<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/NCT03012256</url>
  </required_header>
  <id_info>
    <org_study_id>294080</org_study_id>
    <nct_id>NCT03012256</nct_id>
  </id_info>
  <brief_title>The DIVERT-CARE (Collaboration Action Research &amp; Evaluation) Trial</brief_title>
  <acronym>DIVERT-CARE</acronym>
  <official_title>The DIVERT-CARE (Collaboration Action Research &amp; Evaluation) Trial: A Multi Provincial Pragmatic Cluster Randomized Trial of Cardio-Respiratory Management in Home Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Frailty Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hamilton Niagara Haldimand Brant Local Health Integration Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Western Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vancouver Island Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster 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>
      Rationale:&#xD;
&#xD;
      In Canada, home care clients are a large and expanding subgroup of medically complex older&#xD;
      adults with relatively poor access to effective chronic disease management. They have double&#xD;
      the emergency department utilization rate compared to nursing home residents or other older&#xD;
      populations. The investigators previously published a case-finding tool (the Detection of&#xD;
      Indicators and Vulnerabilities for Emergency Room Trips (DIVERT) Scale) that has been&#xD;
      recommended for chronic disease management case-finding in home care. The investigators&#xD;
      recently conducted a pilot trial in Niagara, Canada, of a targeted, person-centered model of&#xD;
      supportive cardio-respiratory disease management.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The investigators will evaluate a cardio-respiratory disease management model in home care to&#xD;
      manage symptoms and avoid emergency department use. A pan-Canadian, pragmatic&#xD;
      cluster-randomized trial will be conducted by a collaboration of trial investigators and&#xD;
      public home care providers (i.e., health regions).&#xD;
&#xD;
      The main objective is to evaluate the effectiveness and preliminary cost-effectiveness of a&#xD;
      targeted, person-centered cardio-respiratory management model.&#xD;
&#xD;
      The main question is:&#xD;
&#xD;
      P: Among home care clients experiencing cardio-respiratory symptoms (objectively targeted&#xD;
      using the DIVERT Scale), I: can a guideline-based, feasible, multi-component/complex,&#xD;
      cardio-respiratory management model, C: compared to regular care, O: reduce&#xD;
      cardio-respiratory symptoms, reduce/postpone unplanned emergency department (ED) visits,&#xD;
      reduce unplanned hospital use, improve patient activation, or improve health-related quality&#xD;
      of life for clients, T: over a 6-month follow-up period from baseline?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND&#xD;
&#xD;
      Context:&#xD;
&#xD;
      Public home care services are delivered to at least 6% of Canadians age 65-74, 15% age 75-84&#xD;
      and 32% age 85 or older. These clients are medically complex, access care across settings,&#xD;
      have very high emergency department utilization rates, and have relatively poor access to&#xD;
      effective chronic disease management. Their frequent emergency department use is not aligned&#xD;
      with chronic disease management or geriatric care principles.&#xD;
&#xD;
      Effective chronic disease management models employ multiple components delivered by a&#xD;
      coordinated multidisciplinary team. According to the 'chronic disease management model', home&#xD;
      care plays a complementary function to medical practitioners. Clinical and self-care support&#xD;
      as well as case management are among the most effective components in chronic disease&#xD;
      management. Self-care education and support has been shown to improve health outcomes across&#xD;
      chronic diseases. Sustained follow-up by nurses or other non-medical staff is also effective.&#xD;
&#xD;
      Canadian home care providers, historically focused on the delivery of personal support&#xD;
      services, have started to develop supportive chronic disease management capacity (e.g.&#xD;
      specialist nurse monitoring). However, most trials exclude frail seniors and are not specific&#xD;
      to home care, which leaves little evidence to inform chronic disease management practices.&#xD;
&#xD;
      Previous Work:&#xD;
&#xD;
      Effective chronic disease management in home care has been limited by insufficient targeting&#xD;
      of clients at most need or most likely to benefit. The investigators developed and validated&#xD;
      a prognostic case-finding tool for home care known as the Detection of Indicators and&#xD;
      Vulnerabilities of Emergency Room Trips (DIVERT) Scale that has been recommended for home&#xD;
      care. It can be derived in real time from the Resident Assessment Instrument-Home Care&#xD;
      (RAI-HC) standardized home care assessment used in 9 Canadian provinces as well as Estonia,&#xD;
      Finland, Hong Kong, Iceland, Ireland, Italy, Japan, the Netherlands, New Zealand, Singapore,&#xD;
      Spain, Switzerland, and some U.S. states. Cardio-respiratory symptoms and conditions are&#xD;
      prominent predictive elements of the DIVERT Scale.&#xD;
&#xD;
      Based on evidence-based guidelines developed - in part - by the investigator team, the&#xD;
      investigators piloted the combined use of the DIVERT Scale with a multi-component&#xD;
      cardio-respiratory management model. The pilot pragmatic cluster randomized trial included&#xD;
      over 200 clients across six home care caseloads. The pilot was recognized on the 2015 Ontario&#xD;
