Living Kidney Donor Lost Wages Trial

Kidney Diseases Clinical Trial

Official title:

Living Donor Lost Wages Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268850
• Other study ID #: 2017P000213
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Other:
• Standard of Care
All patients participating in the study will continue to receive usual care. Kidney transplant (KT) candidates are advised that live donor kidney transplantation (LDKT) is their best treatment option and are encouraged to initiate living donor (LD) discussions with family members and friends.

Behavioral:
• Wage Reimbursement A
Enrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount, based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages. Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria.
• Wage Reimbursement B
Enrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount (different from LW-A), based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages. Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria.

Locations

Country	Name	City	State
United States	BIDMC Transplant Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of wage reimbursement on LDKT rate	LDKT rate in KT candidates compared to historical matched control group	1 year
Primary	Effect of wage reimbursement on racial disparities in LDKT	LDKT rate among minorities	1 year
Primary	Difference between reimbursement arms	LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm	1 year