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Trial record 24 of 407 for:    Recruiting, Not yet recruiting, Available Studies | "Tissue Donors"

Living Kidney Donor Lost Wages Trial

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ClinicalTrials.gov Identifier: NCT03268850
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Other: Standard of Care Behavioral: Wage Reimbursement A Behavioral: Wage Reimbursement B Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 735 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Care Provider, 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.
Primary Purpose: Other
Official Title: Living Donor Lost Wages Trial
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: LW-A
The Lost Wages A (LW-A) arm will be composed of kidney transplant patients meeting the inclusion criteria. This arm allows for possible wage reimbursement of living donor lost wages up to a certain amount. This will also include standard of care.
Other: Standard 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.

Behavioral: Wage 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.


Experimental: LW-B
The Lost Wages B (LW-B) arm will be composed of kidney transplant patients meeting the inclusion criteria. This arm allows for possible wage reimbursement of living donor lost wages up to a different amount. This will also include standard of care.
Other: Standard 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.

Behavioral: Wage 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.





Primary Outcome Measures :
  1. Effectiveness of wage reimbursement on LDKT rate [ Time Frame: 1 year ]
    LDKT rate in KT candidates compared to historical matched control group

  2. Effect of wage reimbursement on racial disparities in LDKT [ Time Frame: 1 year ]
    LDKT rate among minorities

  3. Difference between reimbursement arms [ Time Frame: 1 year ]
    LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268850


Contacts
Contact: James R Rodrigue, PhD 6176329821 jrrodrig@bidmc.harvard.edu
Contact: Michaela S Carroll, BA 6176327041 mcarrol4@bidmc.harvard.edu

Locations
United States, Massachusetts
BIDMC Transplant Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: James R Rodrigue, PhD    617-632-9821    jrrodrig@bidmc.harvard.edu   
Contact: Michaela S Carroll, BA    6176327041 ext Rodrigue    mcarrol4@bidmc.harvard.edu   
Principal Investigator: James R. Rodrigue, PhD         
Sub-Investigator: Martha M Pavlakis, MD         
Sub-Investigator: Amy Evenson, MD, MPH         
Sub-Investigator: Aaron Fleishman, MPH         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center

Responsible Party: James Rodrigue, Primary Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03268850     History of Changes
Other Study ID Numbers: 2017P000213
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Rodrigue, Beth Israel Deaconess Medical Center:
LDKT
Live donor transplantation
Kidney transplantation

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases