Disparities in National Kidney Allocation Policy

NCT02879812 | Completed Results DMC

• 2 other identifiers: IRB000815801R01MD010290-01
• Study Type: interventional
• Target: 56,332
• Locations: 1 country
• Sites: 3

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.

Conditions

Kidney Disorders

Keywords

Transplantation Surgery; Nephrology; Organ and Tissue Transplantation; End stage renal disease (ESRD)

Outcome Measures

Primary Outcomes (6)

• Proportion of Incident Patients Waitlisted

  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.

  Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)

• Proportion of Black and White Incident Patients Waitlisted

  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.

  Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)

• Proportion of Prevalent Patients Waitlisted During the Baseline Period

  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.

  Baseline (the twelve month period prior to the intervention)

• Proportion of Prevalent Patients Waitlisted During the Post-Intervention Time Period

  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.

  Post-intervention (the twelve month period after the intervention)

• Proportion of Black and White Prevalent Patients Waitlisted During the Baseline Period

  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.

  Baseline (the twelve month period prior to the intervention)

• Proportion of Black and White Prevalent Patients Waitlisted During the Post-Intervention Time Period

  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.

  Post-intervention (the twelve month period after the intervention)

Secondary Outcomes (4)

• 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)

Study Arms (2)

Multi-Component Intervention

EXPERIMENTAL

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.

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

Standard Care + Pamphlet

ACTIVE COMPARATOR

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

Other: Standard Care; Other: United Network for Organ Sharing (UNOS) Pamphlet

Interventions

Performance Feedback Reports 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.

Also known as: Audit and Feedback Report

Multi-Component Intervention

Educational Video for Staff 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.

Multi-Component Intervention

Educational Video for Patients OTHER

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

Multi-Component Intervention

Educational Webinar 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.

Multi-Component Intervention

Standard Care OTHER

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

Standard Care + Pamphlet

United Network for Organ Sharing (UNOS) Pamphlet OTHER

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

Multi-Component Intervention; Standard Care + Pamphlet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dialysis facilities with wait listing rates above the national tertile

Sponsors & Collaborators

• Emory University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (3)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (4)

• 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.

  PMID: 38344743 BACKGROUND

• 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.

  PMID: 28845470 BACKGROUND

• 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.

  PMID: 36764664 RESULT

• 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.

  PMID: 32954067 RESULT

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Rachel Patzer
• Organization: Emory University

rpatzer@emory.edu

404-727-6047

Study Officials

• Rachel Patzer, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: September 1, 2016
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: October 7, 2025
• Results First Posted: September 3, 2020

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)