR#16-4130 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2016 |
| Est. completion date |
January 2026 |
Study information
| Verified date |
January 2024 |
| Source |
Hennepin Healthcare Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
