Use of Financial Incentives to Increase Live Kidney Donor Follow-up Compliance

Background and Scientific Rationale:

Live kidney donors provide nearly 1/3 of the kidneys used for transplantation in the United
States each year. While the surgical procedure for live donation poses minimal immediate risk
to the donor, live donation has been associated with increased risk for development of
chronic disease including hypertension and kidney disease. A meta-analysis of 5,145 live
kidney donors demonstrated a larger increase in blood pressure than would be expected with
normal aging. Preliminary data from the investigators' research groups recently demonstrated
that the incidence of end-stage renal disease (ESRD) at fifteen years post donation was 30.8
per 10,000 donors compared to just 3.9 per 10,000 matched healthy non-donors. Utilization of
healthcare resources plays an important role in the mitigation of chronic disease, and has
the potential to effect development of chronic conditions in live donors. Kidney donors are a
unique population. They are otherwise healthy individuals who have lost half of their renal
mass and are at risk for long-term sequelae. As such, donors cannot be treated as healthy
adults, and require greater surveillance following donation.

There are over 5,500 new live kidney donors entering the organ transplant system each year,
but centers have had historically poor follow-up. The Organ Procurement and Transplantation
Network/United Network for Organ Sharing (OPTN/UNOS) has collected follow-up data on live
kidney donors, including serum creatinine, blood pressure, and body mass index at 6 months
and 1 year post donation since 1999. However, approximately half of live kidney donors had
incomplete 1 year follow-up data and one-third were lost to follow-up. Results from a
national survey in 2010 found that 40% of centers lost contact with more than 75% of donors
by 2 years post-donation. By 2011, national efforts were underway to improve live donor
follow-up, and in 2013, the OPTN implemented a national policy to improve follow-up by
requiring transplant centers to reach certain thresholds for collecting and recording data on
live kidney donors over time. Over the course of the last few years, compliance thresholds
have increased, and OPTN now requires that 80% of clinical data (presence of hypertension,
diabetes, dialysis, kidney related complications, recent hospitalizations, medical insurance
status, income, and vital status) and 70% of laboratory data (serum creatinine and urine
protein) are recorded and submitted for live kidney donors.

Financial incentivization has been employed in other realms of healthcare to change
health-related behaviors, encourage compliance with medications and to ultimately improve
health outcomes. Monetary rewards have been shown to be associated with higher rates of
abstinence from smoking at 6 months. However, other randomized clinical trials evaluating
efficacy of lottery-based incentives showed benefit in only subgroups of patients who were at
higher risk for poor adherence at baseline. While there is research demonstrating the
benefits of lottery-based incentive schemes vs direct monetary incentives in raising
participation among workers providing health risk assessments, the participation rates were
still quite low even in the best groups (64% vs 40%).

Rationale:

With historically poor follow-up and increased risk for development of chronic diseases
related to the loss of renal mass, live kidney donors are a vulnerable group in need of
intervention to prevent poor outcomes. As transplant centers strive for follow-up compliance
of 80%, new and creative incentives have a role in increasing compliance rates in this
population. However, given the uncertainty of the impact of monetary incentives in the
literature, the investigators believe it best to perform a randomized controlled trial of
incentivization for live kidney donation follow-up compliance prior to implementing a
center-wide action that would provide incentivization for every patient.

The investigators hypothesize that live kidney donors who receive small-amount gift cards
following completion of each follow-up requirement will have higher rates of follow-up than
those patients who are not incentivized.

Potential Risks and Benefits:

There is a risk that information about the participants could become known. However, this
risk is minimal, as all data gathered will be kept completely confidential to the best of the
ability of the research team. Participant names and other identifying information will be
known by the fewest number of personnel possible in order to carry out the study, and data
will be de-identified prior to analysis in order to limit risk of exposure of protected
health information.

There is no direct benefit from study participation, other than the small-amount incentives
themselves for those in the intervention arm.

Participation in the study would help providers, patients, and future live kidney donors by
contributing to the potential increase in follow-up for live kidney donors.

Objectives and Purpose:

The primary objective of this study is to compare the rate of follow-up compliance of live
kidney donors receiving small-amount gift card incentives to the rate of those who do not
receive an incentive. The investigators will compare rate of follow-up at 6 months, 1 year,
and 2 years between intervention and control arms.

The secondary objective is to evaluate the effectiveness of these small incentives on overall
compliance in the comprehensive transplant center, reaching the goal OPTN threshold of 80%
clinical and 70% laboratory compliance for living kidney donors.

The purpose of the trial is to evaluate the utility of small-amount gift cards in both
meeting national standards on a center-level, and to increase the provision of high-quality
follow-up care to live-kidney donors.

Inclusion Criteria:

- Adults (≥18 years)

- Have undergone live donor nephrectomy at the Johns Hopkins Hospital

Exclusion Criteria:

- International live kidney donors

- Non-English speaking live kidney donors