Clinical trial NCT05468463: Promoting Increases in Living Donation Via Tele-navigation (PILOT)
Official title: Promoting Increases in Living Donation Via Tele-navigation (PILOT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Diseases
Keywords: Kidney Disease
Kidney
End Stage Kidney Disease
Living Donation
Telehealth
Transplant
Remote
Virtual
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-07-21
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number Live Donor Screenings
timeFrame: Within 3 months of condition
measure: Number of Live Donor Approvals
timeFrame: Within 3 months of condition
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Vineeta Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: