MedPath

Living Kidney Donor Lost Wages Trial

Not Applicable
Completed
Conditions
Kidney Diseases
Interventions
Other: Standard of Care
Behavioral: Wage Reimbursement B
Behavioral: Wage Reimbursement A
Registration Number
NCT03268850
Lead Sponsor
Beth Israel Deaconess Medical Center
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
453
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LW-AStandard of CareThe 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.
LW-BWage Reimbursement BThe 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.
LW-BStandard of CareThe 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.
LW-AWage Reimbursement AThe 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.
Primary Outcome Measures
NameTimeMethod
Effect of wage reimbursement on racial disparities in LDKT1 year

LDKT rate among minorities

Difference between reimbursement arms1 year

LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm

Effectiveness of wage reimbursement on LDKT rate1 year

LDKT rate in KT candidates compared to historical matched control group

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

BIDMC Transplant Center

🇺🇸

Boston, Massachusetts, United States

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