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待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，并且接受活体肾移植（LDKT）的可能性要小得多。虽然教育工作有助于提高患有 ESRD 的非裔美国人对 LDKT 的必要性和益处的认识，但很少有人尝试系统地研究在该患者群体中增加 LDKT 的策略。该研究计划的长期目标是改善向非裔美国人提供的教育，从而提高 LDKT 率。本应用的目的是确定提高非裔美国人 LDKT 率的三种策略的相对有效性。中心假设是，相对于移植中心提供的教育干预措施，涉及患者和重要其他人的家庭干预措施在非裔美国人群体中产生更高的 LDKT 率。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患者的临床有效性； 2) 确定与追求 LDKT 密切相关的社会人口统计学、医疗和捐赠特定变量。一百八十名患有终末期肾病 (ESRD) 的非洲裔美国成年人将被随机接受三种教育干预措施之一：家庭 (HB)、团体 (GB) 或标准护理 (SC)。 HB（家庭）和 GB（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）反映了该移植中心目前所做的事情，并且仅向个别患者提供教育。主要结局是接受 LDKT 的患者比例。次要结果包括活体捐赠者询问、活体捐赠者评估、受教育的潜在活体捐赠者数量以及 LDKT 知识、担忧和意愿。将收集招募率、流失率、不参与和流失的原因、协议遵守情况和参与者满意度评级。拟议的研究具有创新性，因为它评估了旨在提高非裔美国人 LDKT 率的三种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距，肾移植中心可以使用这些策略来提高非裔美国人的 LDKT 率。该提案直接涉及 HealthyPeople2010 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).