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Clinical Trials/NCT03090646
NCT03090646
Active, not recruiting
Not Applicable

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

Johns Hopkins University2 sites in 1 country320 target enrollmentMarch 22, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Living Donors
Sponsor
Johns Hopkins University
Enrollment
320
Locations
2
Primary Endpoint
Patient Compliance with Follow-Up
Status
Active, not recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 22, 2017
End Date
August 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patient Compliance with Follow-Up

Time Frame: 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 Outcomes

  • Hospital compliance with Reporting Requirements(2 years)

Study Sites (2)

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