Clinical Trials Directory

Trials / Completed

CompletedNCT02369354

Transplant Social Worker Support for Live Kidney Donation in African Americans

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
300 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTALKS Social Worker InterventionTALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
OTHERFinancial Assistance InterventionThe financial assistance intervention offers potential donors the ability to draw from a "bank" of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.

Timeline

Start date
2015-09-01
Primary completion
2019-07-02
Completion
2019-07-02
First posted
2015-02-23
Last updated
2023-07-05
Results posted
2023-07-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02369354. Inclusion in this directory is not an endorsement.