      Minister's Medal Honour Role for Excellence in Health Quality.&#xD;
&#xD;
      OBJECTIVES The main objective is to evaluate the effectiveness and preliminary&#xD;
      cost-effectiveness of a targeted, person-centered cardio-respiratory management model.&#xD;
&#xD;
      Research questions:&#xD;
&#xD;
        1. Among home care clients experiencing cardio-respiratory symptoms (objectively targeted&#xD;
           using the DIVERT Scale), can a guideline-based, feasible, multi-component/complex,&#xD;
           cardio-respiratory management model, compared to regular care, reduce/postpone unplanned&#xD;
           emergency department (ED) visits, improve patient activation, reduce cardio-respiratory&#xD;
           symptoms, reduce unplanned hospital use, or improve health-related quality of life for&#xD;
           clients, over a 6-month follow-up period from baseline?&#xD;
&#xD;
        2. If effective, is there evidence for cost-effectiveness?&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      From evidence-based guidelines developed - in part - by this team, extensive client&#xD;
      profiling, and input of clients/families as well as health professionals, the investigators&#xD;
      developed a person-centred, multi-component cardio-respiratory management model containing&#xD;
      the following components: scheduled nurse-led self-management support (based on a training&#xD;
      program, and tool-kit), advanced care and goal planning, clinical pharmacist medication&#xD;
      reconciliation, team case rounds, SBAR (the Situation, Background, Assessment and&#xD;
      Recommendation) communication protocol with primary care, and a standardized transition&#xD;
      package. Each component has a specific objective within the model, however the manner in&#xD;
      which it is delivered may be adapted. The approach is based on evidence of effective&#xD;
      implementations in other fields, and includes all elements for 'person-centred care'.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The investigators will conduct a pragmatic, cluster-randomized trial that leverages secondary&#xD;
      electronic patient records. Sixty-six (66) geographic areas (home care caseloads) will be&#xD;
      randomized using a 1:2 (intervention: control) ratio.&#xD;
&#xD;
      Population:&#xD;
&#xD;
      Approximately 1,080 long-stay home care clients living in a non-institutional setting from 66&#xD;
      distinct geographic home care caseloads in Canada. Inclusion criteria: clients who are in the&#xD;
      DIVERT Scale target groups (9,10, 14, 15) will be included (i.e. at least one&#xD;
      cardio-respiratory symptom (chest pain, dyspnea, dizziness, irregular pulse) and at least one&#xD;
      cardiac condition (congestive heart failure or coronary artery disease)). The investigators&#xD;
      will utilize the DIVERT Scale as an objective measure of eligibility. Clients who are&#xD;
      receiving palliative care (i.e., prognosis of less than six months to live, K8e from Resident&#xD;
      Assessment Instrument-Home Care (RAI-HC)) or dialysis (P2g from RAI-HC) at baseline&#xD;
      assessment will be excluded.&#xD;
&#xD;
      Recruitment:&#xD;
&#xD;
      Eligible clients will be identified by each case manager during regular home care enrollment&#xD;
      and reassessment using the RAI-HC assessment (standard practice) for between 6 to 8 months.&#xD;
      Eligible clients will be automatically included into the intervention or 'regular care'&#xD;
      control on an intent-to-treat basis. Each home care provider's process for attaining consent&#xD;
      to intervention will apply. Study informed consent will not be sought given that the&#xD;
      cardio-respiratory management model is considered best practice care and is offered - whole&#xD;
      or in part - at the full clinical discretion of the home care provider as per existing&#xD;
      practice. The cardio-respiratory management is accepted - whole or in part - at the full&#xD;
      clinical discretion of the clients as per existing practice. Trial investigators have no part&#xD;
      in the intervention pilot data collection, individual care decision-making, or records&#xD;
      management during the study period beyond providing guidance and access to resources. All&#xD;
      trial data will be extracted from secondary data and anonymized prior to transmission by home&#xD;
      care provider staff.&#xD;
&#xD;
      Outcomes and Follow-up:&#xD;
&#xD;
      Primary Outcomes:&#xD;
&#xD;
        -  Difference in days to first unplanned emergency department visit within 6 months of&#xD;
           baseline&#xD;
&#xD;
        -  Presence of cardio-respiratory symptoms over 6-month follow-up&#xD;
&#xD;
        -  Cost of all home care services within 6 months of baseline&#xD;
&#xD;
      Secondary Outcomes:&#xD;
&#xD;
        -  Change in patient activation (based on 13 item patient activation measure) over 6-month&#xD;
           follow-up&#xD;
&#xD;
        -  Change in health-related quality of life (based on Minimum Data Set Health Status Index)&#xD;
           over 6-month follow-up&#xD;
&#xD;
        -  The difference in the number of unplanned emergency department visits per days at risk&#xD;
           (alive, not institutionalized) within 6 months of baseline&#xD;
&#xD;
        -  Number of unplanned inpatient (medical) hospital days per days at risk (alive, not&#xD;
           institutionalized) within 6 months of baseline&#xD;
&#xD;
      A 6-month follow-up will be used to reflect the time at greatest risk among home care&#xD;
      clients.&#xD;
&#xD;
      Sample calculations/Assumptions:&#xD;
&#xD;
      Primary outcome: Time to first unplanned emergency department visit within 6 months of&#xD;
      baseline (alive, not institutionalized). Ability to detect a hazard ratio of 0.75.&#xD;
&#xD;
      Mean size of a home care caseload: 120 clients Mean prevalence of DIVERT target group in each&#xD;
      caseload: 30% Expected recruitment over 6 months per caseload: 30 Mean cluster size: 30&#xD;
      Allocation: 1:2 (intervention: control)&#xD;
&#xD;
      Simulations using retrospective secondary data sources were undertaken to explore the power&#xD;
      of a hypothetical DIVERT-CARE trial conducted in the Hamilton-Niagara-Haldimand-Brant (HNHB)&#xD;
      health region of Ontario from December 2014 to June 2015. The simulations found that 60 HNHB&#xD;
      home care caseloads randomized at a 1:2 intervention to control ratio could expect to enroll&#xD;
      1,809 patients across seven months. The simulation linked patients to their actual emergency&#xD;
      department utilization records, and extended the time to first ED visit figures for patients&#xD;
      in 20 randomly selected intervention caseloads to achieve a hazard ratio of 0.75, a figure&#xD;
      chosen to be more conservative than the pilot study but still clinically significant. The&#xD;
      overall event rate was 35.5% in the intervention group and 44.8% in the control. The median&#xD;
      time to first visit was 88 days in the intervention group and 75 days in the control. The&#xD;
      power of the simulated DIVERT trial was 94.12% with a two-sided alpha of 0.05. Simulations&#xD;
      with a hazard ratio of 0.80 yielded a power of 79.96% The intracluster correlation&#xD;
      coefficient (ICC) was estimated to be 0.005.&#xD;
&#xD;
      Main Analyses:&#xD;
&#xD;
      The primary hypothesis will be assessed through a multilevel discrete-time proportional&#xD;
      hazards model. The dependent variable will be days until first emergency department visit,&#xD;
      censored at date of home care discharge for any reason. Caseload and partner site will be&#xD;
      included as nested random effects. The hazard ratio, 95% confidence interval, and p-value&#xD;
      will be reported for the treatment group effect and covariates when applicable. A two-sided&#xD;
      alpha level of 0.05 will be used to judge statistical significance.&#xD;
&#xD;
      The economic evaluation will examine total care costs, controlling for length of stay,&#xD;
      between treatment groups to compare incremental costs to incremental effects (i.e. cost per&#xD;
      ED visit averted).&#xD;
&#xD;
      The secondary hypotheses will be evaluated by a multilevel general linear model. Six-month&#xD;
      change in health-related quality of life, number of symptoms, patient activation, and number&#xD;
      of emergency department visits will be the respective dependent variables. Caseload and home&#xD;
      care provider site will be included as nested random effects. The unit change in each&#xD;
      measure, 95% confidence interval, and p-value will be reported for the treatment group effect&#xD;
      and covariates when applicable. A two-sided alpha level of 0.05 will be used to judge&#xD;
      statistical significance.&#xD;
&#xD;
      Main Secondary Datasets:&#xD;
&#xD;
      RAI-HC: The Resident Assessment Instrument Home Care (RAI-HC) is a standardized comprehensive&#xD;
      assessment containing approximately 200 items, has been found to document major domains of&#xD;
      health reliably. The Canadian Institute for Health Information (CIHI) collects and reports&#xD;
      this data from publically funded home care programs. CIHI conducts its own quality assurance&#xD;
      procedures to ensure accuracy and completeness. CIHI also provides a document describing the&#xD;
      interpretation of all included variables for the RAI-HC dataset.&#xD;
&#xD;
      The Client Health and Related Information System: The Client Health and Related Information&#xD;
      System (CHRIS) is an online patient management system for Community Care Access Centre (CCAC)&#xD;
      use. It includes patient assessments, documents, provider and vendor contracts, billing of&#xD;
      services information, and medical supplies and equipment rental costs. CHRIS continues to&#xD;
      maintain the quality and integrity of its data independently. Cost data from sites outside of&#xD;
      Ontario will be estimated as per the services rendered.&#xD;
&#xD;
      National Ambulatory Care Reporting System: The National Ambulatory Care Reporting System&#xD;
      (NACRS) contains data from all hospital-based and community-based ambulatory care. It is&#xD;
      collected and maintained by CIHI, which conducts its own quality assurance procedures to&#xD;
      ensure accuracy and completeness. CIHI also provides a document describing the interpretation&#xD;
      of all included variables for this dataset.&#xD;
&#xD;
      Discharge Abstract Database: The Discharge Abstract Database (DAD) captures administrative,&#xD;
      clinical and demographic information on hospital discharges (including deaths, sign-outs and&#xD;
      transfers). It is collected and maintained by CIHI, which conducts its own quality assurance&#xD;
      procedures to ensure accuracy and completeness. CIHI also provides a document describing the&#xD;
      interpretation of all included variables for this dataset.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2018</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in days to first unplanned emergency department visit (hazard rate)</measure>
    <time_frame>Up to six months from baseline</time_frame>
    <description>As identified from NACRS data set</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The difference in total care costs controlling for length of stay</measure>
