Reducing Disparities in Access to Kidney Transplantation (RaDIANT) Regional Study

NCT02389387 | Completed

• 2 other identifiers: IRB000795965U01MD010611-05
• Study Type: observational
• Target: 440
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to facilitate coordination of transplant centers in North Carolina, South Carolina, and Georgia to share kidney transplant referral data in patients with End-Stage Renal Disease (ESRD) who are candidates for kidney transplantation.

Conditions

End-stage Renal Disease

Keywords

Dialysis Facilities; African Americans; Racial Disparity; Kidney Transplantation; Community-based Participatory Research; Coalition

Outcome Measures

Primary Outcomes (1)

• Change in Referral Disparity from baseline

  Assessed by referral disparity ratio: percentage of African American patients over percentage of white patients referred (%AA referred/%white referred) to compare across intervention and control facilities at baseline and one year after completion of the intervention. This is a facility level outcome.

  Baseline, one year after completion of the intervention

Secondary Outcomes (2)

• Change in medical evaluation start racial disparity and waitlisting racial disparity

  Baseline, 6 months after referral, one year after the start of medical evaluation

• Change in number of referrals between Control and Experimental patients from baseline

  Baseline, 6 months after referral, one year after referral

Study Arms (2)

Control

Two hundred twenty (220) dialysis facilities will follow standard of care practices in their management of ESRD patients. They will not receive interventions, but they will have access to standard educational materials and quality improvement through End Stage Renal Disease Network 6.

Intensive Intervention

Two hundred twenty (220) dialysis facilities will follow standard of care practices and the intensive intervention in their management of ESRD patients. The intensive intervention will consist of 1) A multi-module, secure, web-enabled software application called Transplant Referral EXchange (T-REX) to enhance coordination between dialysis and transplant staff and track ESRD patients through the seven primary steps to transplant , 2) educational webinars/seminars for staff, 3) facility-specific performance feedback reports, 4) assistance with and review of center-specific action plans to increase transplant referral, 5) scheduled bi-annual phone calls with an SETC member to monitor progress, 6) patient education on transplant via creation of an Education Station in facility lobby, and 7) development of a Peer Mentor program.

Other: Intensive Intervention

Interventions

Intensive Intervention OTHER

I.A multi-module, secure, web-enabled software application called Transplant Referral EXchange (T-REX):1) real-time communication between staff across healthcare settings, documenting the use of transplant education materials, 2) sending/receiving electronic referrals for transplant specific to a transplant center's requirements and 3) tracking patients' status in the transplant process (e.g., patient interest in transplant, referral for transplant, evaluation start/completion, waitlist status, and transplant) II. Educational webinars/seminars for staff, III. Facility-specific performance feedback reports, IV. Assistance with and review of center-specific action plans to increase transplant referral, V. Scheduled bi-annual phone calls with an SETC member to monitor progress, VI. Patient education on transplant via creation of an Education Station in facility lobby, VII. Development of a Peer Mentor program.

Intensive Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Research assistants from GA transplant centers will contact \~1500 patients via phone. These are patients that were referred for kidney transplant in 2014 that did and did not start the evaluation process. Verbal consent will be obtained, and then conduct the surveys by phone to ensure that patients with any literacy or visual barriers are included in the study.

You may qualify if:

• Kidney transplant centers in the geographic area of North Carolina (NC), South Carolina (SC) and Georgia (GA)
• Low rates of referral for kidney transplantation (6-month crude referral risk mean of 0.06 and all facilities with a crude referral risk less than the mean)
• The presence of a racial disparity (African American vs. Caucasian) in referrals for kidney transplantation (racial disparity calculated based on the crude referral risk difference and the standardized referral risk difference.)
• The final pool of 440 facilities will be randomized to either the intervention or control group using a one to one ratio.

You may not qualify if:

• Close out date populated
• Transplant and hospital-based facility
• Home dialysis facility
• Patient census \<25
• \>100 miles from nearest transplant center
• Non-profit facility (except Wake Forest University Dialysis)

Sponsors & Collaborators

• Emory University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Related Publications (1)

• Patzer RE, Buford J, Urbanski M, McPherson L, Paul S, Di M, Harding JL, Katz-Greenberg G, Rossi A, Anand PM, Reeves-Daniel A, Jones H, Mulloy L, Pastan SO; Southeastern Kidney Transplant Coalition. Reducing Disparities in Access to Kidney Transplantation Regional Study: A Randomized Trial in the Southeastern United States. Clin J Am Soc Nephrol. 2024 Dec 13;20(2):256-66. doi: 10.2215/CJN.0000000586. Online ahead of print.

  PMID: 39671258 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; 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 Officials

• Rachel Patzer, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share