Living Donor Wage Reimbursement Trial

项目总结/摘要 肾移植的等待名单（KT）现在超过100，000，在一些地区等待时间超过7年 美国地区活体供肾移植（LDKT）加速了移植的进程， 上级结局优于透析和死亡供体KT。然而，每年LDKT的数量 在过去的十年中，特别是在少数民族和低收入患者中。我们假设， 初步数据支持，对活体捐赠者（LDs）的财务影响是LDKT的主要贡献者 这是由于低出生率、低死亡率和低死亡率之间持续存在的种族差异。许多LD有大量的非报销直接 和间接费用，最明显的是手术后的收入或工资损失。在本研究中，我们将：（1） 评估以最低工资标准补偿劳工处工资损失的成效;（2）研究 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）确定是否 研究结果因LD损失工资的最高补偿金额而存在显著差异。完成 这些目标，我们将进行一项混合随机试验和匹配的历史对照研究， 入组350名KT受试者，随机分配至两个平行组之一：（1）可能 补偿劳工处损失的工资，最高可达$1，500（LW-1.5），或（2）可补偿劳工处损失的工资，最高可达$1，500（LW-1.5） 3 000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率总体上相对于匹配的历史对照，和（B）减少LDKT率之间的差异， 白色和少数民族患者相对于历史模式。此外，我们假设，KT候选人谁是 提供高达3,000美元的补偿LD损失的工资将有更高的可能性LDKT相比， 为劳工处的工资损失提供高达1，500元的补偿。最后，我们将评估提供 发还劳工处在KT候选人及准劳工处处长的决策过程中所损失的工资，以及 压力/胁迫和决策稳定性的感知。总的来说，拟议的研究将是第一个 实证研究提供工人处工资损失补偿对KT候选人的意愿的影响 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 将是第一个研究对这些结果的不同影响，提供补偿劳工处损失的工资， 不同的金额（1,500美元对3,000美元）捐赠后。因此，这项研究的结果具有很高的潜力， 影响政策，临床实践，LDKT获取，以及KT中已知的收入和种族差异。组装的 跨学科研究团队有着长期的合作记录，并在国际上得到认可， 制定创新战略，增加弱势患者群体获得LDKT的机会， 资助进行大型RCT和多中心研究，并广泛传播研究结果 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.