RaDIANT Health Systems Intervention

NCT07033117 | Enrolling By Invitation DMC

• 2 other identifiers: 18998 - Aim 2R01DK136283
• Study Type: interventional
• Target: 14,000
• Locations: 1 country
• Sites: 5

Brief Summary

The overarching goal of the proposed study is to determine whether the addition of structural interventions at the health system level targeting upstream barriers in the transplant process will improve access to transplant evaluation start.

Conditions

End Stage Renal Disease (ESRD); Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in transplant evaluation start within 6 months of transplant referral

  The difference in the proportion of patients starting transplant evaluation within 6 months of being referred from baseline to up to one-year post-intervention

  Baseline, Post Intervention (Up to one year)

Secondary Outcomes (2)

• Change in transplant waitlisting

  Baseline, Post Intervention (Up to one year)

• Change in transplant receipt among those who were waitlisted

  Baseline, Post Intervention (Up to one year)

Study Arms (1)

Multi-Component Intervention

EXPERIMENTAL

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.

Other: Performance Feedback Reports on Referral and Evaluation Closures; Other: Dialysis Facility Awareness Campaign; Other: Patient Contact via Preferred Method; Other: Phone Call to Dialysis Facility During the Patient's Dialysis Session; Other: Phone Call to Provider; Other: Transplant Referral Communication Platforms or Email to Communicate Patient Status and No-Show; Other: Audit and Tracking of Patient Contact Attempts Prior to Referral Closure

Interventions

Performance Feedback Reports on Referral and Evaluation Closures OTHER

Performance feedback reports will reflect each transplant center's performance related to kidney transplant evaluation initiation and referral closure. These reports aim to help centers understand common reasons why patients do not initiate the evaluation process or failed to proceed beyond the evaluation process, and to identify patterns in referral and evaluation closure practices. Reports will be individualized and distributed quarterly to the transplant center champion by the intervention lead.

Multi-Component Intervention

Dialysis Facility Awareness Campaign OTHER

As part of the intervention, dialysis centers will participate in an Awareness Campaign designed to educate staff about transplant center quality improvement efforts and how they may be contacted as part of the project. This campaign may include brief webinars or informative documents distributed via platforms such as IPRO Learn.

Multi-Component Intervention

Patient Contact via Preferred Method OTHER

Transplant centers will contact patients using their preferred method of communication.

Multi-Component Intervention

Phone Call to Dialysis Facility During the Patient's Dialysis Session OTHER

Facilities will enhance their patient communication procedures by making a phone call to the dialysis facility during the patient's dialysis session if the patient has not responded to initial outreach attempts. This additional step increases the likelihood of reaching the patient during a time when they are accessible and can engage in scheduling or follow-up.

Multi-Component Intervention

Phone Call to Provider OTHER

Transplant centers will enhance their outreach procedures by making a phone call to the referring provider (e.g., nephrologist, medical assistant) or another provider involved in the patient's care (e.g., primary care provider) in the event of self-referral if the patient has not responded to initial outreach attempts or "no-shows" an initial evaluation appointment. This additional step ensures that the referring provider is informed of the patient's progress and can assist in re-engagement or decision-making prior to referral closure.

Multi-Component Intervention

Transplant Referral Communication Platforms or Email to Communicate Patient Status and No-Show OTHER

Transplant center staff will utilize transplant referral communication platforms and/or email to communicate updates to dialysis staff regarding patient status (e.g., unable to contact the patient or no-show) before referral closure.

Multi-Component Intervention

Audit and Tracking of Patient Contact Attempts Prior to Referral Closure OTHER

Transplant center staff will continue internally tracking the frequency that a patient is contacted before closure and the date of closure, in alignment with center standard practice. This intervention introduces an audit process to be conducted before closure to ensure that all contact attempts (including one or more attempts to contact the patient directly, one or more phone calls to the alternate preferred contact, or one or more attempted contacts to the dialysis unit to connect with the patient), in alignment with center communication procedures, are appropriately executed.

Multi-Component Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \~800 referring dialysis center referring to these transplant centers

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Indiana University Health: collaborator
• Emory Healthcare: collaborator
• Piedmont Healthcare: collaborator
• Medical University of South Carolina: collaborator
• Duke University: collaborator

Study Sites (5)

Piedmont Transplant Institute

Atlanta, Georgia, 30309, United States

Location

Emory Transplant Center

Atlanta, Georgia, 30322, United States

Location

IU Health Transplant - Indianapolis

Indianapolis, Indiana, 46202, United States

Location

Duke Transplant Center

Durham, North Carolina, 27710, United States

Location

MUSC Mid-Carolinas Transplant Center

Lancaster, South Carolina, 29720, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)