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

NCT03090646 | Active Not Recruiting

• 1 other identifier: IRB00126158
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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).

Conditions

Living Donors; Nephrectomy; Kidney

Keywords

social behavioral; living donor kidney transplant; follow-up; health utilization; incentives

Outcome Measures

Primary Outcomes (1)

• 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 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 Outcomes (1)

• Hospital compliance with Reporting Requirements

  2 years

Other Outcomes (1)

• Logistical Challenges of Intervention Implementation

  2 years

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Financial Incentive

EXPERIMENTAL

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

Interventions

Financial Incentive OTHER

Up to three gift cards to a major online retailer.

Also known as: Behavioral

Financial Incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• International live kidney donors
• Non-English speaking live kidney donors

Sponsors & Collaborators

• Johns Hopkins University: lead
• The Living Legacy Foundation: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (2)

University of Maryland Medical Center Transplant Center

Baltimore, Maryland, 21201, United States

Location

The Johns Hopkins Hospital Comprehensive Transplant Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (12)

• 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.

  PMID: 16880460 BACKGROUND

• 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.

  PMID: 24519297 BACKGROUND

• 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.

  PMID: 25902877 BACKGROUND

• 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.

  PMID: 18853948 BACKGROUND

• 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.

  PMID: 20420647 BACKGROUND

• 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.

  PMID: 23388736 BACKGROUND

• 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.

  PMID: 22054039 BACKGROUND

• 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.

  PMID: 25970009 BACKGROUND

• 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.

  PMID: 22877814 BACKGROUND

• 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.

  PMID: 22208418 BACKGROUND

• Bisen SS, Ishaque T, Thomas AG, Waldram MM, Warren DS, Bannon J, Scalea JR, Segev DL, Garonzik-Wang JM, Massie AB, Levan ML. A Two-Center Randomized Controlled Trial to Assess Financial Incentives for Compliance With Living Kidney Donor Follow-Up in the United States. Clin Transplant. 2025 Dec;39(12):e70401. doi: 10.1111/ctr.70401.

  PMID: 41395879 DERIVED

• 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.

  PMID: 33167882 DERIVED

Study Officials

• Daniel Warren, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An analyst on the Johns Hopkins University (JHU) study team (blind to group allocations) will use Stata 15 multiprocessor (MP) for Linux (College Station, Texas, USA) to generate a list of sequential group assignments. This list will be used to create sequentially numbered, sealed, opaque envelopes that will be used to allocate participants to the control or intervention arms. Study personnel who create the sealed envelopes will not be involved in patient recruitment. Study personnel who conduct recruitment will not be permitted to view the list of sequential group assignment, and the envelopes will not be opened until after patients consent to participate. Therefore, group allocation will be concealed to both participants and recruiters until after study enrollment. The study is not blinded to providers, patients, or study personnel conducting data collection, but will be blinded to outcome assessors.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 27, 2017
• Study Start: March 22, 2017
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)