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

Primary Purpose

Kidney Failure, Surgery, Renal Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Information provision
Sponsored by
Arbor Research Collaborative for Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Failure focused on measuring Living kidney donation, Kidney transplant, Lost Wage Reimbursement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Kidney and Pancreas Transplant Program in collaboration with the Transplant Research and Education Center (TREC)
  • University of Colorado
  • Michigan Medicine - University of Michigan
  • University of Minnesota
  • Mt. Sinai Medical Center
  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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

Full Information

First Posted
November 14, 2017
Last Updated
December 13, 2021
Sponsor
Arbor Research Collaborative for Health
Collaborators
Laura and John Arnold Foundation, American Society of Transplant Surgeons
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1. Study Identification

Unique Protocol Identification Number
NCT03350269
Brief Title
Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates
Official Title
Randomized Controlled Trial to Evaluate the Effect of Lost Wage Reimbursement to Potential Kidney Donors On Living Donation Rates
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated prior to full enrollment
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
June 17, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbor Research Collaborative for Health
Collaborators
Laura and John Arnold Foundation, American Society of Transplant Surgeons

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Following confirmation of eligibility and written informed consent to participate in the study, kidney recipient candidates will be randomized at the time of their evaluation appointment to the treatment arm (donor eligible for reimbursement of lost wages) or the control arm (donor not eligible for reimbursement of lost wages). Consented, randomized recipients will be followed for up to one year from the baseline visit, with no required in-person visits beyond baseline. Data will be collected at baseline, six months after baseline, and one year after baseline. Demographic data (e.g. age, sex, race, ethnicity) will be collected on all recipients during screening and eligibility assessment. At baseline only, we will collect recipient household size, household income, and limited clinical data (on dialysis or not; date of dialysis initiation (if on dialysis); on deceased donor waiting list or not; date of wait-listing if on waiting list). At six months after baseline (and at one year after baseline, if applicable), we will collect recipient outcome data (date of receipt of living donor or deceased donor kidney transplant, if applicable; date of death, if applicable). Demographic data (e.g. age, sex, race, ethnicity), household size, and household income will be collected on all potential donors that come forward for participating recipients, ideally as soon as they are known to the participating transplant center, and no later than six months after baseline and one year after baseline, if applicable). Administrative and financial data will be required only from the subset of donors meeting all of the following criteria: Donors whose recipients are randomized to the treatment arm; AND Donors who will incur lost wages and wish to receive lost wage reimbursement A randomized controlled trial is the gold standard for program evaluation, since it allows for a statistical comparison of otherwise similar patients, and determination of a causal relationship between the intervention and the measured outcome. By comparing the outcomes of the control and treatment arms, we can determine whether the availability of reimbursement of lost wages for living donors increases the likelihood that the potential recipient will receive a living donor kidney within a year of their initial evaluation visit to a participating transplant center. We will also conduct secondary analyses of the timing of transplants and the demographics of the living donors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Surgery, Renal Failure
Keywords
Living kidney donation, Kidney transplant, Lost Wage Reimbursement

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Kidney transplant recipient candidates who receive standard of care (donors are not offered wage reimbursement)
Intervention Type
Other
Intervention Name(s)
Information provision
Intervention Description
Kidney transplant recipients are informed that their donors may be eligible for lost wage reimbursement
Primary Outcome Measure Information:
Title
Effect of offering wage reimbursement on rate of living donor kidney transplant
Description
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)
Time Frame
One year from time zero
Secondary Outcome Measure Information:
Title
Difference in time to outcome events (living donor transplant, deceased donor transplant, removal from transplant waiting list, death) between control group and intervention arm
Description
Compare the effect of the program on recipient outcomes
Time Frame
Time zero to one year
Title
Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool
Description
Compare demographic characteristics of donors in the control and intervention arms 's living kidney donor pool with national living kidney donor characteristics
Time Frame
Time zero to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A. Gifford, MBA
Organizational Affiliation
American Society of Transplant Surgeons
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judd Kessler, PhD
Organizational Affiliation
Wharton School, University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert M. Merion, MD, FACS
Organizational Affiliation
Arbor Research Collaborative for Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amit K. Mathur, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Akinlolu O. Ojo, MD, PhD, MBA
Organizational Affiliation
University of Arizona Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Kidney and Pancreas Transplant Program in collaboration with the Transplant Research and Education Center (TREC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Michigan Medicine - University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study was terminated prior to full enrollment so there are no data to be shared
Citations:
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Citation
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Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates

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