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The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study (RaDIANT)

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ClinicalTrials.gov Identifier: NCT02092727
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Rachel Patzer, PhD, Emory University

Study Description
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Brief Summary:
The Southeastern Kidney Transplant Coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among African American End Stage Renal Disease living in Georgia, North Carolina, and South Carolina. Volunteer members of this community-based coalition include patients with kidney disease, dialysis facility staff and providers, transplant centers, quality improvement organizations, and patient advocacy organizations. The burden of kidney disease is highest in the Southeast, and yet the rate of kidney transplantation is the lowest in the nation. Further, the investigators research suggests that racial disparities in access to kidney transplantation are concentrated in the Southeast, where African Americans are less likely to access each step in the transplant process. The long-term goal of the investigators Coalition is to use community- based participatory research approaches to develop, test, and disseminate sustainable, community interventions improve access to transplant for African American patients with kidney disease. The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) community study proposes to use community-based participatory research methods to develop a multilevel intervention to reduce racial disparities in access to kidney transplantation. The long-term impact of this application will be to reduce racial disparities in the kidney disease community.

Condition or disease Intervention/treatment Phase
Kidney Disease Behavioral: Behavioral Interventions for Dialysis Facilities Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Standard of care arm will receive no specific interventions, but will have access to standard educational materials and quality improvement through End Stage Renal Disease Network 6.
Experimental: Behavioral Intervention
A variety of dialysis facility-level, behavioral interventions will be examined.
 Behavioral: Behavioral Interventions for Dialysis Facilities
  1. Educational seminars and monthly educational webinars
  2. Peer-to-peer mentoring program
  3. Bulletin boards about transplantation
  4. Facility-specific feedback reports detailing transplant referral data for their center compared to state average
  5. Formulate a facility-specific improvement plan to increase transplant referrals.
  6. Requirement to form a Patient and Family Advisory Group to increase outreach about transplant education within the facility.
  7. Monthly monitoring and reporting of patient referrals to ESRD Network
  8. Conduct a patient and family education session about transplantation
  9. Host a movie day to show Living ACTS (About Choices in Transplantation & Sharing) video


Outcome Measures
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Primary Outcome Measures :
  1. Referral for Kidney Transplantation [ Time Frame: One Year ]
    Following a multicomponent intervention at the dialysis facility level, change in referral for kidney transplantation from baseline to follow-up (at one year) will be calculated.


Secondary Outcome Measures :
  1. Reduction in Racial Disparity [ Time Frame: One Year ]
    Following a multicomponent intervention at the dialysis facility level, reduction in racial disparity (African American vs. Caucasian) of referral for transplantation (from baseline to one year follow up) will be calculated.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Dialysis facilities within GA were considered for this intervention due to data restrictions. The remaining facilities were selected in a step-wise selection process 1) The presence of a racial disparity in referral or 2) a crude referral risk less than six percent.
  • The presence of a racial disparity was based on the crude referral risk difference and the standardized referral risk difference.
  • The remaining facilities had a calculated 6-month crude referral risk mean of 0.06 and all facilities with a crude referral risk less than the mean were selected for inclusion.
  • The final pool of 134 facilities were randomized to either the intervention or control group using a one to one ratio.

Exclusion:

  • Facilities with a 6-month population (from June-December 2012) of less than 13 End Stage Renal Disease patients <70 years of age within a facility were excluded.
Contacts and Locations
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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): NCT02092727


Locations
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United States, Georgia
Dialysis Facilities throughout the State of Georgia, ESRD Network 6
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Rachel E Patzer, PhD, MPH Emory University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rachel Patzer, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02092727    
Other Study ID Numbers: IRB00056381
1R24MD008077-01 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Keywords provided by Rachel Patzer, PhD, Emory University:
Dialysis facilities
African Americans
Racial disparity
Kidney Transplantation
 Community-based Participatory Research
Coalition
Georgia
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases