Surgery Clinical Trial
Official title:
Randomized Controlled Trial to Evaluate the Effect of Lost Wage Reimbursement to Potential Kidney Donors On Living Donation Rates
Verified date | January 2020 |
Source | Arbor Research Collaborative for Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1310 |
Est. completion date | October 20, 2020 |
Est. primary completion date | June 17, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Michigan Medicine - University of Michigan | Ann Arbor | Michigan |
United States | University of Colorado | Denver | Colorado |
United States | UCLA Kidney and Pancreas Transplant Program in collaboration with the Transplant Research and Education Center (TREC) | Los Angeles | California |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Mt. Sinai Medical Center | New York | New York |
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Arbor Research Collaborative for Health | American Society of Transplant Surgeons, Laura and John Arnold Foundation |
United States,
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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. Epub 2006 Mar 22. Review. — View Citation
Collier R. Ontario and Manitoba to reimburse expenses for living organ donors. CMAJ. 2008 Jun 3;178(12):1535. doi: 10.1503/cmaj.080704. — View Citation
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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. Review. — View Citation
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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. — View Citation
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Difference in time to outcome events (living donor transplant, deceased donor transplant, removal from transplant waiting list, death) between control group and intervention arm | Compare the effect of the program on recipient outcomes | Time zero to one year | |
Secondary | Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool | Compare demographic characteristics of donors in the control and intervention arms 's living kidney donor pool with national living kidney donor characteristics | Time zero to one year |
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