search
Back to results

Disparities in National Kidney Allocation Policy (ASCENT)

Primary Purpose

Kidney Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Performance Feedback Reports
Educational Video for Staff
Educational Video for Patients
Educational Webinar
Standard Care
United Network for Organ Sharing (UNOS) Pamphlet
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Disorders focused on measuring Transplantation Surgery, Nephrology, Organ and Tissue Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Clinic
  • Emory University Hospital
  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multi-Component Intervention

Standard Care + Pamphlet

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Percentage of Patients Waitlisting at Baseline and One Year Post-intervention
The difference between proportion of new patients wait listed from baseline.
Wait Listing Disparity at Baseline and One Year Post-intervention
The proportion of African Americans versus Caucasians wait listed at baseline and up to one year post-intervention.

Secondary Outcome Measures

Knowledge About the Kidney Allocation System at Baseline and One Year Post-intervention
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.
Percentage of Staff Training About Kidney Transplant and the Allocation System at Baseline and Post-intervention
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%
Patient Education About Kidney Transplant at Baseline and Post-intervention
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%.
Intent to Refer Patients to Kidney Transplantation at Baseline and Post-intervention
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

Full Information

First Posted
August 23, 2016
Last Updated
September 29, 2022
Sponsor
Emory University
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT02879812
Brief Title
Disparities in National Kidney Allocation Policy
Acronym
ASCENT
Official Title
Allocation System Changes for Equity in kidNey Transplantation (ASCENT) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 2, 2019 (Actual)
Study Completion Date
August 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disorders
Keywords
Transplantation Surgery, Nephrology, Organ and Tissue Transplantation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-Component Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care + Pamphlet
Arm Type
Active Comparator
Arm Description
End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff.
Intervention Type
Other
Intervention Name(s)
Performance Feedback Reports
Other Intervention Name(s)
Audit and Feedback Report
Intervention Description
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
Intervention Name(s)
Educational Video for Staff
Intervention Description
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
Intervention Name(s)
Educational Video for Patients
Intervention Description
Dialysis facilities will receive a ~10 minute educational video targeted to dialysis patients to explain the transplant process and allocation policy.
Intervention Type
Other
Intervention Name(s)
Educational Webinar
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Dialysis facilities will conduct standard or usual care and education regarding transplantation.
Intervention Type
Other
Intervention Name(s)
United Network for Organ Sharing (UNOS) Pamphlet
Intervention Description
Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy .
Primary Outcome Measure Information:
Title
Percentage of Patients Waitlisting at Baseline and One Year Post-intervention
Description
The difference between proportion of new patients wait listed from baseline.
Time Frame
Baseline, Post Intervention (Up to one year)
Title
Wait Listing Disparity at Baseline and One Year Post-intervention
Description
The proportion of African Americans versus Caucasians wait listed at baseline and up to one year post-intervention.
Time Frame
Baseline, Post Intervention (Up to one year)
Secondary Outcome Measure Information:
Title
Knowledge About the Kidney Allocation System at Baseline and One Year Post-intervention
Description
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.
Time Frame
Baseline, Post Intervention (Up to one year)
Title
Percentage of Staff Training About Kidney Transplant and the Allocation System at Baseline and Post-intervention
Description
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%
Time Frame
Baseline, Post Intervention (Up to 3 months)
Title
Patient Education About Kidney Transplant at Baseline and Post-intervention
Description
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%.
Time Frame
Duration of Study (Up to 3 months)
Title
Intent to Refer Patients to Kidney Transplantation at Baseline and Post-intervention
Description
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
Time Frame
Baseline, Post Intervention (Up to 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Patzer, PhD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Disparities in National Kidney Allocation Policy

We'll reach out to this number within 24 hrs