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

End-stage Renal Disease Clinical Trial

Official title:

Reducing Disparities in Access to Kidney Transplantation: The RaDIANT Regional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389387
• Other study ID #: IRB00079596
• Secondary ID: 5U01MD010611-05
• Status: Completed
• Start date: March 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute on Minority Health and Health Disparities (NIMHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in medical evaluation start racial disparity and waitlisting racial disparity	Assessed by the racial disparity ratio (%AA/%white) by facility group (control or experimental) for medical evaluation start within 6 months of referral and placement on the waitlist within 1 year of initiating the medical evaluation. This is a facility level outcome.	Baseline, 6 months after referral, one year after the start of medical evaluation
Secondary	Change in number of referrals between Control and Experimental patients from baseline	Number of individual-patient referrals within 1 year of dialysis start, medical evaluation start within 6 months among those referred, and waitlisting within 1 year among those who start evaluation, among experimental vs. control patients.	Baseline, 6 months after referral, one year after referral