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

NCT ID: NCT02389387

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2021-06-30

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.

Detailed Description

Disparities exist in access to kidney transplantation where poor and minority patients are less likely to access each step of the kidney transplant process. Current national surveillance data does not capture information on transplant referral, and it is unclear to what extent dialysis facility-level factors may influence disparities in access to transplantation. Due to significant variability in the standardized transplant ratios observed at each facility, the investigators hypothesize that there may be facility-related reasons that impact disparities in access to the first step of the kidney transplant process -- referral to the transplant center to undergo an evaluation for the suitability for transplant.

Conditions

End-stage Renal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

Intensive Intervention

Intervention Type: 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.

Interventions

Intensive Intervention

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Kidney transplant centers in the geographic area of North Carolina (NC), South Carolina (SC) and Georgia (GA)

2. 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)

3. 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.

Exclusion Criteria

1. Close out date populated

2. Transplant and hospital-based facility

3. Home dialysis facility

4. Patient census <25

5. >100 miles from nearest transplant center

6. Non-profit facility (except Wake Forest University Dialysis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Rachel Patzer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Patzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

References

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.

Reference Type: DERIVED

PMID: 39671258 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

5U01MD010611-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00079596

Identifier Type: -

Identifier Source: org_study_id