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Living Kidney Donor Lost Wages Trial

Primary Purpose

Kidney Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Wage Reimbursement A
Wage Reimbursement B
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Diseases focused on measuring LDKT, Live donor transplantation, Kidney transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BIDMC Transplant Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LW-A

LW-B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effectiveness of wage reimbursement on LDKT rate
LDKT rate in KT candidates compared to historical matched control group
Effect of wage reimbursement on racial disparities in LDKT
LDKT rate among minorities
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

Secondary Outcome Measures

Full Information

First Posted
August 22, 2017
Last Updated
January 31, 2023
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03268850
Brief Title
Living Kidney Donor Lost Wages Trial
Official Title
Living Donor Lost Wages Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
LDKT, Live donor transplantation, Kidney transplantation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Care ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LW-A
Arm Type
Experimental
Arm Description
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.
Arm Title
LW-B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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
Behavioral
Intervention Name(s)
Wage Reimbursement A
Intervention Description
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
Intervention Name(s)
Wage Reimbursement B
Intervention Description
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 Outcome Measure Information:
Title
Effectiveness of wage reimbursement on LDKT rate
Description
LDKT rate in KT candidates compared to historical matched control group
Time Frame
1 year
Title
Effect of wage reimbursement on racial disparities in LDKT
Description
LDKT rate among minorities
Time Frame
1 year
Title
Difference between reimbursement arms
Description
LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
BIDMC Transplant Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Living Kidney Donor Lost Wages Trial

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