<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/NCT02202018</url>
  </required_header>
  <id_info>
    <org_study_id>REB13-0083_MOD1</org_study_id>
    <nct_id>NCT02202018</nct_id>
  </id_info>
  <brief_title>A Cluster Randomized Trial to Assess the Impact of Patient and Provider Education on Use of Home Dialysis</brief_title>
  <official_title>Patient and Provider Education for Patients With Severe Chronic Kidney Disease: Assessing the Impact on Barriers and Use of Home Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with severe kidney failure require dialysis or transplantation to survive. For those&#xD;
      in whom a transplant is not an option, there are two main dialysis options: hemodialysis&#xD;
      (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal&#xD;
      and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion&#xD;
      of home-based therapies varying between 10 and 40% across centres. Studies show that the low&#xD;
      use of home dialysis is due to a variety of factors, though patient and provider awareness&#xD;
      and knowledge of home dialysis are major factors. In this cluster randomized trial, the&#xD;
      investigators will determine whether a standardized modality education program directed at&#xD;
      patients, in combination with a provider-directed intervention, can increase the use of home&#xD;
      dialysis in incident dialysis patients in Canada.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Patients with severe kidney failure require dialysis or transplantation to&#xD;
      survive. For those in whom a transplant is not an option, there are two main dialysis&#xD;
      options: hemodialysis (either incenter or at home) or home peritoneal dialysis. Home-based&#xD;
      therapies (peritoneal and home hemodialysis) are under-utilized in many Canadian&#xD;
      jurisdictions with the proportion of home-based therapies varying between 10 and 40% across&#xD;
      centres. The use of home dialysis remains lower than expected due to combination of patient,&#xD;
      caregiver, provider, and health system barriers. Previous studies have highlighted several&#xD;
      potential patient and caregiver barriers to use of home therapies including knowledge,&#xD;
      skills, personal circumstances, and social supports. Provider barriers have been reported to&#xD;
      include lack of training in peritoneal dialysis, lack (or perceived lack) in skills and&#xD;
      knowledge, bias, and possibly inadequate physician reimbursement for home dialysis.&#xD;
&#xD;
      The Canadian Kidney Knowledge Translation and Generation Network (CANN-NET), a national&#xD;
      network of clinicians, researchers and knowledge users that was established to ensure best&#xD;
      practices for patients with chronic kidney disease (CKD), recently created dialysis modality&#xD;
      educational tools aimed at patients and kidney health care providers. On behalf of CANN-NET,&#xD;
      the investigators propose a cluster randomized controlled trial (with clusters consisting of&#xD;
      severe CKD clinics) of a knowledge translation (KT) strategy to increase use of home dialysis&#xD;
      in patients with end-stage renal disease. Informed by careful survey work, clinics randomized&#xD;
      to the knowledge translation intervention will receive patient and provider directed&#xD;
      educational tools, including the MATCH D tool, compelling visual aids (infographic, white&#xD;
      board animated video, and an educational video on dialysis modality options), audit and&#xD;
      feedback, and in-person medical detailing. Control clinics will continue with their usual&#xD;
      practice with respect to dialysis modality education.&#xD;
&#xD;
      Primary Objective To determine whether a standardized modality education program directed at&#xD;
      patients, in combination with provider-directed interventions can increase the use of home&#xD;
      dialysis in incident dialysis patients in Canada&#xD;
&#xD;
      Study Design: A cluster randomized trial of CKD clinics across Canada comparing the efficacy&#xD;
      and safety of a KT intervention aiming to increase use of home dialysis in patients with&#xD;
      advanced CKD. The unit of observation will be the patient (i.e., outcomes will be measured at&#xD;
      the level of an individual patient), and the unit of randomization will be at the level of&#xD;
      the multidisciplinary CKD clinic.&#xD;
&#xD;
      Team: The investigative study team includes experts in the clinical epidemiology of CKD and&#xD;
      kidney failure, local opinion leaders from every province/region, as well experts in&#xD;
      knowledge translation and cluster randomized design. As such, the investigators are well&#xD;
      positioned to carry out the proposed study.&#xD;
&#xD;
      Research Significance: Home dialysis, in comparison to incenter hemodialysis, is associated&#xD;
      with increased patient independence, better clinical outcomes, and lower health care costs.&#xD;
      Due to a variety of factors, home dialysis use remains variable across Canada. This study&#xD;
      will test the effectiveness of a KT strategy to increase the use of home dialysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Efficacy Outcome: Use of home dialysis</measure>
    <time_frame>Use of home dialysis at six months after dialysis initiation</time_frame>
    <description>Proportion of patients with incident end-stage renal disease initiating dialysis after the intervention who are using home dialysis (home hemodialysis or peritoneal dialysis) six months after dialysis initiation. Use of home dialysis will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcome: Use of home dialysis at six months in patients who have been followed by a Nephrologist</measure>
    <time_frame>Use of home dialysis at six months after dialysis initiation in patients who have been followed by a Nephrologist</time_frame>
    <description>Proportion of patients with incident end-stage renal disease initiating dialysis after the intervention who were followed by a Nephrologist prior to dialysis initiation who are using home dialysis (home hemodialysis or peritoneal dialysis) six months after dialysis initiation. Use of home dialysis will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Active KT Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CKD clinics receiving the active knowledge translation intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinics will continue their standard of care education and approach to use of home dialysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active KT intervention</intervention_name>
    <description>Provider &amp; patient-directed infographics educating patients about home dialysis will be displayed in prominent clinic wall space&#xD;
Educational white board presentations promoting home dialysis&#xD;
Each clinic will receive reports outlining their current use of home dialysis in incident ESRD patients compared with provincial &amp; national averages&#xD;
A Canadian version of the MATCH D tool will be provided to clinic staff, to help evaluate patient appropriateness for home dialysis.&#xD;
Each clinic will receive an in-person visit from one of the study investigators/collaborators detailing the benefits of home dialysis, and the educational tools being offered to support care within their clinic.</description>
    <arm_group_label>Active KT Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Multidisciplinary clinics in Canada that provide care coordinated by a Nephrologist to&#xD;
             patients with chronic kidney disease (CKD). These clinics have already been identified&#xD;
             in a previous survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Navdeep Tangri, MD PhD FRCPC</last_name>
    <role>Study Director</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Braden Manns, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3T 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Braden Manns</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Knowledge Translation</keyword>
  <keyword>Chronic Kidney Disease</keyword>
  <keyword>Dialysis</keyword>
  <keyword>Home dialysis</keyword>
  <keyword>Cluster randomized trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02202018
org study id: REB13-0083_MOD1
nct id: NCT02202018
lead sponsor: 
collaborator: 
has dmc: No
Patients with severe kidney failure require dialysis or transplantation to survive. For those
      in whom a transplant is not an option, there are two main dialysis options: hemodialysis
      (either incenter or at home) or home peritoneal dialysis. Home-based therapies (peritoneal
      and home hemodialysis) are under-utilized in many Canadian jurisdictions with the proportion
      of home-based therapies varying between 10 and 40% across centres. Studies show that the low
      use of home dialysis is due to a variety of factors, though patient and provider awareness
      and knowledge of home dialysis are major factors. In this cluster randomized trial, the
      investigators will determine whether a standardized modality education program directed at
      patients, in combination with a provider-directed intervention, can increase the use of home
      dialysis in incident dialysis patients in Canada.
Background: Patients with severe kidney failure require dialysis or transplantation to
      survive. For those in whom a transplant is not an option, there are two main dialysis
      options: hemodialysis (either incenter or at home) or home peritoneal dialysis. Home-based
      therapies (peritoneal and home hemodialysis) are under-utilized in many Canadian
      jurisdictions with the proportion of home-based therapies varying between 10 and 40% across
      centres. The use of home dialysis remains lower than expected due to combination of patient,
      caregiver, provider, and health system barriers. Previous studies have highlighted several
      potential patient and caregiver barriers to use of home therapies including knowledge,
      skills, personal circumstances, and social supports. Provider barriers have been reported to
      include lack of training in peritoneal dialysis, lack (or perceived lack) in skills and
      knowledge, bias, and possibly inadequate physician reimbursement for home dialysis.

