Title 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

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 * Correspondence: lboulwa@jhmi.edu Division of General Internal Medicine, Department of Medicine, Johns Hopkins School of Medicine, 2024 E. Monument Street, Baltimore, MD 21205, USA Full list of author information is available at the end of the article Boulware et al. BMC Nephrology 2011, 12:34 http://www.biomedcentral. com/1471-2369/12/34 © 2011 Boulware et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background Living related kidney transplantation (LKT) represents an optimal strategy for the treatment of patients with end stage renal disease (ESRD), offering recipients substantially improved length and quality of life when compared to patients receiving dialysis [1]. However, evidence suggests LKT has been consistently underutilized, particularly among ethnic/racial minorities, who have been demonstrated to be up to 50% less likely than non-minorities to receive LKT [2]. Underutilization of LKT has been attributed, in part, to potential recipients’ lack of knowledge about LKT [3,4], denial about the need to consider LKT [5], difficulties approaching and identifying donors [6], potential recipients’ fears regarding the health of potential donors [7], mistrust of health care and concerns about surgery [8], and suboptimal discussions about LKT between potential recipients, their families, and health care providers [9]. Little is known about effective strategies for improving patients’ and families’ early consideration of LKT. Consideration of LKT prior to patients’ development of ESRD could provide time for both recipients and potential donors (often family members) to fully consider the risks and benefits of LKT, enhancing the probability that their decisions regarding pursuit of LKT align with their personal values. Early consideration of LKT may be particularly important in facilitating and preparing for pre-emptive (before the start of dialysis) LKT– which is associated with the most superior clinical outcomes [10]. Despite this, studies show most patients, particularly ethnic/racial minorities, do not consider LKT as a treatment option until after they have initiated hemodialysis, and that family and physician discussions about LKT are often suboptimal even when patients report they desire LKT as a treatment [3,9]. Patients who have not yet progressed to ESRD may have unique barriers to considering LKT, including their lack of awareness of the severity of their kidney disease [11] and low perceived susceptibility to kidney disease progression and ESRD [12]. Evidence suggests patients with progressing kidney disease and their families, particularly ethnic/racial minorities, may also have avoidant coping strategies which hinder their collaborative decision making [5]. Patients may also feel they have inadequate skills to initiate discussions about LKT with their families and health care providers, further limiting opportunities for early consideration of LKT [13]. Studies assessing the effectiveness of culturally sensitive approaches to improve patients’ early shared, and informed consideration of LKT are needed. We describe the protocol for a two phase study in which we 1) developed culturally sensitive educational and behavioral interventions to improve patients’ early, shared, and informed consideration of LKT and 2) are currently testing the effectiveness of these interventions to improve patients’ consideration of LKT in a randomized controlled trial.