    <time_frame>Up to six months from baseline</time_frame>
    <description>As identified in administrative (service cost) data sets</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in patient activation (patient activation questionnaire)</measure>
    <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
    <description>As identified from PAM measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The difference in the number of symptoms</measure>
    <time_frame>Baseline, 2 months, 4 months, 6 months</time_frame>
    <description>As identified from RAI-HC data set</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference in the number of unplanned emergency department visits</measure>
    <time_frame>Up to six months from baseline</time_frame>
    <description>As identified by NACRS data set</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of health-related quality of life (quality of life questionnaire)</measure>
    <time_frame>Baseline, 4 months, 6 months</time_frame>
    <description>As identified by RAI-HC</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">896</enrollment>
  <condition>Heart Failure</condition>
  <condition>Copd</condition>
  <arm_group>
    <arm_group_label>Cardio-respiratory management model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Additional home care management includes medication reconciliation, self-care education, advanced care planning, as well as physician communication and transfer protocols</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Home care (standard of care)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardio-respiratory management model</intervention_name>
    <description>Includes scheduled nurse-led self-management support (based on a training program, and tool-kit), advanced care and goal planning, clinical pharmacist education reconciliation, team case rounds, Situation, Background, Assessment and Recommendation (SBAR) communication protocol with primary care, and a standardized transition package</description>
    <arm_group_label>Cardio-respiratory management model</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Long-stay home care clients living in a noninstitutional setting (i.e. Admitted to&#xD;
             home care and receive comprehensive clinical assessment (RAI-HC))&#xD;
&#xD;
          -  DIVERT score of 9, 10, 14, or 15 (i.e. at least one cardio-respiratory symptom (chest&#xD;
             pain, dyspnea, dizziness, irregular pulse) and at least one cardiac condition&#xD;
             (congestive heart failure or coronary artery disease))&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clients receiving palliative care (i.e. Prognosis of less than six months to live at&#xD;
             time of assessment (Q. K8e from RAI-HC))&#xD;
&#xD;
          -  Clients receiving dialysis (Q. P2g from RAI-HC)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Costa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vancouver Island Health Authority</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 1J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Health</name>
      <address>
        <city>Corner Brook</city>
        <state>Newfoundland and Labrador</state>
        <zip>A2H 7E5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Niagara Haldimand Brant Local Health Integration Network</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8J 0G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Costa AP, Hirdes JP, Bell CM, Bronskill SE, Heckman GA, Mitchell L, Poss JW, Sinha SK, Stolee P. Derivation and validation of the detection of indicators and vulnerabilities for emergency room trips scale for classifying the risk of emergency department use in frail community-dwelling older adults. J Am Geriatr Soc. 2015 Apr;63(4):763-9. doi: 10.1111/jgs.13336.</citation>
    <PMID>25900490</PMID>
  </reference>
  <reference>
    <citation>Schumacher, C., Lackey, C., Haughton, D., Peirce, T., Boscart, V. M., Davey, M., Harkness, K., Heckman, G. A., Junek, M., McKelvie, R., Mitchell, L., Sinha, S. K., &amp; Costa, A. P. (2018). A chronic disease management model for home care patients with cardio-respiratory symptoms: the DIVERT-CARE Intervention. Canadian Journal of Cardiovascular Nursing, 28(3), 18-26.</citation>
  </reference>
  <reference>
    <citation>Costa AP, Schumacher C, Jones A, Dash D, Campbell G, Junek M, Agarwal G, Bell CM, Boscart V, Bronskill SE, Feeny D, Hebert PC, Heckman GA, Hirdes JP, Lee L, McKelvie RS, Mitchell L, Sinha SK, Davis J, Priddle T, Rose J, Gillan R, Mills D, Haughton D. DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care. BMJ Open. 2019 Dec 15;9(12):e030301. doi: 10.1136/bmjopen-2019-030301.</citation>
    <PMID>31843821</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Andrew Costa</investigator_full_name>
    <investigator_title>Assistant Professor and Schlegel Chair in Clinical Epidemiology &amp; Aging</investigator_title>
  </responsible_party>
  <keyword>Cardio-Respiratory Disease Management</keyword>
  <keyword>Chronic Disease Management</keyword>
  <keyword>Cluster-randomized Trial</keyword>
  <keyword>Multi-component Intervention</keyword>
  <keyword>DIVERT Scale</keyword>
  <keyword>Frail Elderly</keyword>
  <keyword>Interprofessional Care</keyword>
  <keyword>Pragmatic Trial</keyword>
  <keyword>Targeted Intervention</keyword>
  <keyword>Home Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All study data is from secondary sources including the RAI-HC dataset, electronic emergency department records and cost records. Privacy legislation prevents sharing.</ipd_description>
  </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/NCT03012256
org study id: 294080
nct id: NCT03012256
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale:

      In Canada, home care clients are a large and expanding subgroup of medically complex older
      adults with relatively poor access to effective chronic disease management. They have double
      the emergency department utilization rate compared to nursing home residents or other older
      populations. The investigators previously published a case-finding tool (the Detection of
      Indicators and Vulnerabilities for Emergency Room Trips (DIVERT) Scale) that has been
      recommended for chronic disease management case-finding in home care. The investigators
      recently conducted a pilot trial in Niagara, Canada, of a targeted, person-centered model of
      supportive cardio-respiratory disease management.

      Objectives:

      The investigators will evaluate a cardio-respiratory disease management model in home care to
      manage symptoms and avoid emergency department use. A pan-Canadian, pragmatic
      cluster-randomized trial will be conducted by a collaboration of trial investigators and
      public home care providers (i.e., health regions).

      The main objective is to evaluate the effectiveness and preliminary cost-effectiveness of a
      targeted, person-centered cardio-respiratory management model.

      The main question is:

      P: Among home care clients experiencing cardio-respiratory symptoms (objectively targeted
      using the DIVERT Scale), I: can a guideline-based, feasible, multi-component/complex,
      cardio-respiratory management model, C: compared to regular care, O: reduce
      cardio-respiratory symptoms, reduce/postpone unplanned emergency department (ED) visits,
      reduce unplanned hospital use, improve patient activation, or improve health-related quality
      of life for clients, T: over a 6-month follow-up period from baseline?
BACKGROUND

      Context:

      Public home care services are delivered to at least 6% of Canadians age 65-74, 15% age 75-84
      and 32% age 85 or older. These clients are medically complex, access care across settings,
      have very high emergency department utilization rates, and have relatively poor access to
      effective chronic disease management. Their frequent emergency department use is not aligned
      with chronic disease management or geriatric care principles.

      Effective chronic disease management models employ multiple components delivered by a
      coordinated multidisciplinary team. According to the 'chronic disease management model', home
      care plays a complementary function to medical practitioners. Clinical and self-care support
      as well as case management are among the most effective components in chronic disease
      management. Self-care education and support has been shown to improve health outcomes across
      chronic diseases. Sustained follow-up by nurses or other non-medical staff is also effective.

      Canadian home care providers, historically focused on the delivery of personal support
      services, have started to develop supportive chronic disease management capacity (e.g.
      specialist nurse monitoring). However, most trials exclude frail seniors and are not specific
      to home care, which leaves little evidence to inform chronic disease management practices.

      Previous Work:

      Effective chronic disease management in home care has been limited by insufficient targeting
      of clients at most need or most likely to benefit. The investigators developed and validated
      a prognostic case-finding tool for home care known as the Detection of Indicators and
      Vulnerabilities of Emergency Room Trips (DIVERT) Scale that has been recommended for home
      care. It can be derived in real time from the Resident Assessment Instrument-Home Care
      (RAI-HC) standardized home care assessment used in 9 Canadian provinces as well as Estonia,
      Finland, Hong Kong, Iceland, Ireland, Italy, Japan, the Netherlands, New Zealand, Singapore,
      Spain, Switzerland, and some U.S. states. Cardio-respiratory symptoms and conditions are
      prominent predictive elements of the DIVERT Scale.

      Based on evidence-based guidelines developed - in part - by the investigator team, the
      investigators piloted the combined use of the DIVERT Scale with a multi-component
      cardio-respiratory management model. The pilot pragmatic cluster randomized trial included
      over 200 clients across six home care caseloads. The pilot was recognized on the 2015 Ontario
      Minister's Medal Honour Role for Excellence in Health Quality.

      OBJECTIVES The main objective is to evaluate the effectiveness and preliminary
      cost-effectiveness of a targeted, person-centered cardio-respiratory management model.

      Research questions:

        1. Among home care clients experiencing cardio-respiratory symptoms (objectively targeted
           using the DIVERT Scale), can a guideline-based, feasible, multi-component/complex,
           cardio-respiratory management model, compared to regular care, reduce/postpone unplanned
           emergency department (ED) visits, improve patient activation, reduce cardio-respiratory
           symptoms, reduce unplanned hospital use, or improve health-related quality of life for
           clients, over a 6-month follow-up period from baseline?

        2. If effective, is there evidence for cost-effectiveness?

      METHODS

      Intervention:

      From evidence-based guidelines developed - in part - by this team, extensive client
      profiling, and input of clients/families as well as health professionals, the investigators
      developed a person-centred, multi-component cardio-respiratory management model containing
      the following components: scheduled nurse-led self-management support (based on a training
      program, and tool-kit), advanced care and goal planning, clinical pharmacist medication
      reconciliation, team case rounds, SBAR (the Situation, Background, Assessment and
      Recommendation) communication protocol with primary care, and a standardized transition
      package. Each component has a specific objective within the model, however the manner in
      which it is delivered may be adapted. The approach is based on evidence of effective
      implementations in other fields, and includes all elements for 'person-centred care'.

      Design:

      The investigators will conduct a pragmatic, cluster-randomized trial that leverages secondary
      electronic patient records. Sixty-six (66) geographic areas (home care caseloads) will be
      randomized using a 1:2 (intervention: control) ratio.

      Population:

      Approximately 1,080 long-stay home care clients living in a non-institutional setting from 66
      distinct geographic home care caseloads in Canada. Inclusion criteria: clients who are in the
      DIVERT Scale target groups (9,10, 14, 15) will be included (i.e. at least one
      cardio-respiratory symptom (chest pain, dyspnea, dizziness, irregular pulse) and at least one
      cardiac condition (congestive heart failure or coronary artery disease)). The investigators
      will utilize the DIVERT Scale as an objective measure of eligibility. Clients who are
      receiving palliative care (i.e., prognosis of less than six months to live, K8e from Resident
      Assessment Instrument-Home Care (RAI-HC)) or dialysis (P2g from RAI-HC) at baseline
      assessment will be excluded.

