Kidney Diseases
Conditions
Keywords
LDKT, Live donor transplantation, Kidney transplantation
Brief summary
This study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation.
Detailed description
Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor kidney transplantation (KT). However, the annual number of LDKTs has declined over the last decade, particularly among minority and low-income patients. The investigators 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, the investigators 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.
Interventions
OTHERStandard of Care
All patients participating in the study will continue to receive usual care. Kidney transplant (KT) candidates are advised that live donor kidney transplantation (LDKT) is their best treatment option and are encouraged to initiate living donor (LD) discussions with family members and friends.
BEHAVIORALWage Reimbursement A
Enrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount, based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages. Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria.
BEHAVIORALWage Reimbursement B
Enrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount (different from LW-A), based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages. Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Allocation will be concealed from the study investigators; however, research assistants conducting the assessments will not be blinded since the assessment protocol differs based on group assignment. Study participants will know which arm they are in, but not the reimbursement amount of the other arm.
Intervention model description
Candidates will be randomized 1:1 to the LW-A or LW-B arm, with stratification for race. The investigators will prepare the randomization schedule using permuted blocks of randomly varying size to limit predictability and imbalances in arm assignment throughout the study. KT candidates will be informed of group assignment immediately after consenting to the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For KT patients: * Chronic Kidney Disease (CKD) stage 4/5 * Approved for kidney transplant (KT) listing or active on KT waiting list * For patients listed at multiple centers: primary listing at Beth Israel Deaconess Medical Center (BIDMC) * For LDs: * Their KT candidate is enrolled in the trial
Exclusion criteria
* For KT patients: * KT candidate has a potential LD approved, with surgery scheduled * Listed for multi-organ transplantation * Temporarily unavailable (TU) status on KT waiting list * Current enrollment in another study to increase LDKT likelihood * For LDs: * Not residing in the US
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of wage reimbursement on LDKT rate | 1 year | LDKT rate in KT candidates compared to historical matched control group |
| Effect of wage reimbursement on racial disparities in LDKT | 1 year | LDKT rate among minorities |
| Difference between reimbursement arms | 1 year | LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm |
Countries
United States
Outcome results
None listed