Clinical trial NCT02879812: Disparities in National Kidney Allocation Policy
Official title: Allocation System Changes for Equity in kidNey Transplantation (ASCENT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Disorders
Keywords: Transplantation Surgery
Nephrology
Organ and Tissue Transplantation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2016-08-26
Enrollment: 56332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the current study is to test a systems-level approach to disseminate a multicomponent, multilevel intervention consisting of educational materials about transplantation and the new kidney allocation system targeting dialysis facility Medical Directors, staff, and patients. Roughly 750 dialysis facilities in up to 18 end stage renal disease Network regions across the United States will be randomized to receive intervention materials. The overall goal of the study is to extend the influence of the national allocation policy in reducing disparities in early steps in kidney transplant access.

Detailed description: The purpose of the ASCENT study is to test a systems-level approach to disseminate a multi-component intervention consisting of in the era of the new national kidney allocation policy and educational materials targeting dialysis facility Medical Directors, staff, and patients. The investigators will randomize \~750 dialysis facilities in up to 18 End Stage Renal Disease Network regions across the United States, where approximately half of facilities will receive the intervention materials and half will receive an informational brochure. This pragmatic, clinical effectiveness-implementation study will test the effectiveness of the multicomponent, multilevel interventions consisting of a tailored, facility-specific transplant and disparity performance report, educational videos for staff and dialysis patients, and an educational webinar for dialysis facility Medical Directors and staff.

Eligibility criteria: Inclusion Criteria:

Dialysis facilities with at least 25 patients composed of at least 10% African American and 10% Caucasian

Exclusion Criteria:

Dialysis facilities with wait listing rates above the national tertile

Primary outcomes:
measure: Percentage of Patients Waitlisting at Baseline and One Year Post-intervention
timeFrame: Baseline, Post Intervention (Up to one year)
measure: Wait Listing Disparity at Baseline and One Year Post-intervention
timeFrame: Baseline, Post Intervention (Up to one year)
Secondary outcomes:
measure: Knowledge About the Kidney Allocation System at Baseline and One Year Post-intervention
timeFrame: Baseline, Post Intervention (Up to one year)
measure: Percentage of Staff Training About Kidney Transplant and the Allocation System at Baseline and Post-intervention
timeFrame: Baseline, Post Intervention (Up to 3 months)
measure: Patient Education About Kidney Transplant at Baseline and Post-intervention
timeFrame: Duration of Study (Up to 3 months)
measure: Intent to Refer Patients to Kidney Transplantation at Baseline and Post-intervention
timeFrame: Baseline, Post Intervention (Up to 3 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Rachel Patzer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: