Clinical trial NCT03350269: Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates
Official title: Randomized Controlled Trial to Evaluate the Effect of Lost Wage Reimbursement to Potential Kidney Donors On Living Donation Rates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Kidney Failure
Surgery
Renal Failure
Keywords: Living kidney donation
Kidney transplant
Lost Wage Reimbursement
Lead sponsor: Arbor Research Collaborative for Health
Sponsor class: OTHER
Collaborators: name: Laura and John Arnold Foundation
name: American Society of Transplant Surgeons
First posted: 2017-11-22
Enrollment: 1310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

* None

Primary outcomes:
measure: Effect of offering wage reimbursement on rate of living donor kidney transplant
timeFrame: One year from time zero
Secondary outcomes:
measure: Difference in time to outcome events (living donor transplant, deceased donor transplant, removal from transplant waiting list, death) between control group and intervention arm
timeFrame: Time zero to one year
measure: Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool
timeFrame: Time zero to one year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Kidney and Pancreas Transplant Program in collaboration with the Transplant Research and Education Center (TREC)
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Ann Arbor
country: United States
facility: Michigan Medicine - University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: American Society of Transplant Surgeons
name: Kimberly A. Gifford, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Wharton School, University of Pennsylvania
name: Judd Kessler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arbor Research Collaborative for Health
name: Robert M. Merion, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Amit K. Mathur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona Health Sciences
name: Akinlolu O. Ojo, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
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