Disparities in National Kidney Allocation Policy (ASCENT)

September 29, 2022 updated by: Rachel Patzer, Emory University

Allocation System Changes for 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

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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: 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 CME will be offered.
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 .
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
Percentage of Patients Waitlisting at Baseline and One Year Post-intervention
Time Frame: Baseline, Post Intervention (Up to one year)
The difference between proportion of new patients wait listed from baseline.
Baseline, Post Intervention (Up to one year)
Wait Listing Disparity at Baseline and One Year Post-intervention
Time Frame: 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.
Baseline, Post Intervention (Up to one year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge About the Kidney Allocation System at Baseline and One Year Post-intervention
Time Frame: 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.
Baseline, Post Intervention (Up to one year)
Percentage of Staff Training About Kidney Transplant and the Allocation System at Baseline and Post-intervention
Time Frame: 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%
Baseline, Post Intervention (Up to 3 months)
Patient Education About Kidney Transplant at Baseline and Post-intervention
Time Frame: 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%.
Duration of Study (Up to 3 months)
Intent to Refer Patients to Kidney Transplantation at Baseline and Post-intervention
Time Frame: 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
Baseline, Post Intervention (Up to 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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