Disparities in National Kidney Allocation Policy (ASCENT)

Allocation System for Changes in Equity in kidNey Transplantation (ASCENT) Study

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 56332
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: Audit and Feedback Report; 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.; 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.; 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 .; 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.
Active Comparator: 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.	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 .; Other: Standard Care; Dialysis facilities will conduct standard or usual care and education regarding transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge About the Kidney Allocation System	Knowledge about the kidney allocation system was assessed using a survey among dialysis facility medical directors or nurse managers. The survey measured provider knowledge of Kidney Allocation System (KAS) and transplantation using a cumulative knowledge score ranging from 0 to 5, where 0 = least knowledge and 5 = highest level of knowledge (higher scores are preferable, indicating greater knowledge).	Baseline, Immediately Post-intervention (3 months after the start of the intervention)
Percentage of Facilities With Increases or No Change/Decreases in Staff Training	Staff training about kidney transplant and the allocation system was assessed among dialysis facility medical directors or nurse managers by asking "what proportion of staff have you trained regarding the new kidney allocations system?" The staff training score was based on facility-level average percent and used a scale of 0 = 0% of staff trained, 1 = 1-20% of staff trained, 2 = 21-40% of staff trained, 3 = 41-60% of staff trained, 4 = 61-80% of staff trained, and 5 = 81-100% of staff trained. Facilities were grouped as either having an increase in the percentage of staff who were trained about KAS, or had no change or a decrease in the percentage of staff trained between the baseline and post-intervention follow-up at 3 months.	Baseline, Immediately Post-intervention (3 months after the start of the intervention)
Percentage of Facilities With Increases or No Change/Decreases in Patient Education	Patient education about kidney transplant and the allocation system was assessed among dialysis facility medical directors or nurse managers by asking "what proportion of patients in this specific facility have you or your staff educated about kidney transplantation?" The patient education score was based on facility-level average percent and recorded as ordinal responses scored on a scale of 0 = 0% of patients educated, 1 = 1-20% of patients educated, 2 = 21-40% of patients educated, 3 = 41-60% of patients educated, 4 = 61-80% of patients educated, and 5 = 81-100% of patients educated. Facilities were grouped as either having an increase in the percentage of patients educated about KAS, or had no change or a decrease in the percentage of patients educated between the baseline and post-intervention follow-up at 3 months.	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	Change in referral practices were measured by asking dialysis facility medical directors or nurse managers about the estimated number of patients where were referred for kidney transplantation in that facility. The medical director or nurse manager was asked "since the beginning of the ASCENT quality improvement project (about 3 months ago), have you been referring more or fewer patients?" Possible responses were: more, same, fewer, or unsure. Facilities were grouped as either having an increase in the number of patients referred for transplant, or had no change or a decrease in the proportion of patients referred for transplant.	Immediately Post-intervention (3 months after the start of the intervention)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Rachel Patzer, PhD, MPH, Emory University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimated): August 26, 2016

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Nephrology; End stage renal disease (ESRD); Transplantation Surgery; Organ and Tissue Transplantation
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Kidney Failure, Chronic; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB00081580; 1R01MD010290-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No