Use of Financial Incentives to Increase Live Kidney Donor Follow-up Compliance
NCT ID: NCT03090646
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
320 participants
INTERVENTIONAL
2017-03-22
2026-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
The study is not blinded to providers, patients, or study personnel conducting data collection, but will be blinded to outcome assessors.
Study Groups
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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.
No interventions assigned to this group
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.
Financial Incentive
Up to three gift cards to a major online retailer.
Interventions
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Financial Incentive
Up to three gift cards to a major online retailer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Non-English speaking live kidney donors
18 Years
ALL
No
Sponsors
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The Living Legacy Foundation
UNKNOWN
University of Maryland, Baltimore
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Daniel Warren, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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University of Maryland Medical Center Transplant Center
Baltimore, Maryland, United States
The Johns Hopkins Hospital Comprehensive Transplant Center
Baltimore, Maryland, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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IRB00126158
Identifier Type: -
Identifier Source: org_study_id
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