<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/NCT03276390</url>
  </required_header>
  <id_info>
    <org_study_id>1R01DK104876-01</org_study_id>
    <nct_id>NCT03276390</nct_id>
  </id_info>
  <brief_title>A Culturally Targeted Transplant Program</brief_title>
  <acronym>HKTP</acronym>
  <official_title>A Culturally Targeted Transplant Program to Increase Live Donation in Hispanics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor Health Care System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Methodist Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</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>
      Hispanic/Latino patients with end-stage renal disease are disproportionately less likely to&#xD;
      get a kidney transplant, and specifically, a living donor kidney transplant (LDKT), compared&#xD;
      to non-Hispanic whites. Accordingly, without LDKTs, Hispanics experience longer transplant&#xD;
      waiting times, shorter patient and graft survival, and worse quality of life. Cultural&#xD;
      beliefs and linguistic barriers contribute to the disparity in LDKTs. The objective of the&#xD;
      proposed study is to implement and evaluate Northwestern Medicine's® Hispanic Kidney&#xD;
      Transplant Program, a culturally-competent transplant center-based intervention, at two&#xD;
      transplant centers serving large Hispanic populations. The proposed study will provide&#xD;
      valuable knowledge about the potential to rapidly disseminate the HKTP as a novel approach to&#xD;
      increase Hispanic LDKTs nationally.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The shortage of organs for kidney transplantation for patients with end-stage renal disease&#xD;
      (ESRD) is magnified in Hispanics/Latin Americans. Hispanics have a disproportionately higher&#xD;
      prevalence of ESRD, yet receive fewer kidney transplants compared to non-Hispanic whites.&#xD;
      Living donor kidney transplant (LDKT) is the treatment of choice for ESRD as it confers&#xD;
      better patient and graft survival, shorter waiting time, and better quality of life than&#xD;
      deceased donor kidney transplantation. However, compared to their representation on the&#xD;
      waiting list, fewer Hispanics received a LDKT than non-Hispanic whites in 2013: 4% versus&#xD;
      10%. Barriers to LDKT for Hispanics include: lack of knowledge, cultural concerns, and&#xD;
      language barriers. The disparity will likely worsen without intervention as Hispanics are the&#xD;
      largest and fastest growing minority group in the US.&#xD;
&#xD;
      Few available culturally competent interventions have led to increased LDKT rates.&#xD;
      Interventions rarely address Hispanic cultural concerns, and there are no published models of&#xD;
      transplant center-based only programs. The Chicago Northwestern Medicine's® Hispanic Kidney&#xD;
      Transplant Program (HKTP), a culturally and linguistically competent program, has increased&#xD;
      Hispanic LDKTs. The mean annual ratio of Hispanic to non-Hispanic white LDKTs grew from 0.20&#xD;
      in 2001-2006 to 0.34 in 2008-2013, a 70% increase (p&lt;0.001).&#xD;
&#xD;
      The objective of this study is to implement and evaluate the HKTP, a culturally-competent&#xD;
      transplant center-based intervention, at two transplant centers serving large Hispanic&#xD;
      populations (Dallas, TX, and Los Angeles, CA), with Northwestern University serving as the&#xD;
      Study Coordinating Center. The pre-post HKTP intervention study will evaluate the effect of&#xD;
      the HKTP's key culturally sensitive components (outreach, communication, education) on&#xD;
      Hispanic LDKT rates, compared to matched controls. The specific aims are to:&#xD;
&#xD;
        1. Implement the HKTP at two transplant centers by conducting a needs assessment of&#xD;
           barriers and using a &quot;learning collaborative&quot; model to deliver HKTP protocols, scripts,&#xD;
           and materials.&#xD;
&#xD;
        2. Conduct a pre-post HKTP intervention evaluation with matched controls to assess if the&#xD;
           HKTP is associated with an increase in: a) the ratio of Hispanic to non-Hispanic white&#xD;
           LDKTs as a function of an absolute increase in Hispanic LDKTs, b) ESRD Hispanic patient&#xD;
           additions to the waiting list, c) Hispanic potential donors per potential recipient, and&#xD;
           d) Hispanic patients' satisfaction with care.&#xD;
&#xD;
        3. Formatively evaluate the fidelity and innovative adaptations to HKTP's outreach,&#xD;
           communication, and education at both study sites to identify effective components of the&#xD;
           HTKP, using mixed methods.&#xD;
&#xD;
      As an exploratory aim, a budget impact analysis will be conducted to construct a business&#xD;
      case for transplant centers and permit estimates of HKTP scalability. The proposed study will&#xD;
      provide valuable knowledge about the potential to rapidly disseminate the HKTP as a novel&#xD;
      approach to increase Hispanic LDKTs nationally, improve health outcomes for Hispanics, and&#xD;
      close the LDKT disparity gap.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two group comparison (intervention vs. control) and pre-post comparison (within each site).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ratio of Hispanic to non-Hispanic white LDKTs</measure>
    <time_frame>Post-intervention exposure up to 3.5 years</time_frame>
    <description>A center-level variable. This is a metric of disparity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Hispanic living kidney donors</measure>
    <time_frame>Post-intervention exposure up to 3.5 years</time_frame>
    <description>A center-level variable. Exposure to the HKTP is expected to increase the number of Hispanic living kidney donors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of Hispanic ESRD patients added to the waiting list</measure>
    <time_frame>Post-intervention exposure up to 3.5 years</time_frame>
    <description>A center-level variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of Hispanic potential donors per potential recipient</measure>
    <time_frame>Post-intervention exposure up to 3.5 years</time_frame>
    <description>A center-level variable.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>satisfaction with culturally competent care</measure>
    <time_frame>in year 1-2 and year 4.5</time_frame>
    <description>A center-level variable. The CAHPS survey questionnaire will be used. A mean level of satisfaction will be prospectively comparing routine care with culturally competent care.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11836</enrollment>
  <condition>ESRD</condition>
  <arm_group>
    <arm_group_label>Intervention study site</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exposure to the intervention, which is the Northwestern Medicine (TM) Hispanic Kidney Transplant Program, a culturally targeted program for Hispanic potential recipients for transplant evaluation that is implemented into the 2 study sites.&#xD;
The intervention study site will provide the intervention to its Hispanic patients.&#xD;
The intervention study will will also provide the routine care (control arm) to all other patients.&#xD;
For the purposes of this study, Hispanic potential recipients recruited into the study will be exposed to this intervention. Non-Hispanic Whites recruited into the study will not be exposed to this intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention study site</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Exposure to routine transplant evaluation at the two control sites.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hispanic Kidney Transplant Program (HKTP)</intervention_name>
    <description>The HKTP entails culturally targeted education in Spanish about transplantation, outreach to dialysis patients by bicultural health care providers.</description>
    <arm_group_label>Intervention study site</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hispanic or non-Hispanic white potential recipients initiating evaluation for a&#xD;
             transplant&#xD;
&#xD;
          -  age 18 or older&#xD;
&#xD;
          -  The above potential recipients' potential donors initiating evaluation for living&#xD;
             donation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisa J Gordon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan Carlos J Caicedo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Arizon</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gordon EJ, Lee J, Kang RH, Caicedo JC, Holl JL, Ladner DP, Shumate MD. A complex culturally targeted intervention to reduce Hispanic disparities in living kidney donor transplantation: an effectiveness-implementation hybrid study protocol. BMC Health Serv Res. 2018 May 16;18(1):368. doi: 10.1186/s12913-018-3151-5.</citation>
    <PMID>29769080</PMID>
  </reference>
  <results_reference>
    <citation>Wang A, Caicedo JC, McNatt G, Abecassis M, Gordon EJ. Financial Feasibility Analysis of a Culturally and Linguistically Competent Hispanic Kidney Transplant Program. Transplantation. 2021 Mar 1;105(3):628-636. doi: 10.1097/TP.0000000000003269.</citation>
    <PMID>32282660</PMID>
  </results_reference>
  <results_reference>
    <citation>Gordon EJ, Romo E, Amortegui D, Rodas A, Anderson N, Uriarte J, McNatt G, Caicedo JC, Ladner DP, Shumate M. Implementing culturally competent transplant care and implications for reducing health disparities: A prospective qualitative study. Health Expect. 2020 Dec;23(6):1450-1465. doi: 10.1111/hex.13124. Epub 2020 Oct 9.</citation>
    <PMID>33037746</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 30, 2022</last_update_submitted>
  <last_update_submitted_qc>September 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Elisa Gordon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>health disparities</keyword>
  <keyword>living donation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03276390
org study id: 1R01DK104876-01
nct id: NCT03276390
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hispanic/Latino patients with end-stage renal disease are disproportionately less likely to
      get a kidney transplant, and specifically, a living donor kidney transplant (LDKT), compared
      to non-Hispanic whites. Accordingly, without LDKTs, Hispanics experience longer transplant
      waiting times, shorter patient and graft survival, and worse quality of life. Cultural
      beliefs and linguistic barriers contribute to the disparity in LDKTs. The objective of the
      proposed study is to implement and evaluate Northwestern Medicine's® Hispanic Kidney
      Transplant Program, a culturally-competent transplant center-based intervention, at two
      transplant centers serving large Hispanic populations. The proposed study will provide
      valuable knowledge about the potential to rapidly disseminate the HKTP as a novel approach to
      increase Hispanic LDKTs nationally.
The shortage of organs for kidney transplantation for patients with end-stage renal disease
      (ESRD) is magnified in Hispanics/Latin Americans. Hispanics have a disproportionately higher
      prevalence of ESRD, yet receive fewer kidney transplants compared to non-Hispanic whites.
      Living donor kidney transplant (LDKT) is the treatment of choice for ESRD as it confers
      better patient and graft survival, shorter waiting time, and better quality of life than
      deceased donor kidney transplantation. However, compared to their representation on the
      waiting list, fewer Hispanics received a LDKT than non-Hispanic whites in 2013: 4% versus
      10%. Barriers to LDKT for Hispanics include: lack of knowledge, cultural concerns, and
      language barriers. The disparity will likely worsen without intervention as Hispanics are the
      largest and fastest growing minority group in the US.

      Few available culturally competent interventions have led to increased LDKT rates.
      Interventions rarely address Hispanic cultural concerns, and there are no published models of
      transplant center-based only programs. The Chicago Northwestern Medicine's® Hispanic Kidney
      Transplant Program (HKTP), a culturally and linguistically competent program, has increased
      Hispanic LDKTs. The mean annual ratio of Hispanic to non-Hispanic white LDKTs grew from 0.20
      in 2001-2006 to 0.34 in 2008-2013, a 70% increase (p<0.001).

      The objective of this study is to implement and evaluate the HKTP, a culturally-competent
      transplant center-based intervention, at two transplant centers serving large Hispanic
      populations (Dallas, TX, and Los Angeles, CA), with Northwestern University serving as the
      Study Coordinating Center. The pre-post HKTP intervention study will evaluate the effect of
      the HKTP's key culturally sensitive components (outreach, communication, education) on
      Hispanic LDKT rates, compared to matched controls. The specific aims are to:

        1. Implement the HKTP at two transplant centers by conducting a needs assessment of
           barriers and using a "learning collaborative" model to deliver HKTP protocols, scripts,
           and materials.

        2. Conduct a pre-post HKTP intervention evaluation with matched controls to assess if the
           HKTP is associated with an increase in: a) the ratio of Hispanic to non-Hispanic white
           LDKTs as a function of an absolute increase in Hispanic LDKTs, b) ESRD Hispanic patient
           additions to the waiting list, c) Hispanic potential donors per potential recipient, and
           d) Hispanic patients' satisfaction with care.

