Living Kidney Donor Lost Wages Trial

NCT ID: NCT03268850

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

453 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Candidates will be randomized 1:1 to the LW-A or LW-B arm, with stratification for race. The investigators will prepare the randomization schedule using permuted blocks of randomly varying size to limit predictability and imbalances in arm assignment throughout the study. KT candidates will be informed of group assignment immediately after consenting to the study.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators
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.

Study Groups

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LW-A

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.

Group Type EXPERIMENTAL

Standard of Care

Intervention Type OTHER

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.

Wage Reimbursement A

Intervention Type BEHAVIORAL

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.

LW-B

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.

Group Type EXPERIMENTAL

Standard of Care

Intervention Type OTHER

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.

Wage Reimbursement B

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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James Rodrigue

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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BIDMC Transplant Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2017P000213

Identifier Type: -

Identifier Source: org_study_id

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