Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT07033117

Conditions

End Stage Renal Disease (ESRD)

Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Performance Feedback Reports on Referral and Evaluation Closures

Dialysis Facility Awareness Campaign

Patient Contact via Preferred Method

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

Phone Call to Provider

Study Details

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

Study ID

NCT07033117

Start date

Oct 27, 2025

Status verified date

May, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

14000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Patient Contact via Preferred Method

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

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.

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.

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.

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.

Primary outcome measure

  • Change in transplant evaluation start within 6 months of transplant referral [ Time Frame: Baseline, Post Intervention (Up to one year) ]

Central Contacts and Locations

Locations

Piedmont Transplant Institute

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Emory Transplant Center

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

IU Health Transplant - Indianapolis

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Jonathan Fridell, MD

(317) 944-4370jfridell@iu.edu

Duke Transplant Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

MUSC Mid-Carolinas Transplant Center

Recruiting

Lancaster, South Carolina, United States, 29720

Contacts

More Information

Sponsor

Indiana University

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-26.