Allocation System for Changes in Equity in kidNey Transplantation (ASCENT) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 56,332
- Locations
- 6
- Primary Endpoint
- Proportion of Incident Patients Waitlisted
Study Overview
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 Allocation System for Changes in Equity in kidNey Transplantation (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of Incident Patients Waitlisted
Time Frame: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)
The adjusted mean proportions of incident (new) patients waitlisted for kidney transplantation at study dialysis facilities, at the baseline and post-intervention time periods, were calculated. Incident patients are those who initiated dialysis treatment at study facilities during one of the study time periods. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Black and White Incident Patients Waitlisted
Time Frame: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)
The adjusted mean proportions of Black versus White incident patients waitlisted for kidney transplantation at study dialysis facilities, at the baseline and post-intervention follow-up assessments, were calculated. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Prevalent Patients Waitlisted During the Baseline Period
Time Frame: Baseline (the twelve month period prior to the intervention)
The adjusted mean proportions of prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the baseline time period were calculated. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Prevalent Patients Waitlisted During the Post-Intervention Time Period
Time Frame: Post-intervention (the twelve month period after the intervention)
The adjusted mean proportions of prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the post-intervention period were calculated. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Black and White Prevalent Patients Waitlisted During the Baseline Period
Time Frame: Baseline (the twelve month period prior to the intervention)
Waitlisting disparity is assessed as the adjusted mean proportion of Black versus White prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the baseline time period. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Black and White Prevalent Patients Waitlisted During the Post-Intervention Time Period
Time Frame: Post-intervention (the twelve month period after the intervention)
Waitlisting disparity is assessed as the adjusted mean proportion of Black versus White prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the post-intervention period. Mean proportions were adjusted for time and facility-level random effects.
Secondary Outcomes
- Knowledge About the Kidney Allocation System(Baseline, Immediately Post-intervention (3 months after the start of the intervention))
- Percentage of Facilities With Increases or No Change/Decreases in Staff Training(Baseline, Immediately Post-intervention (3 months after the start of the intervention))
- Percentage of Facilities With Increases or No Change/Decreases in Patient Education(Baseline, Immediately Post-intervention (3 months after the start of the intervention))
- Percentage of Facilities With Increases or No Change/Decreases in Intent to Refer Patients for Kidney Transplantation(Immediately Post-intervention (3 months after the start of the intervention))
Investigators
Rachel Patzer
Adjunct Professor
Emory University