Disparities in National Kidney Allocation Policy

Not Applicable

Completed

• Conditions: Kidney Disorders
• Interventions: Other: Performance Feedback Reports; Other: Standard Care; Other: Educational Video for Staff; Other: Educational Video for Patients; Other: Educational Webinar; Other: United Network for Organ Sharing (UNOS) Pamphlet

• Registration Number: NCT02879812
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-26
• Study Start: 2016-09
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-02
• Results First Submitted: 2020-07-30
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56332

Inclusion Criteria

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

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Exclusion Criteria

Dialysis facilities with wait listing rates above the national tertile

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-Component Intervention	Educational Webinar	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.
Multi-Component Intervention	Performance Feedback Reports	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.
Multi-Component Intervention	United Network for Organ Sharing (UNOS) Pamphlet	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.
Multi-Component Intervention	Educational Video for Staff	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.
Multi-Component Intervention	Educational Video for Patients	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.
Standard Care + Pamphlet	United Network for Organ Sharing (UNOS) Pamphlet	End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff.
Standard Care + Pamphlet	Standard Care	End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Waitlisting at Baseline and One Year Post-intervention	Baseline, Post Intervention (Up to one year)	The difference between proportion of new patients wait listed from baseline.
Wait Listing Disparity at Baseline and One Year Post-intervention	Baseline, Post Intervention (Up to one year)	The proportion of African Americans versus Caucasians wait listed at baseline and up to one year post-intervention.

Secondary Outcome Measures

Name	Time	Method
Knowledge About the Kidney Allocation System at Baseline and One Year Post-intervention	Baseline, Post Intervention (Up to one year)	Knowledge about the kidney allocation system was assessed using a survey among medical directors.; The survey was used to quantify provider knowledge of Kidney Allocation System (KAS) and transplantation using a cumulative knowledge score ranging from 0 to 5 (0=least knowledge, 5=highest level of knowledge). A higher score is a better outcome.
Percentage of Staff Training About Kidney Transplant and the Allocation System at Baseline and Post-intervention	Baseline, Post Intervention (Up to 3 months)	Staff training about kidney transplant and the allocation system was assessed using a survey among medical directors. Providers were asked what percentage of staff they think have been trained and staff training score was based on facility-level average percent. Scores range from 0 to 5 with a higher score being a better outcome.; Score scale: 0 = 0%, 1=1-20%, 2=21-40%, 3=41-60%, 4=61-80%, 5=81-100%
Patient Education About Kidney Transplant at Baseline and Post-intervention	Duration of Study (Up to 3 months)	Patient education about kidney transplant will be assessed using a survey among medical directors.; Providers were asked what percentage of patients they think have received transplant education and score was based on facility-level average percent. Scores range from 0 to 5 with a higher score being a better outcome.; Score scale: 0 = 0%, 1=1-20%, 2=21-40%, 3=41-60%, 4=61-80%, 5=81-100%.
Intent to Refer Patients to Kidney Transplantation at Baseline and Post-intervention	Baseline, Post Intervention (Up to 3 months)	Change in referral practices will be measured by surveying medical directors about the estimated proportion of patients interested,eligible, and referred for transplant in their facility. Scores were on a scale from 0 to 4 with a lower score being a better outcome.; kas.ref.overall: 1=More, 2=Same, 3=Fewer, 4=Unsure

Trial Locations

Locations (3)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States