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Disparities in National Kidney Allocation Policy (ASCENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02879812
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Rachel Patzer, PhD, Emory University

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.

Condition or disease Intervention/treatment Phase
Kidney Disorders Other: Performance Feedback Reports Other: Educational Video for Staff Other: Educational Video for Patients Other: Educational Webinar Other: Standard Care Other: United Network for Organ Sharing (UNOS) Pamphlet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Allocation System Changes for Equity in kidNey Transplantation (ASCENT) Study
Actual Study Start Date : September 2016
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine


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 Name: 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: Standard Care
Dialysis facilities will conduct standard or usual care and education regarding transplantation.

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 .




Primary Outcome Measures :
  1. 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 patients wait listed from baseline.

  2. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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%


  3. 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%.


  4. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879812


Locations
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United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Rachel Patzer, PhD, MPH Emory University
  Study Documents (Full-Text)

Documents provided by Rachel Patzer, PhD, Emory University:
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Responsible Party: Rachel Patzer, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02879812    
Other Study ID Numbers: IRB00081580
1R01MD010290-01 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2016    Key Record Dates
Results First Posted: September 3, 2020
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rachel Patzer, PhD, Emory University:
Transplantation Surgery
Nephrology
Organ and Tissue Transplantation
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases