The waiting list for kidney transplantation (KT) now exceeds 100,000 and waiting times exceed 7 yrs in some U.S. regions. Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor KT. However, the annual number of LDKTs has declined over the last decade, particularly among minority and low-income patients. We hypothesize, and have preliminary data to support, that the financial impact on living donors (LDs) is a major contributor to the LDKT decline and for persistent racial disparities in LDKT rates. Many LDs have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. In this study, we will: (1) evaluate the effectiveness of offering reimbursement for LD lost wages on the LDKT rate; (2) examine whether offering reimbursement for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages. To accomplish these aims, we will conduct a blended randomized trial and matched historical control study with a planned enrollment of 350 KT candidates who will be randomized to one of two parallel arms: (1) possible reimbursement of LD lost wages up to $1,500 (LW-1.5), or (2) possible reimbursement of LD lost wages up to $3,000 (LW-3.0). Our central hypotheses are that offering reimbursement for LD lost wages will (a) yield higher LDKT rates overall relative to matched historical controls, and (b) reduce the disparity between LDKT rates in white and minority patients relative to historical patterns. Also, we hypothesize that KT candidates who are offered up to $3,000 reimbursement for LD lost wages will have a higher likelihood of LDKT compared to those offered up to $1,500 of reimbursement for LD lost wages. Finally, we will assess the impact of offering reimbursement for LD lost wages on the decision-making of both KT candidates and potential LDs as well as perceptions of pressure/coercion and decision stability. Overall, the proposed study will be the first to empirically examine the impact of offering LD lost wages reimbursement on the willingness of KT candidates to pursue LDKT, racial disparity in LDKT, rates of LD evaluations, and actual LDKT rates. Moreover, this study will be the first to examine the differential impact on these outcomes of offering to reimburse LD lost wages for different amounts ($1,500 vs. $3,000) after donation. As such, findings from this study have very high potential to impact policy, clinical practice, LDKT access, and known income and racial disparities in KT. The assembled interdisciplinary research team has a long track record of collaboration and is internationally recognized for developing innovative strategies to increase LDKT access in disadvantaged patient populations, extramural funding to conduct large RCTs and multi-center studies, and dissemination of research findings with broad policy and clinical practice implications.
This application is responsive to numerous calls within the transplant field to empirically evaluate the benefits and costs associated with removing financial disincentives for living kidney donors. If successful, findings from this study will directly address several HealthyPeople2020 objectives (Objectives: CKD HP2020-2, CKD HP2020-5, CKD HP2020-6, CKD HP2020-13), recommendations made in the Institute of Medicine?s (IOM) report on organ donation, and recommendations of the U.S. Department of Health and Human Services? Advisory Committee on Organ Transplantation. Findings from this study have very high potential to influence policy, clinical practice, LDKT access, and known income and racial disparities in kidney transplantation.
| Rodrigue, James R; Fleishman, Aaron; Carroll, Michaela et al. (2018) The Living Donor Lost Wages Trial: Study Rationale and Protocol. Curr Transplant Rep 5:45-54 |
