- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03090646
Use of Financial Incentives to Increase Live Kidney Donor Follow-up Compliance
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center Transplant Center
-
Baltimore, Maryland, United States, 21287
- The Johns Hopkins Hospital Comprehensive Transplant Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
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
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.
|
Up to three gift cards to a major online retailer.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital compliance with Reporting Requirements
Time Frame: 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).
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Logistical Challenges of Intervention Implementation
Time Frame: 2 years
|
Data related to potential logistical challenges of implementing the intervention (e.g., number of mailing attempts necessary, failed delivery attempts, incorrect or out-of-date contact information, etc.).
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Warren, PhD, Johns Hopkins University
Publications and helpful links
General Publications
- Halpern SD, French B, Small DS, Saulsgiver K, Harhay MO, Audrain-McGovern J, Loewenstein G, Brennan TA, Asch DA, Volpp KG. Randomized trial of four financial-incentive programs for smoking cessation. N Engl J Med. 2015 May 28;372(22):2108-17. doi: 10.1056/NEJMoa1414293. Epub 2015 May 13.
- Boudville N, Prasad GV, Knoll G, Muirhead N, Thiessen-Philbrook H, Yang RC, Rosas-Arellano MP, Housawi A, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. Meta-analysis: risk for hypertension in living kidney donors. Ann Intern Med. 2006 Aug 1;145(3):185-96. doi: 10.7326/0003-4819-145-3-200608010-00006.
- Muzaale AD, Massie AB, Wang MC, Montgomery RA, McBride MA, Wainright JL, Segev DL. Risk of end-stage renal disease following live kidney donation. JAMA. 2014 Feb 12;311(6):579-86. doi: 10.1001/jama.2013.285141.
- Schold JD, Buccini LD, Rodrigue JR, Mandelbrot D, Goldfarb DA, Flechner SM, Kayler LK, Poggio ED. Critical Factors Associated With Missing Follow-Up Data for Living Kidney Donors in the United States. Am J Transplant. 2015 Sep;15(9):2394-403. doi: 10.1111/ajt.13282. Epub 2015 Apr 22.
- Brown RS Jr, Higgins R, Pruett TL. The evolution and direction of OPTN oversight of live organ donation and transplantation in the United States. Am J Transplant. 2009 Jan;9(1):31-4. doi: 10.1111/j.1600-6143.2008.02433.x. Epub 2008 Oct 6.
- Klein AS, Messersmith EE, Ratner LE, Kochik R, Baliga PK, Ojo AO. Organ donation and utilization in the United States, 1999-2008. Am J Transplant. 2010 Apr;10(4 Pt 2):973-86. doi: 10.1111/j.1600-6143.2009.03008.x.
- Waterman AD, Dew MA, Davis CL, McCabe M, Wainright JL, Forland CL, Bolton L, Cooper M. Living-donor follow-up attitudes and practices in U.S. kidney and liver donor programs. Transplantation. 2013 Mar 27;95(6):883-8. doi: 10.1097/TP.0b013e31828279fd.
- Living Kidney Donor Follow-Up Conference Writing Group; Leichtman A, Abecassis M, Barr M, Charlton M, Cohen D, Confer D, Cooper M, Danovitch G, Davis C, Delmonico F, Dew MA, Garvey C, Gaston R, Gill J, Gillespie B, Ibrahim H, Jacobs C, Kahn J, Kasiske B, Kim J, Lentine K, Manyalich M, Medina-Pestana J, Merion R, Moxey-Mims M, Odim J, Opelz G, Orlowski J, Rizvi A, Roberts J, Segev DL, Sledge T, Steiner R, Taler S, Textor S, Thiel G, Waterman A, Williams E, Wolfe R, Wynn J, Matas AJ. Living kidney donor follow-up: state-of-the-art and future directions, conference summary and recommendations. Am J Transplant. 2011 Dec;11(12):2561-8. doi: 10.1111/j.1600-6143.2011.03816.x. Epub 2011 Nov 4.
- Kimmel SE, Troxel AB, Loewenstein G, Brensinger CM, Jaskowiak J, Doshi JA, Laskin M, Volpp K. Randomized trial of lottery-based incentives to improve warfarin adherence. Am Heart J. 2012 Aug;164(2):268-74. doi: 10.1016/j.ahj.2012.05.005.
- Haisley E, Volpp KG, Pellathy T, Loewenstein G. The impact of alternative incentive schemes on completion of health risk assessments. Am J Health Promot. 2012 Jan-Feb;26(3):184-8. doi: 10.4278/ajhp.100729-ARB-257.
- Levan ML, Waldram MM, DiBrito SR, Thomas AG, Al Ammary F, Ottman S, Bannon J, Brennan DC, Massie AB, Scalea J, Barth RN, Segev DL, Garonzik-Wang JM. Financial incentives versus standard of care to improve patient compliance with live kidney donor follow-up: protocol for a multi-center, parallel-group randomized controlled trial. BMC Nephrol. 2020 Nov 9;21(1):465. doi: 10.1186/s12882-020-02117-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00126158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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