<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268850</url>
  </required_header>
  <id_info>
    <org_study_id>2017P000213</org_study_id>
    <nct_id>NCT03268850</nct_id>
  </id_info>
  <brief_title>Living Kidney Donor Lost Wages Trial</brief_title>
  <official_title>Living Donor Lost Wages Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effectiveness of offering reimbursement for living donor lost&#xD;
      wages on the rate of live donor kidney transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields&#xD;
      superior outcomes compared to dialysis and deceased donor kidney transplantation (KT).&#xD;
      However, the annual number of LDKTs has declined over the last decade, particularly among&#xD;
      minority and low-income patients. The investigators hypothesize, and have preliminary data to&#xD;
      support, that the financial impact on living donors (LDs) is a major contributor to the LDKT&#xD;
      decline and for persistent racial disparities in LDKT rates. Many LDs have substantial&#xD;
      non-reimbursed direct and indirect costs, most notably the loss of income or wages following&#xD;
      surgery. In this study, the investigators will: (1) evaluate the effectiveness of offering&#xD;
      reimbursement for LD lost wages on the LDKT rate; (2) examine whether offering reimbursement&#xD;
      for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study&#xD;
      outcomes differ significantly by maximum reimbursement amount for LD lost wages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 5, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of wage reimbursement on LDKT rate</measure>
    <time_frame>1 year</time_frame>
    <description>LDKT rate in KT candidates compared to historical matched control group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of wage reimbursement on racial disparities in LDKT</measure>
    <time_frame>1 year</time_frame>
    <description>LDKT rate among minorities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference between reimbursement arms</measure>
    <time_frame>1 year</time_frame>
    <description>LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">453</enrollment>
  <condition>Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>LW-A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LW-B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>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.</description>
    <arm_group_label>LW-A</arm_group_label>
    <arm_group_label>LW-B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wage Reimbursement A</intervention_name>
    <description>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.&#xD;
Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria.</description>
    <arm_group_label>LW-A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wage Reimbursement B</intervention_name>
    <description>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.&#xD;
Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria.</description>
    <arm_group_label>LW-B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For KT patients:&#xD;
&#xD;
          -  Chronic Kidney Disease (CKD) stage 4/5&#xD;
&#xD;
          -  Approved for kidney transplant (KT) listing or active on KT waiting list&#xD;
&#xD;
          -  For patients listed at multiple centers: primary listing at Beth Israel Deaconess&#xD;
             Medical Center (BIDMC)&#xD;
&#xD;
          -  For LDs:&#xD;
&#xD;
          -  Their KT candidate is enrolled in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For KT patients:&#xD;
&#xD;
          -  KT candidate has a potential LD approved, with surgery scheduled&#xD;
&#xD;
          -  Listed for multi-organ transplantation&#xD;
&#xD;
          -  Temporarily unavailable (TU) status on KT waiting list&#xD;
&#xD;
          -  Current enrollment in another study to increase LDKT likelihood&#xD;
&#xD;
          -  For LDs:&#xD;
&#xD;
          -  Not residing in the US&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>BIDMC Transplant Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>James Rodrigue</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>LDKT</keyword>
  <keyword>Live donor transplantation</keyword>
  <keyword>Kidney transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268850
org study id: 2017P000213
nct id: NCT03268850
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effectiveness of offering reimbursement for living donor lost
      wages on the rate of live donor kidney transplantation.
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.
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.
primary purpose: Other
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.
measure: Effectiveness of wage reimbursement on LDKT rate
time frame: 1 year
description: LDKT rate in KT candidates compared to historical matched control group
measure: Effect of wage reimbursement on racial disparities in LDKT
time frame: 1 year
description: LDKT rate among minorities
measure: Difference between reimbursement arms
time frame: 1 year
description: LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm
arm group label: LW-A
arm group type: Experimental
description: 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.
arm group label: LW-B
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Standard of Care
description: 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.
arm group label: LW-A
arm group label: LW-B
intervention type: Behavioral
intervention name: Wage Reimbursement A
description: 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.
arm group label: LW-A
intervention type: Behavioral
intervention name: Wage Reimbursement B
description: 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.
arm group label: LW-B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: James Rodrigue
investigator title: Primary Investigator
mesh term: Kidney Diseases
sharing ipd: No