Disparities in National Kidney Allocation Policy (ASCENT)

September 18, 2025 updated by: Rachel Patzer, Emory University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56332

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Incident Patients Waitlisted
Time Frame: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)
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
Time Frame: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)
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
Time Frame: Baseline (the twelve month period prior to the intervention)
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
Time Frame: Post-intervention (the twelve month period after the intervention)
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
Time Frame: Baseline (the twelve month period prior to the intervention)
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
Time Frame: Post-intervention (the twelve month period after the intervention)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge About the Kidney Allocation System
Time Frame: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
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
Time Frame: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
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
Time Frame: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
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
Time Frame: Immediately Post-intervention (3 months after the start of the intervention)
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Patzer, PhD, MPH, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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