House Calls and Peer Mentorship

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Disease, End-Stage Renal Disease

Intervention / Treatment
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* Behavioral: House Call
* Behavioral: Peer Mentorship


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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. | |
| Active Comparator: Usual Care (UC) + House Calls (HC)<br>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. | Behavioral: House Call<br>* 60 to 90 minute home based educational intervention which will be administered by a health educator.<br>|
| Experimental: UC + HC + Peer Mentorship<br>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. | Behavioral: House Call<br>* 60 to 90 minute home based educational intervention which will be administered by a health educator.<br>Behavioral: Peer Mentorship<br>* A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live donor kidney transplants | The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants after 1 year. | 1 Year Post-Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live donor evaluations | A secondary outcome for the study is the proportion of enrolled patients with a live donor evaluation at the one-year endpoint. A live donor evaluation is defined as the completion of a transplant evaluation to determine whether a potential living donor is eligible to donate. | 1 Year Post-Intervention | 
| Live donor inquiries | A secondary outcome for the study is proportion of enrolled patients with live donor inquiries at the one-year endpoint. A live donor inquiry is when an individual contacts the transplant center to express interest in living donation, regardless of when they complete the entire live donor evaluation. | 1 Year Post-Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Live Donor Kidney Transplantation, LDKT, Disparity, African American, Education, Patient Support