Promoting Increases in Living Donation Via Tele-navigation (PILOT) (PILOT)

We hypothesize that expansion of the Living Donor Navigator (LDN) program to include tele-health delivery will overcome geographic disparities in access and facilitate sustained increases in living donation. We will utilize an individually randomized group trial (IRGT) design with delayed intervention initiation to compare the effectiveness of tele-health LDN model to standard of care.

Study Overview

• Status: Enrolling by invitation
• Conditions: Kidney Diseases
• Intervention / Treatment: Behavioral: Living Donor Navigator Program

Detailed Description

Transplant candidate-related and potential living donor-related factors, including difficulty asking family/friends to donate on one's behalf and lack of knowledge about the donation process, respectively, have been implicated in lower donation rates. The investigators will conduct an individually randomized group trial (IRGT) with delayed intervention initiation allowing for: (1) scalability/ implementation in a less resource-intensive fashion compared to traditional randomized trials; (2) Avoid self-selection bias as all participants ultimately participate in the intervention. The LDN Program combines advocacy-training to overcome barriers in initiating conversations with and identification of potential living donors with the use of non-clinical navigators to guide donors through the evaluation process. Participants will be randomized to one of two arms; Arm 1 includes the LDN program via in-person modality, and Arm 2 includes the LDN program via tele-health modality. The investigators primary objective is to demonstrate the effectiveness of these interventions in increasing living donation.

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• End-stage kidney disease (ESKD) patients who are ≥ 18 years old and have initiated evaluation for kidney transplantation.
• If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the study and may still benefit from identification of new donors or increased comfort accepting donation from others.
• Candidates must be English-speaking or deaf with an interpreter.

Exclusion Criteria:

• Individuals under the age of 18 will be excluded from the study.
• Individuals who are not English speaking will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Living Donor Navigator Program In-person; The LDN program is designed to help transplant candidates find potential donors, and guide potential living donors through the evaluation/ donation process. The LDN program consists of four educational sessions, with each session building on the last. Each educational session lasts approximately 2 hours and is held once every other week for two months. Each LDN session will be conducted by a living donor navigator. As potential living donors are identified, the living donor navigators will work closely with the potential donors to guide them through each step of the evaluation/donation process to ensure streamlined medical services and a personalized experience. Individuals randomized to LDN in-person will receive the program locally at the transplant center.	Behavioral: Living Donor Navigator Program; The investigators have developed a 4-session educational program that simultaneously addresses potential donor concerns with the evaluation/donation process and provides advocacy training to transplant candidates and their advocates.
Active Comparator: Living Donor Navigator Program Tele-health; The LDN program is designed to help transplant candidates find potential donors, and guide potential living donors through the evaluation/ donation process. The LDN program consists of four educational sessions, with each session building on the last. Each educational session lasts approximately 2 hours and is held once every other week for two months. Each LDN session will be conducted by a living donor navigator. As potential living donors are identified, the living donor navigators will work closely with the potential donors to guide them through each step of the evaluation/donation process to ensure streamlined medical services and a personalized experience. Individuals randomized to LDN tele-health will receive the program virtually at a local health department within the Alabama Department of Public Health's tele-health network.	Behavioral: Living Donor Navigator Program; The investigators have developed a 4-session educational program that simultaneously addresses potential donor concerns with the evaluation/donation process and provides advocacy training to transplant candidates and their advocates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Live Donor Screenings	The number of living donors screened on behalf of transplant candidates will be collected/ identified through the electronic medical record system.	Within 3 months of condition
Number of Live Donor Approvals	The number of living donor approvals on behalf of transplant candidates will be collected/ identified through the electronic medical record system.	Within 3 months of condition

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Telehealth; Kidney Disease; Virtual; Transplant; Kidney; End Stage Kidney Disease; Living Donation; Remote
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: IRB-300002556; R01DK125509 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No