      Recruitment:

      Eligible clients will be identified by each case manager during regular home care enrollment
      and reassessment using the RAI-HC assessment (standard practice) for between 6 to 8 months.
      Eligible clients will be automatically included into the intervention or 'regular care'
      control on an intent-to-treat basis. Each home care provider's process for attaining consent
      to intervention will apply. Study informed consent will not be sought given that the
      cardio-respiratory management model is considered best practice care and is offered - whole
      or in part - at the full clinical discretion of the home care provider as per existing
      practice. The cardio-respiratory management is accepted - whole or in part - at the full
      clinical discretion of the clients as per existing practice. Trial investigators have no part
      in the intervention pilot data collection, individual care decision-making, or records
      management during the study period beyond providing guidance and access to resources. All
      trial data will be extracted from secondary data and anonymized prior to transmission by home
      care provider staff.

      Outcomes and Follow-up:

      Primary Outcomes:

        -  Difference in days to first unplanned emergency department visit within 6 months of
           baseline

        -  Presence of cardio-respiratory symptoms over 6-month follow-up

        -  Cost of all home care services within 6 months of baseline

      Secondary Outcomes:

        -  Change in patient activation (based on 13 item patient activation measure) over 6-month
           follow-up

        -  Change in health-related quality of life (based on Minimum Data Set Health Status Index)
           over 6-month follow-up

        -  The difference in the number of unplanned emergency department visits per days at risk
           (alive, not institutionalized) within 6 months of baseline

        -  Number of unplanned inpatient (medical) hospital days per days at risk (alive, not
           institutionalized) within 6 months of baseline

      A 6-month follow-up will be used to reflect the time at greatest risk among home care
      clients.

      Sample calculations/Assumptions:

      Primary outcome: Time to first unplanned emergency department visit within 6 months of
      baseline (alive, not institutionalized). Ability to detect a hazard ratio of 0.75.

      Mean size of a home care caseload: 120 clients Mean prevalence of DIVERT target group in each
      caseload: 30% Expected recruitment over 6 months per caseload: 30 Mean cluster size: 30
      Allocation: 1:2 (intervention: control)

      Simulations using retrospective secondary data sources were undertaken to explore the power
      of a hypothetical DIVERT-CARE trial conducted in the Hamilton-Niagara-Haldimand-Brant (HNHB)
      health region of Ontario from December 2014 to June 2015. The simulations found that 60 HNHB
      home care caseloads randomized at a 1:2 intervention to control ratio could expect to enroll
      1,809 patients across seven months. The simulation linked patients to their actual emergency
      department utilization records, and extended the time to first ED visit figures for patients
      in 20 randomly selected intervention caseloads to achieve a hazard ratio of 0.75, a figure
      chosen to be more conservative than the pilot study but still clinically significant. The
      overall event rate was 35.5% in the intervention group and 44.8% in the control. The median
      time to first visit was 88 days in the intervention group and 75 days in the control. The
      power of the simulated DIVERT trial was 94.12% with a two-sided alpha of 0.05. Simulations
      with a hazard ratio of 0.80 yielded a power of 79.96% The intracluster correlation
      coefficient (ICC) was estimated to be 0.005.

      Main Analyses:

      The primary hypothesis will be assessed through a multilevel discrete-time proportional
      hazards model. The dependent variable will be days until first emergency department visit,
      censored at date of home care discharge for any reason. Caseload and partner site will be
      included as nested random effects. The hazard ratio, 95% confidence interval, and p-value
      will be reported for the treatment group effect and covariates when applicable. A two-sided
      alpha level of 0.05 will be used to judge statistical significance.

      The economic evaluation will examine total care costs, controlling for length of stay,
      between treatment groups to compare incremental costs to incremental effects (i.e. cost per
      ED visit averted).

      The secondary hypotheses will be evaluated by a multilevel general linear model. Six-month
      change in health-related quality of life, number of symptoms, patient activation, and number
      of emergency department visits will be the respective dependent variables. Caseload and home
      care provider site will be included as nested random effects. The unit change in each
      measure, 95% confidence interval, and p-value will be reported for the treatment group effect
      and covariates when applicable. A two-sided alpha level of 0.05 will be used to judge
      statistical significance.

      Main Secondary Datasets:

      RAI-HC: The Resident Assessment Instrument Home Care (RAI-HC) is a standardized comprehensive
      assessment containing approximately 200 items, has been found to document major domains of
      health reliably. The Canadian Institute for Health Information (CIHI) collects and reports
      this data from publically funded home care programs. CIHI conducts its own quality assurance
      procedures to ensure accuracy and completeness. CIHI also provides a document describing the
      interpretation of all included variables for the RAI-HC dataset.

