RaDIANT Health Systems Intervention

NCT ID: NCT07033117

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 14000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-27
• Study Completion Date: 2026-07-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Performance Feedback Reports on Referral and Evaluation Closures

Intervention Type: 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.

Dialysis Facility Awareness Campaign

Intervention Type: 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.

Patient Contact via Preferred Method

Intervention Type: OTHER

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

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

Intervention Type: 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.

Phone Call to Provider

Intervention Type: 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.

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

Intervention Type: 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.

Audit and Tracking of Patient Contact Attempts Prior to Referral Closure

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: OTHER

Patient Contact via Preferred Method

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Indiana University Health

OTHER

Sponsor Role: collaborator

Emory Healthcare

OTHER

Sponsor Role: collaborator

Piedmont Healthcare

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Rachel Patzer, PhD, MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Piedmont Transplant Institute

Atlanta, Georgia, United States

Emory Transplant Center

Atlanta, Georgia, United States

IU Health Transplant - Indianapolis

Indianapolis, Indiana, United States

Duke Transplant Center

Durham, North Carolina, United States

MUSC Mid-Carolinas Transplant Center

Lancaster, South Carolina, United States

Countries

United States

Other Identifiers

R01DK136283

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18998 - Aim 2

Identifier Type: -

Identifier Source: org_study_id