Transplant Social Worker Support for Live Kidney Donation in African Americans

NCT ID: NCT02369354

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-07-02

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.

Conditions

Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Usual Care

Usual medical care at the Duke Kidney Transplant Clinic

Group Type: NO_INTERVENTION

No interventions assigned to this group

TALKS

Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings

Group Type: OTHER

TALKS Social Worker Intervention

Intervention Type: BEHAVIORAL

TALKS 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.

TALKS PLUS

Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention

Group Type: OTHER

TALKS Social Worker Intervention

Intervention Type: BEHAVIORAL

TALKS 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.

Financial Assistance Intervention

Intervention Type: OTHER

The 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.

Interventions

TALKS Social Worker Intervention

TALKS 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.

Intervention Type: BEHAVIORAL

Financial Assistance Intervention

The 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.

Intervention Type: OTHER

Eligibility Criteria

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

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

For potential live kidney donors (TALKS PLUS arm only)

• 18 or older
• Contact the study
• 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):

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh E Boulware, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke School of Medicine, Division of General Internal Medicine

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33210831 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26452366 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R01DK098759

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00052724

Identifier Type: -

Identifier Source: org_study_id