A Randomized Trial and Reduce to Disparity in Live Donor Kidney Transplantation

描述（由申请人提供）： 非裔美国人在肾移植等候名单中所占的比例高于根据人口参数预期的比例，他们等待肾移植的时间更长，而且他们接受活体供肾移植（LDKT）的可能性要小得多。虽然教育工作有助于提高对非裔美国人ESRD患者LDKT的需求和益处的认识，但很少有人尝试系统地研究在该患者人群中增加LDKT的策略。这项研究计划的长期目标是改善为非洲裔美国人提供的教育，从而提高LDKT的比率。本申请的目的是确定增加非裔美国人LDKT率的三种策略的相对有效性。中心假设是，家庭为基础的干预，涉及病人和其他重要的产生更高的LDKT率在非洲裔美国人的人口相对于在移植中心提供的教育干预。在强有力的初步数据的指导下，这一假设将通过追求两个具体目标进行检验：1）确定三种独立的LDKT教育方法对非裔美国人患者的临床有效性; 2）确定与追求LDKT最密切相关的社会人口统计学，医学和捐赠特定变量。180名患有终末期肾病（ESRD）的非洲裔美国成年人将被随机分配接受三种教育干预之一：家庭（HB）、团体（GB）或标准护理（SC）。HB（在家里）和GB（在移植中心）干预措施将为患者及其直系亲属和大家庭成员，重要的其他人和朋友提供教育。SC干预（在移植中心）反映了目前在该移植中心所做的工作，并将仅向个体患者提供教育。主要结局是接受LDKT的患者比例。次要结果包括活体供者询问、活体供者评价、受教育的潜在活体供者数量以及LDKT知识、关注和意愿。将收集招募率、损耗率、不参与和损耗原因、方案依从性和参与者满意度评级。这项研究是创新的，因为它评估了三种旨在提高非裔美国人LDKT率的教育策略的相对有效性。这项研究的结果有可能通过确定基于证据的教育策略来缩小这种种族差异，这些策略可用于肾移植中心提高非裔美国人的LDKT率。该提案直接涉及《2010年人民健康》的三个优先领域（4-1、4-5、4-6）。

DESCRIPTION (provided by applicant): African Americans comprise a higher percentage of the waiting list for kidney transplantation than would be expected based on population parameters, they wait longer for kidney transplantation, and they are far less likely to receive live donor kidney transplantation (LDKT). While educational efforts have helped to expand awareness about the need for and benefits of LDKT among African Americans with ESRD, there have been very few attempts to systematically examine strategies for increasing LDKT in this patient population. The long-term goal of this research program is to improve education provided to African Americans and, thereby, increase rates of LDKT. The objective of this application is to determine the relative effectiveness of three strategies for increasing LDKT rates in African Americans. The central hypothesis is that a home-based intervention that involves the patient and significant others yields higher LDKT rates in an African American population relative to educational interventions delivered in the transplant center. Guided by strong preliminary data, this hypothesis will be tested by pursuing two specific aims: 1) Determine the clinical effectiveness of three separate LDKT educational approaches with African American patients; and 2) Determine the sociodemographic, medical, and donation-specific variables that are most strongly associated with pursuing LDKT. One hundred eighty African American adults with end-stage renal disease (ESRD) will be urn randomized to receive one of three educational interventions: home-based (HB), group-based (GB), or standard care (SC). The HB (in the home) and GB (in the transplant center) interventions will provide education to patients and their immediate and extended family members, significant others, and friends. The SC intervention (in the transplant center) mirrors what is currently done at this transplant center and will provide education to individual patients only. The primary outcome is the proportion of patients who receive LDKT. Secondary outcomes include live donor inquiries, live donor evaluations, number of potential live donors educated, and LDKT knowledge, concerns, and willingness. Recruitment rates, attrition rates, reasons for nonparticipation and attrition, protocol adherence, and participant satisfaction ratings will be gathered. The proposed research is innovative because it evaluates the relative effectiveness of three educational strategies designed to increase LDKT rates in African Americans. Findings from this study have the potential to close this racial disparity gap by identifying evidence-based educational strategies that can be used by kidney transplant centers to increase LDKT rates in African Americans. This proposal directly addresses three of the priority areas of HealthyPeople2010 (4-1, 4-5, 4-6).