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

Primary Purpose

Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Interventions for Dialysis Facilities
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Disease focused on measuring Dialysis facilities, African Americans, Racial disparity, Kidney Transplantation, Community-based Participatory Research, Coalition, Georgia

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dialysis Facilities throughout the State of Georgia, ESRD Network 6

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Behavioral Intervention

Arm Description

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.

A variety of dialysis facility-level, behavioral interventions will be examined.

Outcomes

Primary Outcome Measures

Referral for Kidney Transplantation
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

Reduction in Racial Disparity
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.

Full Information

First Posted
March 13, 2014
Last Updated
February 20, 2018
Sponsor
Emory University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02092727
Brief Title
The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
Acronym
RaDIANT
Official Title
The Reducing Disparities in Access to kidNey Transplantation (RaDIANT) Community Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease
Keywords
Dialysis facilities, African Americans, Racial disparity, Kidney Transplantation, Community-based Participatory Research, Coalition, Georgia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Behavioral Intervention
Arm Type
Experimental
Arm Description
A variety of dialysis facility-level, behavioral interventions will be examined.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Interventions for Dialysis Facilities
Intervention Description
Educational seminars and monthly educational webinars Peer-to-peer mentoring program Bulletin boards about transplantation Facility-specific feedback reports detailing transplant referral data for their center compared to state average Formulate a facility-specific improvement plan to increase transplant referrals. Requirement to form a Patient and Family Advisory Group to increase outreach about transplant education within the facility. Monthly monitoring and reporting of patient referrals to ESRD Network Conduct a patient and family education session about transplantation Host a movie day to show Living ACTS (About Choices in Transplantation & Sharing) video
Primary Outcome Measure Information:
Title
Referral for Kidney Transplantation
Description
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.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Reduction in Racial Disparity
Description
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.
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel E Patzer, PhD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dialysis Facilities throughout the State of Georgia, ESRD Network 6
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29334900
Citation
Hamoda RE, Gander JC, McPherson LJ, Arriola KJ, Cobb L, Pastan SO, Plantinga L, Browne T, Hartmann E, Mulloy L, Zayas C, Krisher J, Patzer RE. Process evaluation of the RaDIANT community study: a dialysis facility-level intervention to increase referral for kidney transplantation. BMC Nephrol. 2018 Jan 15;19(1):13. doi: 10.1186/s12882-017-0807-z.
Results Reference
derived
PubMed Identifier
25348614
Citation
Patzer RE, Gander J, Sauls L, Amamoo MA, Krisher J, Mulloy LL, Gibney E, Browne T, Plantinga L, Pastan SO; Southeastern Kidney Transplant Coalition. The RaDIANT community study protocol: community-based participatory research for reducing disparities in access to kidney transplantation. BMC Nephrol. 2014 Oct 28;15:171. doi: 10.1186/1471-2369-15-171.
Results Reference
derived

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

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