- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02389387
Reducing Disparities in Access to Kidney Transplantation (RaDIANT) Regional Study
April 5, 2023 updated by: Rachel Patzer, Emory University
Reducing Disparities in Access to Kidney Transplantation: The RaDIANT Regional Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
440
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Referral Disparity from baseline
Time Frame: Baseline, one year after completion of the intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in medical evaluation start racial disparity and waitlisting racial disparity
Time Frame: Baseline, 6 months after referral, one year after the start of medical evaluation
|
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
|
Change in number of referrals between Control and Experimental patients from baseline
Time Frame: Baseline, 6 months after referral, one year after referral
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rachel Patzer, PhD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
March 10, 2015
First Submitted That Met QC Criteria
March 16, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 5, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00079596
- 5U01MD010611-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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