Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates

NCT03350269 | Terminated

• 1 other identifier: Kidney Donor Lost Wages Study
• Study Type: interventional
• Target: 1,310
• Locations: 1 country
• Sites: 6

Brief Summary

The study is designed as a randomized controlled trial. The investigators hypothesize that kidney transplant recipient candidates whose donors are offered reimbursement of lost wages (treatment arm) will have a higher probability of receiving a living donor kidney transplant than those randomized to no offer of lost wage reimbursement (control arm). The study expects to demonstrate incremental living donor kidney transplants by assisting individuals who wish to be living organ donors but would be otherwise unable to do so due to the obligatory forfeit of income during the evaluation, donation surgery, and post-operative recuperation periods.

Conditions

Kidney Failure; Surgery; Renal Failure

Keywords

Living kidney donation; Kidney transplant; Lost Wage Reimbursement

Outcome Measures

Primary Outcomes (1)

• Effect of offering wage reimbursement on rate of living donor kidney transplant

  Number of kidney transplant recipient candidates in intervention vs. control group who receive a living door transplant within one year of their first visit to the participating transplant center for evaluation as a potential kidney transplant recipient (time zero)

  One year from time zero

Secondary Outcomes (2)

• Difference in time to outcome events (living donor transplant, deceased donor transplant, removal from transplant waiting list, death) between control group and intervention arm

  Time zero to one year

• Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool

  Time zero to one year

Study Arms (2)

Intervention

EXPERIMENTAL

Kidney transplant recipient candidates who are informed that their living donor candidates can receive reimbursement for lost wages incurred during the evaluation, donation surgery and recuperation

Other: Information provision

Control

NO INTERVENTION

Kidney transplant recipient candidates who receive standard of care (donors are not offered wage reimbursement)

Interventions

Information provision OTHER

Kidney transplant recipients are informed that their donors may be eligible for lost wage reimbursement

Intervention

Eligibility Criteria

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

You may qualify if:

• Age ≥18 at enrollment
• Meet participating transplant center standards to initiate an evaluation to receive a kidney transplant
• Kidney-only or kidney intended to be followed by other organ (e.g. deceased donor pancreas)
• First-time recipient candidate
• Capable of providing informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• Arbor Research Collaborative for Health: lead
• Laura and John Arnold Foundation: collaborator
• American Society of Transplant Surgeons: collaborator

Study Sites (6)

UCLA Kidney and Pancreas Transplant Program in collaboration with the Transplant Research and Education Center (TREC)

Los Angeles, California, 90024, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (23)

• Agerskov H, Ludvigsen MS, Bistrup C, Pedersen BD. From donation to everyday life: Living kidney donors' experiences three months after donation. J Ren Care. 2016 Mar;42(1):43-52. doi: 10.1111/jorc.12137. Epub 2015 Oct 14.

  PMID: 26463844 BACKGROUND

• Larson DB, Jacobs C, Berglund D, Wiseman J, Garvey C, Gillingham K, Ibrahim HN, Matas AJ. Return to normal activities and work after living donor laparoscopic nephrectomy. Clin Transplant. 2017 Jan;31(1). doi: 10.1111/ctr.12862. Epub 2016 Dec 22.

  PMID: 27740731 BACKGROUND

• Clarke KS, Klarenbach S, Vlaicu S, Yang RC, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. The direct and indirect economic costs incurred by living kidney donors-a systematic review. Nephrol Dial Transplant. 2006 Jul;21(7):1952-60. doi: 10.1093/ndt/gfl069. Epub 2006 Mar 22.

  PMID: 16554329 BACKGROUND

• Waterman AD, Covelli T, Caisley L, Zerega W, Schnitzler M, Adams D, Hong BA. Potential living kidney donors' health education use and comfort with donation. Prog Transplant. 2004 Sep;14(3):233-40. doi: 10.1177/152692480401400309.

  PMID: 15495783 BACKGROUND

• Warren PH, Gifford KA, Hong BA, Merion RM, Ojo AO. Development of the National Living Donor Assistance Center: reducing financial disincentives to living organ donation. Prog Transplant. 2014 Mar;24(1):76-81. doi: 10.7182/pit2014593.

  PMID: 24598569 BACKGROUND

• Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group. Direct and Indirect Costs Following Living Kidney Donation: Findings From the KDOC Study. Am J Transplant. 2016 Mar;16(3):869-76. doi: 10.1111/ajt.13591. Epub 2016 Feb 4.

  PMID: 26845630 BACKGROUND

• Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group. Predonation Direct and Indirect Costs Incurred by Adults Who Donated a Kidney: Findings From the KDOC Study. Am J Transplant. 2015 Sep;15(9):2387-93. doi: 10.1111/ajt.13286. Epub 2015 May 5.

  PMID: 25943721 BACKGROUND

• Rodrigue JR, Schold JD, Mandelbrot DA. The decline in living kidney donation in the United States: random variation or cause for concern? Transplantation. 2013 Nov 15;96(9):767-73. doi: 10.1097/TP.0b013e318298fa61.

