Clinical trial NCT03354910: House Calls and Peer Mentorship
Official title: Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
End-Stage Renal Disease
Keywords: Live Donor Kidney Transplantation
LDKT
Disparity
African American
Education
Patient Support
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Patient-Centered Outcomes Research Institute
First posted: 2017-11-28
Enrollment: 320
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment assignments will be based on a computer-generated randomization scheme, stratified by age (\<60 vs. ≥60 yrs old) and household income (\<250% vs. ≥250% of federal poverty guidelines), since older and low-income patients are known to have lower LDKT rates a priori. Patients will be randomized into one of three treatment arms in a 1:3:3 fashion such that 54 Usual Care, 160 HC and 160 HC+PM patients will be enrolled. The study investigators and research assistants conducting the study assessments of patients will remain blinded to the treatment assignments. KT candidates will be informed of group assignment immediately after completing the Baseline assessment.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Live donor kidney transplants
timeFrame: 1 Year Post-Intervention
Secondary outcomes:
measure: Live donor evaluations
timeFrame: 1 Year Post-Intervention
measure: Live donor inquiries
timeFrame: 1 Year Post-Intervention
Other outcomes:
measure: Improvement in live donor kidney transplant knowledge measured through Living Donation Kidney Transplant Knowledge (LDKT-K) scale score
timeFrame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
measure: Improvement in live donor kidney transplant readiness measured through Living Donation Kidney Transplant Readiness scale (LDKT-R) score
timeFrame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
measure: Reduced health care mistrust measured through Health Care Distrust Scale (HCDS) score
timeFrame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
measure: Reduced live donor kidney transplant concerns measured through measured Living Donation Kidney Transplant Concerns scale (LDKT-C) score
timeFrame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
measure: Greater amount of time spent discussing LDKT and higher quality interactions measured through the Talking About Living Donation (TaLKeD) instrument
timeFrame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
measure: Improvement in self-efficacy discussing LDKT measured through Living Donation Kidney Transplant Self-Efficacy scale (LDKT-SE) score
timeFrame: Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: James R Rodrigue, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: