Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates
Status: | Recruiting |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/24/2019 |
Start Date: | November 15, 2017 |
End Date: | June 2020 |
Contact: | Christina Pustulka, BA |
Email: | christina.pustulka@arborresearch.org |
Phone: | 734-369-9642 |
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.
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.
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, 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.
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:
We found this trial at
6
sites
1150 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Principal Investigator: John C Magee, MD
Phone: 734-615-3822
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Timothy Pruett, MD
Phone: 612-626-2498
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Paige M Porrett, MD
Phone: 215-614-0528
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Denver, Colorado 80210
Principal Investigator: Trevor Nydam, MD
Phone: 720-848-0833
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Los Angeles, California 90024
Principal Investigator: Amy Waterman, PhD
Phone: 424-372-7088
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New York, New York 10029
Principal Investigator: Diane LaPointe-Rudow, DNP
Phone: 212-241-0255
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