Clinical trial NCT02369354: Transplant Social Worker Support for Live Kidney Donation in African Americans
Official title: Transplant Social Worker Support for Live Kidney Donation in African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Disease
Keywords: Kidney Transplant
African Americans
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-02-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education, behavior, and financial support interventions to improve consideration of live kidney transplantation/live kidney donation among African Americans on the deceased kidney waiting list. We hypothesize that interventions to help potential kidney transplant recipients and their potential donors overcome barriers to live donor kidney transplant (including family discussions, financial, or logistical barriers) could improve potential recipients' receipt of live kidney transplants. The main outcomes of TALKS will include whether potential recipients (1) have potential live donors call into the transplant center on their behalf; (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney transplant.

Detailed description: Live donor kidney transplantation (LDKT) represents an optimal therapy for many patients. However, African Americans have been persistently and significantly less likely to receive LDKT when compared to Whites. The process of seeking and establishing a live donor for LDKT requires potential donors overcome several potential obstacles to LKDT. As a critical first step to seeking LDKT, patients must engage their physicians and their family members or friends (who provide support for patients' health decisions and could also be potential donors) in discussions about LDKT to determine whether LDKT is a viable and/or desirable treatment option. LDKT discussions with physicians help patients and family members understand the risks and benefits of LDKT to both the potential recipient and any potential donors. Families' LDKT discussions help them establish whether it is possible to identify willing and medically eligible live donors, and they help families discuss the potential psychological, physical, and financial strains of LDKT on patients and families. Once discussions have occurred, potential donors must confront logistical (e.g., childcare or travel to transplant centers) and financial (e.g., unpaid time away from work) challenges associated with LDKT. Studies have shown that even when African American patients desire LDKT, rates of LDKT discussions are suboptimal. Further, African American potential live kidney donors are less likely than their White counterparts to complete the donor evaluation process, and they may be more sensitive than Whites to logistical and financial barriers to LDKT. Innovative strategies to overcome interpersonal, logistical and financial barriers to LDKT are sorely needed for African Americans, particularly those who may be highly motivated to seek this therapy. Transplant social workers routinely perform psychosocial evaluations on potential LDKT recipients and donors and are well suited to support families' navigation of LDKT discussions. Transplant social workers are also well versed in the financial aspects of LDKT (e.g., insurance coverage rules) and frequently provide financial guidance to potential LDKT recipients and donors. We will study innovative transplant social worker led interventions designed to help African American potential LDKT recipients and their families overcome interpersonal, logistical and financial barriers to LDKT. African Americans on the deceased kidney donor waiting list will be randomly assigned to (1) receive their usual care on the transplant list or (2) to one of two social worker led interventions-one which helps patients and families discuss LDKT with each other and with patients' physicians, and one which provides families with financial support to overcome logistical and financial barriers to LDKT. As a primary outcome, we will measure whether the interventions activate live kidney donation on African American potential recipients' behalf.

Eligibility criteria: For potential kidney transplant recipients (all arms):

Inclusion Criteria:

* Adult (18 yrs or older)
* African American
* Duke Kidney and Pancreas Transplant patients with end stage kidney disease
* Currently on the deceased donor kidney waiting list from the Duke Kidney and Pancreas Transplant Program
* Give consent to participate

Exclusion Criteria:

* Previous kidney transplant (Revised Sept 2016: persons who have previously received a deceased donor kidney transplant, but who have not previously received a live donor kidney transplant)
* Cognitively impaired/Change in cognition
* Impaired hearing or speech
* Non-English speaking

For family members or friends of potential kidney transplant recipients (TALK and TALK PLUS arms):

Inclusion Criteria:

* 18 or older
* Come to SWI meeting with patient
* Give consent to participate

For potential live kidney donors (TALKS PLUS arm only)

Inclusion Criteria:

* 18 or older
* Contact the study
* Give consent to participate

Primary outcomes:
measure: Number of Participants With Live Kidney Donor Activation Events
timeFrame: 24 months post randomization
Secondary outcomes:
measure: Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation
timeFrame: 24 months post randomization
measure: Number of Participants With Live Donor Evaluations
timeFrame: 24 months post randomization
measure: Number of Participants With Live Kidney Donor Transplants
timeFrame: 24 months post randomization
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke School of Medicine, Division of General Internal Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Leigh E Boulware, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boulware LE, Sudan DL, Strigo TS, Ephraim PL, Davenport CA, Pendergast JF, Pounds I, Riley JA, Falkovic M, Alkon A, Hill-Briggs F, Cabacungan AN, Barrett TM, Mohottige D, McElroy L, Diamantidis CJ, Ellis MJ. Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial. Am J Transplant. 2021 Jun;21(6):2175-2187. doi: 10.1111/ajt.16403. Epub 2021 Jan 4.
citation: Strigo TS, Ephraim PL, Pounds I, Hill-Briggs F, Darrell L, Ellis M, Sudan D, Rabb H, Segev D, Wang NY, Kaiser M, Falkovic M, Lebov JF, Boulware LE. The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: protocol of a randomized clinical trial. BMC Nephrol. 2015 Oct 9;16:160. doi: 10.1186/s12882-015-0153-y.