search
Back to results

House Calls and Peer Mentorship (HC+PM)

Primary Purpose

Chronic Kidney Disease, End-Stage Renal Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
House Call
Peer Mentorship
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease focused on measuring Live Donor Kidney Transplantation, LDKT, Disparity, African American, Education, Patient Support

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Usual Care

Usual Care (UC) + House Calls (HC)

UC + HC + Peer Mentorship

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 23, 2017
Last Updated
February 6, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Medical University of South Carolina, Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03354910
Brief Title
House Calls and Peer Mentorship
Acronym
HC+PM
Official Title
Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Medical University of South Carolina, Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End-Stage Renal Disease
Keywords
Live Donor Kidney Transplantation, LDKT, Disparity, African American, Education, Patient Support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Usual Care (UC) + House Calls (HC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
UC + HC + Peer Mentorship
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
House Call
Intervention Description
60 to 90 minute home based educational intervention which will be administered by a health educator.
Intervention Type
Behavioral
Intervention Name(s)
Peer Mentorship
Intervention Description
A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.
Primary Outcome Measure Information:
Title
Live donor kidney transplants
Description
The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants after 1 year.
Time Frame
1 Year Post-Intervention
Secondary Outcome Measure Information:
Title
Live donor evaluations
Description
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.
Time Frame
1 Year Post-Intervention
Title
Live donor inquiries
Description
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.
Time Frame
1 Year Post-Intervention
Other Pre-specified Outcome Measures:
Title
Improvement in live donor kidney transplant knowledge measured through Living Donation Kidney Transplant Knowledge (LDKT-K) scale score
Description
An improvement in patient knowledge is measured by the change in score of a scored instrument, the Living Donation Kidney Transplant Knowledge Scale (LDKT-K). The LDKT-K is a scored true or false questionnaire that tests patient's knowledge on living donation. A higher score indicates that a participant answered more questions correctly.
Time Frame
Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Title
Improvement in live donor kidney transplant readiness measured through Living Donation Kidney Transplant Readiness scale (LDKT-R) score
Description
Improvement in patient readiness to pursue LDKT is measured by a scored instrument, the Living Donation Kidney Transplant Readiness Scale (LDKT-R). The LDKT-R is a 5-point scale where patient's self report their readiness to pursue living donation and where in the process they are (i.e., they are beginning to think about living donation, have spoken with potential donors, etc.) A higher score on this assessment indicates greater readiness to pursue LDKT.
Time Frame
Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Title
Reduced health care mistrust measured through Health Care Distrust Scale (HCDS) score
Description
Reduction in patient mistrust towards the health care system is measured through a scale, the Health Care Distrust Scale (HCDS). This scale is a 5-point Likert scale that measures the degree of agreement patients have on statements regarding their trust of the medical system. For example, one such statement reads "the health care systems lie to make money." A higher score on this assessment indicates higher levels of mistrust of the health care system.
Time Frame
Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Title
Reduced live donor kidney transplant concerns measured through measured Living Donation Kidney Transplant Concerns scale (LDKT-C) score
Description
Patient's concerns towards LDKT is measured using a 5-point scale, the Living Donation Kidney Transplant Concerns scale (LDKT-C) where patients indicate their level of concern towards common concerns patients have regarding living donation. A higher score on this assessment indicates higher levels of concern towards living donation.
Time Frame
Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Title
Greater amount of time spent discussing LDKT and higher quality interactions measured through the Talking About Living Donation (TaLKeD) instrument
Description
The time patients speak with others about LDKT and whether these interactions are of higher quality compared to pre-intervention is measured through a self-report instrument, Talking About Living Donation (TaLKeD), that asks the cumulative time patient's spoke with others (family, friends, etc.) about living donation and their perceived quality of these interactions (poor, fair, good, very good, excellent).
Time Frame
Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention
Title
Improvement in self-efficacy discussing LDKT measured through Living Donation Kidney Transplant Self-Efficacy scale (LDKT-SE) score
Description
Patient's self-efficacy towards doing activities to pursue LDKT (e.g. willingness and confidence to approach others for donation, following-up with potential donors) is measured through a self-report instrument, the Living Donation Kidney Transplant Self-Efficacy (LDKT-SE) scale. A higher score on this assessment indicates higher self-efficacy for patients pursuing LDKT.
Time Frame
Baseline, 1 Week Post-Intervention, 6 Weeks Post-Intervention, and 12 Weeks Post-Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Rodrigue, Ph.D.
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

House Calls and Peer Mentorship

We'll reach out to this number within 24 hrs