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Clinical Trials/NCT03354910
NCT03354910CompletedNot Applicable

Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation

Beth Israel Deaconess Medical Center4 sites in 1 country320 target enrollmentStarted: April 30, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
320
Locations
4
Primary Endpoint
Live donor kidney transplants

Study Overview

Brief Summary

Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life benefit for those with late-stage chronic kidney disease. However, minorities, especially blacks, are much less likely to receive LDKT than whites. Given the shortage of deceased donor organs, interventions expanding access to LDKT are needed, particularly for minority patients. House Calls (HC), an educational intervention developed by this study's PI has been shown to be an effective program for raising rates of live donation, especially for black patients. While the HC program has shown outstanding results, participant feedback suggested that follow-up may provide even more benefits. Previous research suggests that peer mentorship (PM) from former or current patients with ESRD may be effective in raising rates of living donation. As such, peer mentorship programs may act as an effective follow-up for HC participants. This study will examine the impact of the HC intervention combined with the peer mentorship program of the National Kidney Foundation on rates of live donor kidney transplantation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Black race (including possible Cape Verdean, Haitian, Dominican)
  • ≥18 yrs old
  • English speaking
  • Meets eligibility criteria for kidney transplant evaluation
  • Ability to provide informed consent
  • Resides within 1.5 hr drive of HC educator

Exclusion Criteria

  • Temporarily Unavailable (TU) on the waiting list and TU is likely to exceed 6 months based on judgement of kidney transplant team
  • Awaiting combined kidney-liver transplantation
  • Awaiting simultaneous pancreas-kidney transplantation
  • Participation in another study to increase the likelihood of LDKT
  • Prior participation in a transplant HC
  • Prior or current participation in the NKF PM program

Arms & Interventions

Usual Care

No Intervention

All enrolled patients will receive Usual Care for transplant candidates at our two centers, which includes individual meetings with transplant providers, attendance at a patient group education session in the transplant center (focused on the specifics of the transplant experience), and a transplant education binder.

UC + HC + Peer Mentorship

Experimental

Patients in this condition will receive the Usual Care and the House Calls intervention as described previously. In addition, participants will receive access to a Peer Mentor trained by the National Kidney Foundation following their House Call.

Intervention: House Call (Behavioral)

Usual Care (UC) + House Calls (HC)

Active Comparator

Patients and their invited guests will be scheduled for one House Call. A house call is meeting done at a patient's home with transplant health educators facilitating a discussion on topics related to living kidney donation. Patients and guests also receive an information packet containing several brochures providing information about the living donation process, common concerns and misperceptions, and donation resources and information about our transplant center (e.g., copy of our quarterly newsletter, contact information). Patients in the group will also receive Usual Care, the regular education on living donation, provided as part of their routine transplant care.

Intervention: House Call (Behavioral)

UC + HC + Peer Mentorship

Experimental

Patients in this condition will receive the Usual Care and the House Calls intervention as described previously. In addition, participants will receive access to a Peer Mentor trained by the National Kidney Foundation following their House Call.

Intervention: Peer Mentorship (Behavioral)

Outcomes

Primary Outcomes

Live donor kidney transplants

Time Frame: 1 Year Post-Intervention

The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants after 1 year.

Secondary Outcomes

  • Live donor evaluations(1 Year Post-Intervention)
  • Live donor inquiries(1 Year Post-Intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

James Rodrigue

Professor of Psychology in the Department of Psychiatry

Beth Israel Deaconess Medical Center

Study Sites (4)

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