Living Donor Lost Wages Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 453
- 试验地点
- 2
- 主要终点
- Difference between reimbursement arms
研究概览
简要总结
This study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation.
详细描述
Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor kidney transplantation (KT). However, the annual number of LDKTs has declined over the last decade, particularly among minority and low-income patients. The investigators 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, the investigators 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Allocation will be concealed from the study investigators; however, research assistants conducting the assessments will not be blinded since the assessment protocol differs based on group assignment. Study participants will know which arm they are in, but not the reimbursement amount of the other arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For KT patients:
- •Chronic Kidney Disease (CKD) stage 4/5
- •Approved for kidney transplant (KT) listing or active on KT waiting list
- •For patients listed at multiple centers: primary listing at Beth Israel Deaconess Medical Center (BIDMC)
- •Their KT candidate is enrolled in the trial
排除标准
- •For KT patients:
- •KT candidate has a potential LD approved, with surgery scheduled
- •Listed for multi-organ transplantation
- •Temporarily unavailable (TU) status on KT waiting list
- •Current enrollment in another study to increase LDKT likelihood
- •Not residing in the US
结局指标
主要结局
Difference between reimbursement arms
时间窗: 1 year
LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm
Effect of wage reimbursement on racial disparities in LDKT
时间窗: 1 year
LDKT rate among minorities
Effectiveness of wage reimbursement on LDKT rate
时间窗: 1 year
LDKT rate in KT candidates compared to historical matched control group
次要结局
未报告次要终点
研究者
James Rodrigue
Primary Investigator
Beth Israel Deaconess Medical Center