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Open Access Study protocol

Protocol of a Randomized Controlled Trial of Culturally Sensitive Interventions to Improve African Americans' and Non-African Americans' Early, Shared, and Informed Consideration of Live Kidney Transplantation: The talking about Live Kidney Donation (TALK) study

L Ebony Boulware123*, Felicia Hill-Briggs134, Edward S Kraus5, J Keith Melancon6, Raquel McGuire7, Bobbie Bonhage7, Mikiko Senga3, Patti Ephraim23, Kira E Evans3, Brenda Falcone7, Misty U Troll13, Nicole Depasquale4 and Neil R Powe8

Author Affiliations

1 Division of General Internal Medicine, Department of Medicine, Johns Hopkins School of Medicine, 2024 E. Monument Street, Baltimore, MD 21205, USA

2 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, Maryland 21205, USA

3 Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, 2024 E. Monument Street, Baltimore, Maryland, 21205, USA

4 Department of Health Behavior and Society, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, Maryland 21205, USA

5 Division of Nephrology, Department of Medicine, Johns Hopkins School of Medicine, 1830 E. Monument Street, Baltimore, Maryland, 21287, USA

6 Division of Transplant Surgery, Department of Surgery, Georgetown University Hospital, 3800 Reservoir Road, NW | Washington DC, 20007, USA

7 National Kidney Foundation of Maryland, 1107 Kenilworth Drive, Baltimore, Maryland, 21204, USA

8 University of California San Francisco and San Francisco General Hospital, 1001 Potrero Avenue, San Francisco, California 94110, USA

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BMC Nephrology 2011, 12:34  doi:10.1186/1471-2369-12-34

Published: 8 July 2011

Abstract

Background

Live kidney transplantation (LKT) is underutilized, particularly among ethnic/racial minorities. The effectiveness of culturally sensitive educational and behavioral interventions to encourage patients' early, shared (with family and health care providers) and informed consideration of LKT and ameliorate disparities in consideration of LKT is unknown.

Methods/Design

We report the protocol of the Talking About Live Kidney Donation (TALK) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test culturally sensitive interventions to improve patients' shared and informed consideration of LKT. Study Phase 1 involved the evidence-based development of culturally sensitive written and audiovisual educational materials as well as a social worker intervention to encourage patients' engagement in shared and informed consideration of LKT. In Study Phase 2, we are currently conducting a randomized controlled trial in which participants with progressing chronic kidney disease receive: 1) usual care by their nephrologists, 2) usual care plus the educational materials, or 3) usual care plus the educational materials and the social worker intervention. The primary outcome of the randomized controlled trial will include patients' self-reported rates of consideration of LKT (including family discussions of LKT, patient-physician discussions of LKT, and identification of an LKT donor). We will also assess differences in rates of consideration of LKT among African Americans and non-African Americans.

Discussion

The TALK Study rigorously developed and is currently testing the effectiveness of culturally sensitive interventions to improve patients' and families' consideration of LKT. Results from TALK will provide needed evidence on ways to enhance consideration of this optimal treatment for patients with end stage renal disease.

Trial Registration

ClinicalTrials.gov number, NCT00932334