Living Kidney Donor Lost Wages Trial

Beth Israel Lahey Health

Status: Completed

Conditions: Kidney Diseases

Treatments: Behavioral: Wage Reimbursement A; Other: Standard of Care; Behavioral: Wage Reimbursement B

Study type: Interventional

Funder types: Other

Identifiers

NCT03268850

2017P000213

Details and patient eligibility

About

This study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation.

Full description

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.

Enrollment: 453 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• For LDs:
• Their KT candidate is enrolled in the trial

Exclusion criteria

• 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
• For LDs:
• Not residing in the US

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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453 participants in 2 patient groups

LW-A

Experimental group

Description:

The Lost Wages A (LW-A) arm will be composed of kidney transplant patients meeting the inclusion criteria. This arm allows for possible wage reimbursement of living donor lost wages up to a certain amount. This will also include standard of care.

Treatment:

Behavioral: Wage Reimbursement A

Other: Standard of Care

LW-B

Experimental group

Description:

The Lost Wages B (LW-B) arm will be composed of kidney transplant patients meeting the inclusion criteria. This arm allows for possible wage reimbursement of living donor lost wages up to a different amount. This will also include standard of care.

Treatment:

Behavioral: Wage Reimbursement B

Other: Standard of Care