      The Canadian Kidney Knowledge Translation and Generation Network (CANN-NET), a national
      network of clinicians, researchers and knowledge users that was established to ensure best
      practices for patients with chronic kidney disease (CKD), recently created dialysis modality
      educational tools aimed at patients and kidney health care providers. On behalf of CANN-NET,
      the investigators propose a cluster randomized controlled trial (with clusters consisting of
      severe CKD clinics) of a knowledge translation (KT) strategy to increase use of home dialysis
      in patients with end-stage renal disease. Informed by careful survey work, clinics randomized
      to the knowledge translation intervention will receive patient and provider directed
      educational tools, including the MATCH D tool, compelling visual aids (infographic, white
      board animated video, and an educational video on dialysis modality options), audit and
      feedback, and in-person medical detailing. Control clinics will continue with their usual
      practice with respect to dialysis modality education.

      Primary Objective To determine whether a standardized modality education program directed at
      patients, in combination with provider-directed interventions can increase the use of home
      dialysis in incident dialysis patients in Canada

      Study Design: A cluster randomized trial of CKD clinics across Canada comparing the efficacy
      and safety of a KT intervention aiming to increase use of home dialysis in patients with
      advanced CKD. The unit of observation will be the patient (i.e., outcomes will be measured at
      the level of an individual patient), and the unit of randomization will be at the level of
      the multidisciplinary CKD clinic.

      Team: The investigative study team includes experts in the clinical epidemiology of CKD and
      kidney failure, local opinion leaders from every province/region, as well experts in
      knowledge translation and cluster randomized design. As such, the investigators are well
      positioned to carry out the proposed study.

      Research Significance: Home dialysis, in comparison to incenter hemodialysis, is associated
      with increased patient independence, better clinical outcomes, and lower health care costs.
      Due to a variety of factors, home dialysis use remains variable across Canada. This study
      will test the effectiveness of a KT strategy to increase the use of home dialysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Primary Efficacy Outcome: Use of home dialysis
time frame: Use of home dialysis at six months after dialysis initiation
description: Proportion of patients with incident end-stage renal disease initiating dialysis after the intervention who are using home dialysis (home hemodialysis or peritoneal dialysis) six months after dialysis initiation. Use of home dialysis will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).
measure: Secondary outcome: Use of home dialysis at six months in patients who have been followed by a Nephrologist
time frame: Use of home dialysis at six months after dialysis initiation in patients who have been followed by a Nephrologist
description: Proportion of patients with incident end-stage renal disease initiating dialysis after the intervention who were followed by a Nephrologist prior to dialysis initiation who are using home dialysis (home hemodialysis or peritoneal dialysis) six months after dialysis initiation. Use of home dialysis will be ascertained from the clinic clusters and confirmed by linkage with the Canadian Organ Replacement Register (CORR).
arm group label: Active KT Intervention
arm group type: Experimental
description: CKD clinics receiving the active knowledge translation intervention.
arm group label: Usual standard of care
arm group type: No Intervention
description: Clinics will continue their standard of care education and approach to use of home dialysis.
intervention type: Other
intervention name: Active KT intervention
description: Provider & patient-directed infographics educating patients about home dialysis will be displayed in prominent clinic wall space
Educational white board presentations promoting home dialysis
Each clinic will receive reports outlining their current use of home dialysis in incident ESRD patients compared with provincial & national averages
A Canadian version of the MATCH D tool will be provided to clinic staff, to help evaluate patient appropriateness for home dialysis.
Each clinic will receive an in-person visit from one of the study investigators/collaborators detailing the benefits of home dialysis, and the educational tools being offered to support care within their clinic.
arm group label: Active KT Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Navdeep Tangri, MD PhD FRCPC
role: Study Director
affiliation: University of Manitoba
last name: Braden Manns, MD
role: Principal Investigator
affiliation: University of Calgary
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Braden Manns
investigator title: Professor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic