RaDIANT Health Systems Intervention

The RaDIANT Health Systems Intervention for Improving Access to Kidney Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease (ESRD); Kidney Disease
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 14000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory Transplant Center
      • Contact: Stephen Pastan, MD; Phone Number: (855) 366-7989; Email: stephen.pastan@emoryhealthcare.org
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Transplant Institute
      • Contact: Ana Rossi, MD; Phone Number: (404) 605-4600; Email: ana.rossi@piedmont.org
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health Transplant - Indianapolis
      • Contact: Jonathan Fridell, MD; Phone Number: (317) 944-4370; Email: jfridell@iu.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Transplant Center
      • Contact: Goni Katz-Greenberg, MD; Phone Number: (855) 855-6484; Email: goni.katzgreenberg@duke.edu
  • South Carolina
    • Lancaster, South Carolina, United States, 29720
      • Recruiting
      • MUSC Mid-Carolinas Transplant Center
      • Contact: Prince Mohan, MD; Phone Number: (843) 792-5097; Email: mohanp@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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) ~800 referring dialysis center referring to these transplant centers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multi-Component Intervention; 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; 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.; Other: Dialysis Facility Awareness Campaign; 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.; Other: Patient Contact via Preferred Method; Transplant centers will contact patients using their preferred method of communication.; Other: Phone Call to Dialysis Facility During the Patient's Dialysis Session; 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.; Other: Phone Call to Provider; 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.; Other: Transplant Referral Communication Platforms or Email to Communicate Patient Status and No-Show; 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.; Other: Audit and Tracking of Patient Contact Attempts Prior to Referral Closure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in transplant waitlisting	The difference in the proportion of patients waitlisted from baseline and up to one-year post-intervention	Baseline, Post Intervention (Up to one year)
Change in transplant receipt among those who were waitlisted	The difference in the proportion of patients who received a transplant among those who were waitlisted from baseline and up to one-year post-intervention	Baseline, Post Intervention (Up to one year)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: June 13, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 18998 - Aim 2; R01DK136283 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No