Skip to main content
Clinical Trials/NCT03350269
NCT03350269
Terminated
Not Applicable

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

Arbor Research Collaborative for Health6 sites in 1 country1,310 target enrollmentNovember 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Failure
Sponsor
Arbor Research Collaborative for Health
Enrollment
1310
Locations
6
Primary Endpoint
Effect of offering wage reimbursement on rate of living donor kidney transplant
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2017
End Date
October 20, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • 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 zero to one year)
  • Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool(Time zero to one year)

Study Sites (6)

Loading locations...

Similar Trials