  PMID: 23759882 BACKGROUND

• Manyalich M, Ricart A, Martinez I, Balleste C, Paredes D, Vilardell J, Avsec D, Dias L, Fehrman-Eckholm I, Hiesse C, Kyriakides G, Line PD, Maxwell A, Nanni Costa A, Paez G, Turcu R, Walaszewski J. EULID project: European living donation and public health. Transplant Proc. 2009 Jul-Aug;41(6):2021-4. doi: 10.1016/j.transproceed.2009.05.021.

  PMID: 19715823 BACKGROUND

• Pruett TL, Tibell A, Alabdulkareem A, Bhandari M, Cronin DC, Dew MA, Dib-Kuri A, Gutmann T, Matas A, McMurdo L, Rahmel A, Rizvi SA, Wright L, Delmonico FL. The ethics statement of the Vancouver Forum on the live lung, liver, pancreas, and intestine donor. Transplantation. 2006 May 27;81(10):1386-7. doi: 10.1097/01.tp.0000214976.36526.e3. No abstract available.

  PMID: 16732173 BACKGROUND

• Collier R. Ontario and Manitoba to reimburse expenses for living organ donors. CMAJ. 2008 Jun 3;178(12):1535. doi: 10.1503/cmaj.080704. No abstract available.

  PMID: 18519896 BACKGROUND

• Concejero AM, Chen CL. Ethical perspectives on living donor organ transplantation in Asia. Liver Transpl. 2009 Dec;15(12):1658-61. doi: 10.1002/lt.21930.

  PMID: 19938130 BACKGROUND

• Hippen B, Matas A. Incentives for organ donation in the United States: feasible alternative or forthcoming apocalypse? Curr Opin Organ Transplant. 2009 Apr;14(2):140-6. doi: 10.1097/MOT.0b013e3283295e0d.

  PMID: 19307965 BACKGROUND

• Howell E, Corder L, Dobson A. Out-of-pocket health expenses for Medicaid and other poor and near-poor persons in 1980. Natl Med Care Util Expend Surv B. 1985 Aug;(4):1-52.

  PMID: 10313450 BACKGROUND

• Jotkowitz A. Notes on the new Israeli organ donation law-2008. Transplant Proc. 2008 Dec;40(10):3297-8. doi: 10.1016/j.transproceed.2008.08.128.

  PMID: 19100375 BACKGROUND

• Price D. Living kidney donation in Europe: legal and ethical perspectives--the EUROTOLD Project. Transpl Int. 1994;7 Suppl 1:S665-7. doi: 10.1111/j.1432-2277.1994.tb01468.x.

  PMID: 11271334 BACKGROUND

• Rithalia A, McDaid C, Suekarran S, Norman G, Myers L, Sowden A. A systematic review of presumed consent systems for deceased organ donation. Health Technol Assess. 2009 May;13(26):iii, ix-xi, 1-95. doi: 10.3310/hta13260.

  PMID: 19422754 BACKGROUND

• Rizvi AH, Naqvi AS, Zafar NM, Ahmed E. Regulated compensated donation in Pakistan and Iran. Curr Opin Organ Transplant. 2009 Apr;14(2):124-8. doi: 10.1097/mot.0b013e328326f6ef.

  PMID: 19469028 BACKGROUND

• Rodrigue JR, Crist K, Roberts JP, Freeman RB Jr, Merion RM, Reed AI. Stimulus for organ donation: a survey of the American Society of Transplant Surgeons membership. Am J Transplant. 2009 Sep;9(9):2172-6. doi: 10.1111/j.1600-6143.2009.02741.x. Epub 2009 Jul 16.

  PMID: 19624568 BACKGROUND

• Vlaicu S, Klarenbach S, Yang RC, Dempster T, Garg AX. Current Canadian initiatives to reimburse live organ donors for their non-medical expenses. Can J Public Health. 2007 Nov-Dec;98(6):481-3. doi: 10.1007/BF03405443.

  PMID: 19039887 BACKGROUND

• Sells R. Incentives for organ donation: some ethical issues. Ann Transplant. 2004;9(1):23-4.

  PMID: 15478883 BACKGROUND

• Schulz-Baldes A, Delmonico FL. Improving institutional fairness to live kidney donors: donor needs must be addressed by safeguarding donation risks and compensating donation costs. Transpl Int. 2007 Nov;20(11):940-6. doi: 10.1111/j.1432-2277.2007.00542.x. Epub 2007 Aug 17.

  PMID: 17711405 BACKGROUND

• Wolters HH, Heidenreich S, Senninger N. Living donor kidney transplantation: chance for the recipient--financial risk for the donor? Transplant Proc. 2003 Sep;35(6):2091-2. doi: 10.1016/s0041-1345(03)00675-4.

  PMID: 14529850 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kimberly A. Gifford, MBA

  American Society of Transplant Surgeons

  PRINCIPAL INVESTIGATOR

• Judd Kessler, PhD

  Wharton School, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Robert M. Merion, MD, FACS

  Arbor Research Collaborative for Health

  PRINCIPAL INVESTIGATOR

• Amit K. Mathur, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Akinlolu O. Ojo, MD, PhD, MBA

  University of Arizona Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 22, 2017
• Study Start: November 15, 2017
• Primary Completion: June 17, 2020
• Study Completion: October 20, 2020
• Last Updated: January 3, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)