Kidney Diseases
Conditions
Keywords
Kidney Disease, Kidney, End Stage Kidney Disease, Living Donation, Telehealth, Transplant, Remote, Virtual
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.
Interventions
BEHAVIORALLiving 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.
Sponsors
University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Live Donor Screenings | Within 3 months of condition | The number of living donors screened on behalf of transplant candidates will be collected/ identified through the electronic medical record system. |
| Number of Live Donor Approvals | Within 3 months of condition | The number of living donor approvals on behalf of transplant candidates will be collected/ identified through the electronic medical record system. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVineeta Kumar, MD
University of Alabama at Birmingham
Outcome results
None listed