NCT02092727

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

March 13, 2014

Last Update Submit

February 20, 2018

Conditions

Keywords

Dialysis facilitiesAfrican AmericansRacial disparityKidney TransplantationCommunity-based Participatory ResearchCoalitionGeorgia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reduction in Racial Disparity

    One Year

Study Arms (2)

Control

NO INTERVENTION

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.

Behavioral Intervention

EXPERIMENTAL

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

Behavioral: Behavioral Interventions for Dialysis Facilities

Interventions

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

Behavioral Intervention

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 final pool of 134 facilities were randomized to either the intervention or control group using a one to one ratio.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dialysis Facilities throughout the State of Georgia, ESRD Network 6

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Kidney Diseases

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rachel E Patzer, PhD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 20, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations