House Calls and Peer Mentorship

NCT03354910 | Completed

• 2 other identifiers: 2017P000521PCORI 1609-36589
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Disease; End-Stage Renal Disease

Keywords

Live Donor Kidney Transplantation; LDKT; Disparity; African American; Education; Patient Support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Live donor evaluations

  1 Year Post-Intervention

• Live donor inquiries

  1 Year Post-Intervention

Other Outcomes (6)

• Improvement in live donor kidney transplant knowledge measured through Living Donation Kidney Transplant Knowledge (LDKT-K) scale score

  Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

• Improvement in live donor kidney transplant readiness measured through Living Donation Kidney Transplant Readiness scale (LDKT-R) score

  Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

• Reduced health care mistrust measured through Health Care Distrust Scale (HCDS) score

  Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

Study Arms (3)

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.

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.

Behavioral: House Call

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.

Behavioral: House Call; Behavioral: Peer Mentorship

Interventions

House Call BEHAVIORAL

60 to 90 minute home based educational intervention which will be administered by a health educator.

UC + HC + Peer Mentorship; Usual Care (UC) + House Calls (HC)

Peer Mentorship BEHAVIORAL

A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.

UC + HC + Peer Mentorship

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Medical University of South Carolina: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

House Calls

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• James R Rodrigue, Ph.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology in the Department of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 28, 2017
• Study Start: April 30, 2018
• Primary Completion: March 31, 2021
• Study Completion: December 18, 2022
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (2)