Living Kidney Donor Lost Wages Trial

NCT03268850 | Completed DMC

• 1 other identifier: 2017P000213
• Study Type: interventional
• Target: 453
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases

Keywords

LDKT; Live donor transplantation; Kidney transplantation

Outcome Measures

Primary Outcomes (3)

• Effectiveness of wage reimbursement on LDKT rate

  LDKT rate in KT candidates compared to historical matched control group

  1 year

• Effect of wage reimbursement on racial disparities in LDKT

  LDKT rate among minorities

  1 year

• 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

Study Arms (2)

LW-A

EXPERIMENTAL

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.

Other: Standard of Care; Behavioral: Wage Reimbursement A

LW-B

EXPERIMENTAL

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.

Other: Standard of Care; Behavioral: Wage Reimbursement B

Interventions

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.

LW-A; LW-B

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.

LW-A

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.

LW-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

BIDMC Transplant Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 31, 2017
• Study Start: February 5, 2018
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)