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

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.