Disparities in National Kidney Allocation Policy (ASCENT)

Emory University

Status: Completed

Conditions: Kidney Disorders

Treatments: Other: Standard Care; Other: Performance Feedback Reports; Other: Educational Webinar; Other: United Network for Organ Sharing (UNOS) Pamphlet; Other: Educational Video for Patients; Other: Educational Video for Staff

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02879812

IRB00081580

1R01MD010290-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56,332 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56,332 participants in 2 patient groups

Multi-Component Intervention

Experimental group

Description:

End Stage Renal Disease (ESRD) facilities will receive feedback reports containing facility specific data, an educational webinar for dialysis facility medical directors and staff, and an educational video for patients and staff.

Treatment:

Other: Educational Video for Staff

Other: Educational Video for Patients

Other: United Network for Organ Sharing (UNOS) Pamphlet

Other: Educational Webinar

Other: Performance Feedback Reports

Standard Care + Pamphlet

Active Comparator group

Description:

End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff.

Treatment:

Other: United Network for Organ Sharing (UNOS) Pamphlet

Other: Standard Care