Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates

December 13, 2021 updated by: Arbor Research Collaborative for Health

Randomized Controlled Trial to Evaluate the Effect of Lost Wage Reimbursement to Potential Kidney Donors On Living Donation Rates

The study is designed as a randomized controlled trial. The investigators hypothesize that kidney transplant recipient candidates whose donors are offered reimbursement of lost wages (treatment arm) will have a higher probability of receiving a living donor kidney transplant than those randomized to no offer of lost wage reimbursement (control arm). The study expects to demonstrate incremental living donor kidney transplants by assisting individuals who wish to be living organ donors but would be otherwise unable to do so due to the obligatory forfeit of income during the evaluation, donation surgery, and post-operative recuperation periods.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Following confirmation of eligibility and written informed consent to participate in the study, kidney recipient candidates will be randomized at the time of their evaluation appointment to the treatment arm (donor eligible for reimbursement of lost wages) or the control arm (donor not eligible for reimbursement of lost wages).

Consented, randomized recipients will be followed for up to one year from the baseline visit, with no required in-person visits beyond baseline. Data will be collected at baseline, six months after baseline, and one year after baseline. Demographic data (e.g. age, sex, race, ethnicity) will be collected on all recipients during screening and eligibility assessment. At baseline only, we will collect recipient household size, household income, and limited clinical data (on dialysis or not; date of dialysis initiation (if on dialysis); on deceased donor waiting list or not; date of wait-listing if on waiting list). At six months after baseline (and at one year after baseline, if applicable), we will collect recipient outcome data (date of receipt of living donor or deceased donor kidney transplant, if applicable; date of death, if applicable).

Demographic data (e.g. age, sex, race, ethnicity), household size, and household income will be collected on all potential donors that come forward for participating recipients, ideally as soon as they are known to the participating transplant center, and no later than six months after baseline and one year after baseline, if applicable). Administrative and financial data will be required only from the subset of donors meeting all of the following criteria:

  • Donors whose recipients are randomized to the treatment arm; AND
  • Donors who will incur lost wages and wish to receive lost wage reimbursement

A randomized controlled trial is the gold standard for program evaluation, since it allows for a statistical comparison of otherwise similar patients, and determination of a causal relationship between the intervention and the measured outcome. By comparing the outcomes of the control and treatment arms, we can determine whether the availability of reimbursement of lost wages for living donors increases the likelihood that the potential recipient will receive a living donor kidney within a year of their initial evaluation visit to a participating transplant center. We will also conduct secondary analyses of the timing of transplants and the demographics of the living donors.

Study Type

Interventional

Enrollment (Actual)

1310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Kidney and Pancreas Transplant Program in collaboration with the Transplant Research and Education Center (TREC)
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Michigan Medicine - University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 at enrollment
  • Meet participating transplant center standards to initiate an evaluation to receive a kidney transplant
  • Kidney-only or kidney intended to be followed by other organ (e.g. deceased donor pancreas)
  • First-time recipient candidate
  • Capable of providing informed consent

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Kidney transplant recipient candidates who are informed that their living donor candidates can receive reimbursement for lost wages incurred during the evaluation, donation surgery and recuperation
Other: Information provision
Kidney transplant recipients are informed that their donors may be eligible for lost wage reimbursement
No Intervention: Control
Kidney transplant recipient candidates who receive standard of care (donors are not offered wage reimbursement)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of offering wage reimbursement on rate of living donor kidney transplant
Time Frame: One year from time zero
Number of kidney transplant recipient candidates in intervention vs. control group who receive a living door transplant within one year of their first visit to the participating transplant center for evaluation as a potential kidney transplant recipient (time zero)
One year from time zero

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in time to outcome events (living donor transplant, deceased donor transplant, removal from transplant waiting list, death) between control group and intervention arm
Time Frame: Time zero to one year
Compare the effect of the program on recipient outcomes
Time zero to one year
Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool
Time Frame: Time zero to one year
Compare demographic characteristics of donors in the control and intervention arms 's living kidney donor pool with national living kidney donor characteristics
Time zero to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbor Research Collaborative for Health

Collaborators

Laura and John Arnold Foundation
American Society of Transplant Surgeons

Investigators

  • Principal Investigator: Kimberly A. Gifford, MBA, American Society of Transplant Surgeons
  • Principal Investigator: Judd Kessler, PhD, Wharton School, University of Pennsylvania
  • Principal Investigator: Robert M. Merion, MD, FACS, Arbor Research Collaborative for Health
  • Principal Investigator: Amit K. Mathur, MD, Mayo Clinic
  • Principal Investigator: Akinlolu O. Ojo, MD, PhD, MBA, University of Arizona Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

June 17, 2020

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kidney Donor Lost Wages Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study was terminated prior to full enrollment so there are no data to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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