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

Not Applicable

Active, not recruiting

• Conditions: Kidney; Living Donors; Nephrectomy
• Interventions: Other: Financial Incentive

• Registration Number: NCT03090646
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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 post donation 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.

Study Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-20
• Study Start: 2017-03-22
• Study First Posted: 2017-03-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Financial Incentive	Financial Incentive	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.

Primary Outcome Measures

Name	Time	Method
Patient Compliance with Follow-Up	2 years	Rate of policy-defined complete (all components addressed) and timely (within 60 days before or after the 6-month, 1-year, or 2-year post donation 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).

Secondary Outcome Measures

Name	Time	Method
Hospital compliance with Reporting Requirements	2 years	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).

Trial Locations

Locations (2)

University of Maryland Medical Center Transplant Center; 🇺🇸 Baltimore, Maryland, United States

The Johns Hopkins Hospital Comprehensive Transplant Center; 🇺🇸 Baltimore, Maryland, United States