      The Client Health and Related Information System: The Client Health and Related Information
      System (CHRIS) is an online patient management system for Community Care Access Centre (CCAC)
      use. It includes patient assessments, documents, provider and vendor contracts, billing of
      services information, and medical supplies and equipment rental costs. CHRIS continues to
      maintain the quality and integrity of its data independently. Cost data from sites outside of
      Ontario will be estimated as per the services rendered.

      National Ambulatory Care Reporting System: The National Ambulatory Care Reporting System
      (NACRS) contains data from all hospital-based and community-based ambulatory care. It is
      collected and maintained by CIHI, which conducts its own quality assurance procedures to
      ensure accuracy and completeness. CIHI also provides a document describing the interpretation
      of all included variables for this dataset.

      Discharge Abstract Database: The Discharge Abstract Database (DAD) captures administrative,
      clinical and demographic information on hospital discharges (including deaths, sign-outs and
      transfers). It is collected and maintained by CIHI, which conducts its own quality assurance
      procedures to ensure accuracy and completeness. CIHI also provides a document describing the
      interpretation of all included variables for this dataset.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The difference in days to first unplanned emergency department visit (hazard rate)
time frame: Up to six months from baseline
description: As identified from NACRS data set
measure: The difference in total care costs controlling for length of stay
time frame: Up to six months from baseline
description: As identified in administrative (service cost) data sets
measure: Changes in patient activation (patient activation questionnaire)
time frame: Baseline, 2 months, 4 months, 6 months
description: As identified from PAM measure
measure: The difference in the number of symptoms
time frame: Baseline, 2 months, 4 months, 6 months
description: As identified from RAI-HC data set
measure: The difference in the number of unplanned emergency department visits
time frame: Up to six months from baseline
description: As identified by NACRS data set
measure: Description of health-related quality of life (quality of life questionnaire)
time frame: Baseline, 4 months, 6 months
description: As identified by RAI-HC
arm group label: Cardio-respiratory management model
arm group type: Experimental
description: Additional home care management includes medication reconciliation, self-care education, advanced care planning, as well as physician communication and transfer protocols
arm group label: Control
arm group type: No Intervention
description: Home care (standard of care)
intervention type: Other
intervention name: Cardio-respiratory management model
description: Includes scheduled nurse-led self-management support (based on a training program, and tool-kit), advanced care and goal planning, clinical pharmacist education reconciliation, team case rounds, Situation, Background, Assessment and Recommendation (SBAR) communication protocol with primary care, and a standardized transition package
arm group label: Cardio-respiratory management model
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Costa, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
facility: 
facility: 
country: Canada
citation: Costa AP, Hirdes JP, Bell CM, Bronskill SE, Heckman GA, Mitchell L, Poss JW, Sinha SK, Stolee P. Derivation and validation of the detection of indicators and vulnerabilities for emergency room trips scale for classifying the risk of emergency department use in frail community-dwelling older adults. J Am Geriatr Soc. 2015 Apr;63(4):763-9. doi: 10.1111/jgs.13336.
PMID: 25900490
citation: Schumacher, C., Lackey, C., Haughton, D., Peirce, T., Boscart, V. M., Davey, M., Harkness, K., Heckman, G. A., Junek, M., McKelvie, R., Mitchell, L., Sinha, S. K., & Costa, A. P. (2018). A chronic disease management model for home care patients with cardio-respiratory symptoms: the DIVERT-CARE Intervention. Canadian Journal of Cardiovascular Nursing, 28(3), 18-26.
citation: Costa AP, Schumacher C, Jones A, Dash D, Campbell G, Junek M, Agarwal G, Bell CM, Boscart V, Bronskill SE, Feeny D, Hebert PC, Heckman GA, Hirdes JP, Lee L, McKelvie RS, Mitchell L, Sinha SK, Davis J, Priddle T, Rose J, Gillan R, Mills D, Haughton D. DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care. BMJ Open. 2019 Dec 15;9(12):e030301. doi: 10.1136/bmjopen-2019-030301.
PMID: 31843821
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Andrew Costa
investigator title: Assistant Professor and Schlegel Chair in Clinical Epidemiology & Aging
mesh term: Heart Failure
sharing ipd: No
ipd description: All study data is from secondary sources including the RAI-HC dataset, electronic emergency department records and cost records. Privacy legislation prevents sharing.