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Completed

NCT Number: NCT03268850

Living Kidney Donor Lost Wages Trial

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

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Key information

Conditions

Kidney Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BIDMC Transplant Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

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

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.

Wage Reimbursement B

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.

Primary outcomes

  1. Effectiveness of wage reimbursement on LDKT rate

    Time frame: 1 year

    LDKT rate in KT candidates compared to historical matched control group

  2. Effect of wage reimbursement on racial disparities in LDKT

    Time frame: 1 year

    LDKT rate among minorities

  3. Difference between reimbursement arms

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Living Donor Lost Wages Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2017
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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