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

Study Overview
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Brief Summary
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This study evaluates whether using small financial incentives increases patient compliance with nationally-mandated living kidney donor follow-up at 6-months, 1-year, and 2-years after donation. Half of participants will receive a financial incentive (mailed gift card) after completing required follow-up activities (brief questionnaire and lab draw), while the other half will be asked to complete the required follow-up activities but will not receive a financial incentive (current standard of care).

Detailed Description
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Living kidney donors account for nearly a third of kidney transplants performed in the United States each year. While donor nephrectomy poses minimal post-surgical risk, donors face a small but measurable increase in the risk of developing kidney failure and other chronic diseases (including hypertension, chronic kidney disease, and diabetes) in the long-term. Routine screening presents an opportunity for the early detection and management of chronic conditions. Transplant hospital reporting requirements mandate the submission of laboratory and clinical data at 6-months, 1-year, and 2-years after kidney donation, but less than 50% of hospitals are able to comply. Transplant hospitals commonly cite barriers such as donor inconvenience, direct and indirect costs to donors, donors not wanting to return to the program, and the burden of data collection. Tools to improve donor engagement and strategies that mitigate patient and administrative burden are needed. Financial incentives have been employed in many realms of healthcare to change health-related behaviors. Financial incentives include a variety of rewards that have an economic value for the recipient, including cash payments, coupons, goods, and services, and have been shown to positively influence both simple (i.e. accomplished through a single action) and complex (i.e. accomplished repeatedly over a period of time, often involving sustained lifestyle modifications) health-related behaviors. However, prior work suggests that the effectiveness of financial incentives in achieving health behavior often varies based on the characteristics of the population and health behavior of interest and may decrease over time. Given that patient-level factors are commonly cited by transplant hospitals as barriers to compliance with federally-mandated donor follow-up thresholds, financial incentives might be a valuable tool to promote patient engagement in postdonation monitoring efforts. However, given the uncertainty in the literature, a randomized controlled trial is necessary to evaluate the effectiveness of using financial incentivization to promote patient compliance with follow-up care in this setting.

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

Conditions
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Kidney, Living Donors, Nephrectomy

Intervention / Treatment
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* Other: Financial Incentive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥18 years) Have undergone live donor nephrectomy at the Johns Hopkins Hospital Comprehensive Transplant Center (MDJH) or the University of Maryland Medical Center Transplant Center (MDUM). Exclusion Criteria: International live kidney donors Non-English speaking live kidney donors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, controlled, nonblinded, two-arm, superiority trial with a 1:1 allocation ratio. Participants allocated to the intervention arm will receive up to three gift cards to a major online retailer in the mail after completion of the required 6-month, 1-year, and 2-year follow-up activities. Participants will be followed for the federally-mandated 2-year follow-up period.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Participants in the control arm will be instructed to attend required follow-up as is standard of care, but will not receive a financial incentive. | |
| Experimental: Financial Incentive<br>Up to three gift cards to a major online retailer will be mailed to participants assigned to the intervention arm after complete (i.e. all components addressed) and timely (i.e. within the policy-defined follow-up period) submission of follow-up data at each 6-month, 1-year, and 2-year follow-up visit. | Other: Financial Incentive<br>* Up to three gift cards to a major online retailer.<br>* Other names: Behavioral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Compliance with Follow-Up | Rate of policy-defined complete (all components addressed) and timely (within 60 days before or after the 6-month, 1-year, or 2-year postdonation date; i.e. 120-day period) submission of data at 6-month, 1-year, and 2-year follow-up visits (assessed separately for each follow-up time point and as a composite outcome over the study period). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital compliance with Reporting Requirements | Transplant hospital-level compliance with the Organ Procurement and Transplantation Network (OPTN) reporting requirements (submission of clinical data for 80% and laboratory data for 75% of donors) at each visit (assessed separately for each follow-up time point and as a composite outcome over the study period). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social behavioral, living donor kidney transplant, follow-up, health utilization, incentives