Living Donor Wage Reimbursement Trial

项目摘要/摘要 肾移植(KT)的等待名单现在超过10万人，有些人的等待时间超过7年 美国地区。活体供肾移植(LDKT)加速了移植的进程并提高了产量 与透析和已故供者KT相比，预后更好。然而，每年LDKT的数量有 在过去十年中，特别是在少数族裔和低收入患者中，这一比例有所下降。我们假设，并有 需要支持的初步数据表明，对在世捐助者的财务影响(LDS)是对LDKT的主要贡献 这是由于儿童死亡率下降以及长期存在的LDKT率种族差异造成的。许多LD有大量未报销的直接费用 以及间接成本，最明显的是手术后收入或工资的损失。在本研究中，我们将：(1) 评估LD损失工资报销的有效性；(2)检查 为LD损失的工资提供补偿减少了LDKT中已知的种族差异；以及(3)确定 研究结果在LD工资损失的最高补偿金额方面存在显著差异。要完成 为了达到这些目的，我们将进行混合随机试验和配对的历史对照研究， 招收350名KT候选人，他们将被随机分配到两个平行的队伍中：(1)可能 退还劳工部损失的工资，最高可达1,500美元(LW-1.5)，或(2)可能补偿最高达1,500美元的劳工部损失工资 3000美元(LW-3.0)。我们的中心假设是，为LD损失的工资提供补偿将(A)产生更高的收益 LDKT比率相对于匹配的历史对照的总体比率，以及(B)减少#年LDKT比率之间的差距 白人和少数民族患者相对于历史模式。此外，我们假设KT候选人是 为LD损失的工资提供高达3,000美元的报销将比那些 为劳工部损失的工资提供高达1,500美元的补偿。最后，我们将评估服务的影响 补偿因KT候选人和潜在LD的决策以及 对压力/胁迫和决策稳定性的看法。总体而言，拟议的研究将是第一个 实证检验提供LD损失工资补偿对KT考生意愿的影响 追踪LDKT、LDKT中的种族差异、LD评估率和实际LDKT率。此外，这项研究还 将首先检查提出补偿LD损失的工资对这些结果的不同影响 捐赠后的不同金额(1,500美元与3,000美元)。因此，这项研究的发现具有很高的潜力。 影响政策、临床实践、LDKT的获得以及KT中已知的收入和种族差异。已组装好的 跨学科研究团队有着长期的合作记录，并在以下方面获得国际认可 制定创新战略，增加弱势患者群体获得LDKT的机会，校外 资助开展大型随机对照试验和多中心研究，并与广泛传播研究成果 政策和临床实践的影响。

PROJECT SUMMARY / ABSTRACT The waiting list for kidney transplantation (KT) now exceeds 100,000 and waiting times exceed 7 yrs in some U.S. regions. Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor KT. However, the annual number of LDKTs has declined over the last decade, particularly among minority and low-income patients. We hypothesize, and have preliminary data to support, that the financial impact on living donors (LDs) is a major contributor to the LDKT decline and for persistent racial disparities in LDKT rates. Many LDs have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. In this study, we will: (1) evaluate the effectiveness of offering reimbursement for LD lost wages on the LDKT rate; (2) examine whether offering reimbursement for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages. To accomplish these aims, we will conduct a blended randomized trial and matched historical control study with a planned enrollment of 350 KT candidates who will be randomized to one of two parallel arms: (1) possible reimbursement of LD lost wages up to $1,500 (LW-1.5), or (2) possible reimbursement of LD lost wages up to $3,000 (LW-3.0). Our central hypotheses are that offering reimbursement for LD lost wages will (a) yield higher LDKT rates overall relative to matched historical controls, and (b) reduce the disparity between LDKT rates in white and minority patients relative to historical patterns. Also, we hypothesize that KT candidates who are offered up to $3,000 reimbursement for LD lost wages will have a higher likelihood of LDKT compared to those offered up to $1,500 of reimbursement for LD lost wages. Finally, we will assess the impact of offering reimbursement for LD lost wages on the decision-making of both KT candidates and potential LDs as well as perceptions of pressure/coercion and decision stability. Overall, the proposed study will be the first to empirically examine the impact of offering LD lost wages reimbursement on the willingness of KT candidates to pursue LDKT, racial disparity in LDKT, rates of LD evaluations, and actual LDKT rates. Moreover, this study will be the first to examine the differential impact on these outcomes of offering to reimburse LD lost wages for different amounts ($1,500 vs. $3,000) after donation. As such, findings from this study have very high potential to impact policy, clinical practice, LDKT access, and known income and racial disparities in KT. The assembled interdisciplinary research team has a long track record of collaboration and is internationally recognized for developing innovative strategies to increase LDKT access in disadvantaged patient populations, extramural funding to conduct large RCTs and multi-center studies, and dissemination of research findings with broad policy and clinical practice implications.