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

Kidney Disease Clinical Trial

— RaDIANT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092727
• Other study ID #: IRB00056381
• Secondary ID: 1R24MD008077-01
• Status: Completed
• Phase: N/A
• First received: March 13, 2014
• Last updated: February 20, 2018
• Start date: February 2014
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: January 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Intervention

Behavioral:
• Behavioral Interventions for Dialysis Facilities
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

Locations

Country	Name	City	State
United States	Dialysis Facilities throughout the State of Georgia, ESRD Network 6	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One Year
Secondary	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.	One Year