Health Systems Intervention for Kidney Disease

Enrolling by invitation at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Non-participating centers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to simplify the process for patients to begin obtaining a kidney transplant. It tests a special approach, the RaDIANT Health Systems Intervention, which enhances communication between transplant centers, patients, and dialysis centers. The goal is to remove barriers so more patients can receive the necessary evaluations to start their transplant journey. Patients at dialysis centers in Georgia, North Carolina, South Carolina, or Indiana who have been referred to a participating transplant center may find this trial suitable. As an unphased trial, it provides a unique opportunity to improve the transplant process and potentially benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this health systems intervention is safe for improving access to transplant evaluation?

Research has shown that the RaDIANT Health Systems Intervention aims to simplify the evaluation process for kidney transplants. This approach enhances communication and support among patients, clinics, and transplant centers. Because this intervention involves changes in communication and management rather than a drug or medical procedure, it does not present typical safety concerns like side effects or adverse events associated with medications. Thus, the intervention is generally safe for participants. It focuses on making the process smoother and more efficient for those needing a kidney transplant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RaDIANT Health Systems Intervention for kidney disease because it introduces a comprehensive, multi-component approach to patient management within transplant centers. Unlike standard care, which often relies heavily on individual components of patient communication and tracking, this intervention combines performance feedback, personalized patient contact, and a secure software application called T-REX to streamline and enhance the referral process. By integrating these elements, the approach aims to improve communication between patients, dialysis facilities, and healthcare providers, potentially increasing the efficiency and success rates of kidney transplant referrals.

What evidence suggests that the RaDIANT Health Systems Intervention is effective for improving access to kidney transplant evaluation?

Research has shown that the RaDIANT Health Systems Intervention, which participants in this trial will experience, helps more people get evaluated for kidney transplants. Studies have found that this approach can reduce racial disparities in access to kidney transplants. For individuals with kidney failure, receiving a transplant instead of remaining on dialysis can lead to longer lives, improved quality of life, and lower costs. By enhancing communication between patients, dialysis centers, and transplant centers, the intervention aims to make the transplant process easier and fairer for everyone. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic renal failure or kidney disorders who are navigating the transplant process. It aims to improve access to transplant evaluations by addressing upstream barriers.

Inclusion Criteria

Five large transplant centers (Emory Transplant Center and Piedmont Transplant Center in Atlanta, GA; Medical University of SC; Duke University in Durham, NC; and Indiana University in Indianapolis, IN) with approximately 800 referring dialysis centers referring to these transplant centers

Exclusion Criteria

Individuals referred, initiating evaluation, and waitlisted at non-participating start centers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of multi-component intervention at transplant centers, including performance feedback, electronic referral platforms, and patient contact methods

6 months

Follow-up

Participants are monitored for changes in transplant evaluation start, waitlisting, and receipt

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• RaDIANT Health Systems Intervention

Trial Overview The study tests a health system intervention that includes multiple contact methods (text, phone calls), use of T-REX software for communication and tracking, changes in referral forms, and performance feedback reports.

How Is the Trial Designed?

Group I: Multi-Component Intervention Experimental Treatment 7 Interventions

Five participating transplant centers will multicomponent intervention in their management of patients referred to their transplant center for a kidney transplantation. The intervention will consist of: (1) required performance feedback reports on closed referrals; and a set of optional components that may be implemented variably by centers, including; (2) contacting patients via their preferred method; (3) phone calls to the dialysis facility during the patient's dialysis session; (4) phone calls to the referring or other provider; (5) use of a multi-module, secure, web-enabled software application called Transplant Referral EXchange (T-REX) or secure email to communicate patient status and no-show information; and (6) communication tracking and audit. Dialysis facilities in GA, NC, SC, and IN will receive resources to support an awareness campaign to support implementation of intervention activities within transplant centers.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Emory Healthcare

Collaborator

Trials

6

Recruited

1,900+

Piedmont Healthcare

Collaborator

Trials

23

Recruited

5,700+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11121937

The RaDIANT Health Systems Intervention for ... - NIH RePORTER For most patients with end-stage kidney failure, kidney transplantation confers longer survival, better quality of life, and lower cost, relative to dialysis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07033117

NCT07033117 | RaDIANT Health Systems Intervention Performance feedback reports will reflect each transplant center's performance related to kidney transplant evaluation initiation and referral closure. These ...

3. estar-transplant.org estar-transplant.org/about-us/radiant-study/

Reducing Disparities in Access to Kidney Transplantation ... The study seeks to evaluate the effectiveness of a multilevel intervention targeting ESRD patients and dialysis facility staff in reducing racial disparities ...

4. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-017-0807-z

Process evaluation of the RaDIANT community study: a ... Results of an outcome evaluation demonstrated the effectiveness of the Reducing Disparities in Access to kidNey Transplantation Community Study ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468024920313504

Effect of the ASCENT Intervention to Increase Knowledge ... The Allocation System Changes for Equity in Kidney Transplantation (ASCENT) trial was a cluster-randomized pragmatic, effectiveness-implementation study ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4230631/

The RaDIANT community study protocol - PubMed Central - NIH The primary outcome is change in facility-level referral for kidney transplantation from baseline to 12 months; the secondary outcome is ...

7. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/1471-2369-15-171

community-based participatory research for reducing ... The primary aim of the RaDIANT Community Study is to improve referral for kidney transplantation among AA ESRD patients in GA (primary outcome ...