Disparities in National Kidney Allocation Policy

NCT ID: NCT02879812

Last Updated: 2025-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-08-02

Brief Summary

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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

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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.

Conditions

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Kidney Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Multi-Component Intervention

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.

Group Type EXPERIMENTAL

Performance Feedback Reports

Intervention Type OTHER

Medical directors will be provided performance feedback reports that are a summary of clinical performance of transplant and racial disparity performance over a period of time aimed at providing information to allow them to assess and adjust their transplant performance. The report will emphasize tailored facility-specific information on the mean time on dialysis for patients in that facility and transplant access performance measures, such as wait listing and transplantation, including the magnitude of racial disparity, detailing when a facility is performing below the national or regional average.

Educational Video for Staff

Intervention Type OTHER

Dialysis facility staff will watch a \~10 minute educational video that describes the role of dialysis staff in improving transplant access, the new kidney allocation policy, and how the new policy impacts minority patients and those on dialysis for a substantial period of time.

Educational Video for Patients

Intervention Type OTHER

Dialysis facilities will receive a \~10 minute educational video targeted to dialysis patients to explain the transplant process and allocation policy.

Educational Webinar

Intervention Type OTHER

Education for medical directors and facility staff about the kidney allocation policy will be discussed in a webinar and information will be hosted on a website for participants to access. The seminar will be roughly 45 minutes, and continuing medical education (CME) credits will be offered.

United Network for Organ Sharing (UNOS) Pamphlet

Intervention Type OTHER

Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy .

Standard Care + Pamphlet

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

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

Dialysis facilities will conduct standard or usual care and education regarding transplantation.

United Network for Organ Sharing (UNOS) Pamphlet

Intervention Type OTHER

Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy .

Interventions

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Performance Feedback Reports

Medical directors will be provided performance feedback reports that are a summary of clinical performance of transplant and racial disparity performance over a period of time aimed at providing information to allow them to assess and adjust their transplant performance. The report will emphasize tailored facility-specific information on the mean time on dialysis for patients in that facility and transplant access performance measures, such as wait listing and transplantation, including the magnitude of racial disparity, detailing when a facility is performing below the national or regional average.

Intervention Type OTHER

Educational Video for Staff

Dialysis facility staff will watch a \~10 minute educational video that describes the role of dialysis staff in improving transplant access, the new kidney allocation policy, and how the new policy impacts minority patients and those on dialysis for a substantial period of time.

Intervention Type OTHER

Educational Video for Patients

Dialysis facilities will receive a \~10 minute educational video targeted to dialysis patients to explain the transplant process and allocation policy.

Intervention Type OTHER

Educational Webinar

Education for medical directors and facility staff about the kidney allocation policy will be discussed in a webinar and information will be hosted on a website for participants to access. The seminar will be roughly 45 minutes, and continuing medical education (CME) credits will be offered.

Intervention Type OTHER

Standard Care

Dialysis facilities will conduct standard or usual care and education regarding transplantation.

Intervention Type OTHER

United Network for Organ Sharing (UNOS) Pamphlet

Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy .

Intervention Type OTHER

Other Intervention Names

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Audit and Feedback Report

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Rachel Patzer

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Patzer, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory Clinic

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Urbanski M, Lee YH, Escoffery C, Buford J, Plantinga L, Pastan SO, Hamoda R, Blythe E, Patzer RE. Implementation of the ASCENT Trial to Improve Transplant Waitlisting Access. Kidney Int Rep. 2023 Nov 2;9(2):225-238. doi: 10.1016/j.ekir.2023.10.028. eCollection 2024 Feb.

Reference Type BACKGROUND
PMID: 38344743 (View on PubMed)

Patzer RE, Smith K, Basu M, Gander J, Mohan S, Escoffery C, Plantinga L, Melanson T, Kalloo S, Green G, Berlin A, Renville G, Browne T, Turgeon N, Caponi S, Zhang R, Pastan S. The ASCENT (Allocation System Changes for Equity in Kidney Transplantation) Study: a Randomized Effectiveness-Implementation Study to Improve Kidney Transplant Waitlisting and Reduce Racial Disparity. Kidney Int Rep. 2017 May;2(3):433-441. doi: 10.1016/j.ekir.2017.02.002. Epub 2017 Feb 9.

Reference Type BACKGROUND
PMID: 28845470 (View on PubMed)

Patzer RE, Zhang R, Buford J, McPherson L, Lee YH, Urbanski M, Li D, Wilk A, Paul S, Plantinga L, Escoffery C, Pastan SO. The ASCENT Intervention to Improve Access and Reduce Racial Inequalities in Kidney Waitlisting: A Randomized, Effectiveness-Implementation Trial. Clin J Am Soc Nephrol. 2023 Mar 1;18(3):374-382. doi: 10.2215/CJN.0000000000000071. Epub 2023 Feb 8.

Reference Type RESULT
PMID: 36764664 (View on PubMed)

Magua W, Basu M, Pastan SO, Kim JJ, Smith K, Gander J, Mohan S, Escoffery C, Plantinga LC, Melanson T, Garber MD, Patzer RE. Effect of the ASCENT Intervention to Increase Knowledge of Kidney Allocation Policy Changes Among Dialysis Providers. Kidney Int Rep. 2020 Jul 2;5(9):1422-1431. doi: 10.1016/j.ekir.2020.06.027. eCollection 2020 Sep.

Reference Type RESULT
PMID: 32954067 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01MD010290-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00081580

Identifier Type: -

Identifier Source: org_study_id

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