Clinical trial NCT02389387: Reducing Disparities in Access to Kidney Transplantation (RaDIANT) Regional Study
Official title: Reducing Disparities in Access to Kidney Transplantation: The RaDIANT Regional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-stage Renal Disease
Keywords: Dialysis Facilities
African Americans
Racial Disparity
Kidney Transplantation
Community-based Participatory Research
Coalition
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2015-03-17
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Change in Referral Disparity from baseline
timeFrame: Baseline, one year after completion of the intervention
Secondary outcomes:
measure: Change in medical evaluation start racial disparity and waitlisting racial disparity
timeFrame: Baseline, 6 months after referral, one year after the start of medical evaluation
measure: Change in number of referrals between Control and Experimental patients from baseline
timeFrame: Baseline, 6 months after referral, one year after referral
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Rachel Patzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: