Overview

This trial is active, not recruiting.

Condition end-stage renal disease
Treatment behavioral interventions for dialysis facilities
Sponsor Emory University
Start date March 2015
End date June 2020
Trial size 140 participants
Trial identifier NCT02389387, IRB00079596

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
Seventy (70) 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.
(Experimental)
Seventy (70) 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) educational webinars/seminars for staff, 2) facility-specific performance feedback reports, 3) assistance with and review of center-specific action plans to increase transplant referral, and 4) scheduled bi-annual phone calls with an SETC member to monitor progress.
behavioral interventions for dialysis facilities
Educational seminars and monthly educational webinars Peer-to-peer mentoring program Bulletin boards about transplantation Facility-specific feedback reports detailing transplant referral data for their center compared to state average Formulate a facility-specific improvement plan to increase transplant referrals. Requirement to form a Patient and Family Advisory Group to increase outreach about transplant education within the facility. Monthly monitoring and reporting of patient referrals to ESRD Network Conduct a patient and family education session about transplantation Host a movie day to show Living ACTS (About Choices in Transplantation & Sharing) video

Primary Outcomes

Measure
Change in number of referrals for kidney transplantation
time frame: Baseline, one year after completion of the intervention

Secondary Outcomes

Measure
Change in number of evaluations for kidney transplantation
time frame: Baseline, one year after referral
Racial disparity reduction in referral and evaluation
time frame: Change from one year prior to one year post study

Eligibility Criteria

Male or female participants at least 18 years old.

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 140 facilities will be randomized to either the intervention or control group using a one to one ratio. Exclusion Criteria: 1. Facilities with less than 13 End Stage Renal Disease (ESRD) patients <70 years of age within a facility 2. Facilities with no racial disparities and high rates of referrals for kidney transplantation

Additional Information

Official title Reducing Disparities in Access to Kidney Transplantation: The RaDIANT Regional Study
Principal investigator Rachel Patzer, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Emory University.