        3. Formatively evaluate the fidelity and innovative adaptations to HKTP's outreach,
           communication, and education at both study sites to identify effective components of the
           HTKP, using mixed methods.

      As an exploratory aim, a budget impact analysis will be conducted to construct a business
      case for transplant centers and permit estimates of HKTP scalability. The proposed study will
      provide valuable knowledge about the potential to rapidly disseminate the HKTP as a novel
      approach to increase Hispanic LDKTs nationally, improve health outcomes for Hispanics, and
      close the LDKT disparity gap.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two group comparison (intervention vs. control) and pre-post comparison (within each site).
primary purpose: Health Services Research
masking: None (Open Label)
measure: Ratio of Hispanic to non-Hispanic white LDKTs
time frame: Post-intervention exposure up to 3.5 years
description: A center-level variable. This is a metric of disparity
measure: Number of Hispanic living kidney donors
time frame: Post-intervention exposure up to 3.5 years
description: A center-level variable. Exposure to the HKTP is expected to increase the number of Hispanic living kidney donors
measure: number of Hispanic ESRD patients added to the waiting list
time frame: Post-intervention exposure up to 3.5 years
description: A center-level variable.
measure: number of Hispanic potential donors per potential recipient
time frame: Post-intervention exposure up to 3.5 years
description: A center-level variable.
measure: satisfaction with culturally competent care
time frame: in year 1-2 and year 4.5
description: A center-level variable. The CAHPS survey questionnaire will be used. A mean level of satisfaction will be prospectively comparing routine care with culturally competent care.
arm group label: Intervention study site
arm group type: Active Comparator
description: Exposure to the intervention, which is the Northwestern Medicine (TM) Hispanic Kidney Transplant Program, a culturally targeted program for Hispanic potential recipients for transplant evaluation that is implemented into the 2 study sites.
The intervention study site will provide the intervention to its Hispanic patients.
The intervention study will will also provide the routine care (control arm) to all other patients.
For the purposes of this study, Hispanic potential recipients recruited into the study will be exposed to this intervention. Non-Hispanic Whites recruited into the study will not be exposed to this intervention.
arm group label: No intervention study site
arm group type: No Intervention
description: Exposure to routine transplant evaluation at the two control sites.
intervention type: Behavioral
intervention name: Hispanic Kidney Transplant Program (HKTP)
description: The HKTP entails culturally targeted education in Spanish about transplantation, outreach to dialysis patients by bicultural health care providers.
arm group label: Intervention study site
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Elisa J Gordon, PhD
role: Principal Investigator
affiliation: Northwestern University
last name: Juan Carlos J Caicedo, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Gordon EJ, Lee J, Kang RH, Caicedo JC, Holl JL, Ladner DP, Shumate MD. A complex culturally targeted intervention to reduce Hispanic disparities in living kidney donor transplantation: an effectiveness-implementation hybrid study protocol. BMC Health Serv Res. 2018 May 16;18(1):368. doi: 10.1186/s12913-018-3151-5.
PMID: 29769080
citation: Wang A, Caicedo JC, McNatt G, Abecassis M, Gordon EJ. Financial Feasibility Analysis of a Culturally and Linguistically Competent Hispanic Kidney Transplant Program. Transplantation. 2021 Mar 1;105(3):628-636. doi: 10.1097/TP.0000000000003269.
PMID: 32282660
citation: Gordon EJ, Romo E, Amortegui D, Rodas A, Anderson N, Uriarte J, McNatt G, Caicedo JC, Ladner DP, Shumate M. Implementing culturally competent transplant care and implications for reducing health disparities: A prospective qualitative study. Health Expect. 2020 Dec;23(6):1450-1465. doi: 10.1111/hex.13124. Epub 2020 Oct 9.
PMID: 33037746
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Elisa Gordon
investigator title: Professor
sharing ipd: Undecided