xml: <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/NCT06034444</url>
    </required_header>
    <id_info>
      <org_study_id>17.205</org_study_id>
      <nct_id>NCT06034444</nct_id>
    </id_info>
    <brief_title>Better tArgetting, Better Outcomes for Frail ELderly Patients</brief_title>
    <acronym>BABEL</acronym>
    <official_title>Better tArgetting, Better Outcomes for Frail ELderly Patients: A Quality Improvement Initiative in Long-term Care Facilities Using interRAI Long-term Care Assessment in Quebec</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Canadian Frailty Network</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre hospitalier de l'Université de Montréal (CHUM)</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>
        The acronym for this proposal, BABEL, refers to the fact that a common &quot;language&quot; - the&#xD;
        interRAI risk-stratification and decision-making tool - will be used in this project,&#xD;
        allowing several measures of care quality in long-term care facilities to be compared with&#xD;
        those in other provinces for the first time. The impact of the use of this assessment system&#xD;
        and associated care planning protocols will also be investigated using usual practice as the&#xD;
        point of reference.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 16, 2018</start_date>
    <completion_date type="Actual">March 31, 2020</completion_date>
    <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in depression prevalence</measure>
      <time_frame>Every 3 months, for a minimum of 6 months and a maximum of 36 months</time_frame>
      <description>Depression rating scale score of 3 or more (from interRAI LTCF)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in prevalence of potentially inappropriate antipsychotic use</measure>
      <time_frame>Every 3 months, for a minimum of 6 months and a maximum of 36 months</time_frame>
      <description>Use of antipsychotics in the absence of an appropriate diagnosis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in falls prevalence</measure>
      <time_frame>Every 3 months, for a minimum of 6 months and a maximum of 36 months</time_frame>
      <description>Prevalence of falls among residents under study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in prevalence of pain</measure>
      <time_frame>Every 3 months, for a minimum of 6 months and a maximum of 36 months</time_frame>
      <description>Using interRAI pain scale scores greater than 0</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in the prevalence of physical restraints use</measure>
      <time_frame>Every 3 months, for a minimum of 6 months and a maximum of 36 months</time_frame>
      <description>Use of physical restraints on residents as assessed using interRAI LTCF</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in prevalence of pressure ulcers</measure>
      <time_frame>Every 3 months, for a minimum of 6 months and a maximum of 36 months</time_frame>
      <description>Stage 2 pressure ulcer on the interRAI pressure ulcer scale</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in other interRAI LTCF quality indicators</measure>
      <time_frame>Every 3 months, for a minimum of 6 months and a maximum of 36 months</time_frame>
      <description>interRAI LTCF evaluation leads to a number of quality indicators being generated each of which will be tracked over time for each facility to compare before and after effects, as well as comparisons with other centers in Canada</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">5692</enrollment>
    <condition>Residents in Longterm Care Facilities</condition>
    <arm_group>
      <arm_group_label>interRAI LTCF</arm_group_label>
      <description>Nursing homes in Quebec where interRAI evaluations and care plans will be introduced.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>interRAI LTCF</intervention_name>
      <description>Standardized evaluations (interRAI LTCF) will be introduced to selected nursing homes in Quebec.</description>
      <arm_group_label>interRAI LTCF</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Residents in a long-term care facility (nursing home)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All nursing home residents in a particular unit where standardized evaluations are&#xD;
               being introduced (for example, all residents in a particular floor or wing of the&#xD;
               longterm care facility)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Residents who are admitted to a nursing home unit for less than 1 week.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Donald Berman Maimonides</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H4W 2Y6</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 20, 2018</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034444
  org study id: 17.205
  nct id: NCT06034444
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The acronym for this proposal, BABEL, refers to the fact that a common "language" - the
        interRAI risk-stratification and decision-making tool - will be used in this project,
        allowing several measures of care quality in long-term care facilities to be compared with
        those in other provinces for the first time. The impact of the use of this assessment system
        and associated care planning protocols will also be investigated using usual practice as the
        point of reference.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in depression prevalence
  time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
  description: Depression rating scale score of 3 or more (from interRAI LTCF)
  measure: Change in prevalence of potentially inappropriate antipsychotic use
  time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
  description: Use of antipsychotics in the absence of an appropriate diagnosis
  measure: Change in falls prevalence
  time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
  description: Prevalence of falls among residents under study
  measure: Change in prevalence of pain
  time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
  description: Using interRAI pain scale scores greater than 0
  measure: Change in the prevalence of physical restraints use
  time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
  description: Use of physical restraints on residents as assessed using interRAI LTCF
  measure: Change in prevalence of pressure ulcers
  time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
  description: Stage 2 pressure ulcer on the interRAI pressure ulcer scale
  measure: Change in other interRAI LTCF quality indicators
  time frame: Every 3 months, for a minimum of 6 months and a maximum of 36 months
  description: interRAI LTCF evaluation leads to a number of quality indicators being generated each of which will be tracked over time for each facility to compare before and after effects, as well as comparisons with other centers in Canada
  arm group label: interRAI LTCF
  description: Nursing homes in Quebec where interRAI evaluations and care plans will be introduced.
  intervention type: Other
  intervention name: interRAI LTCF
  description: Standardized evaluations (interRAI LTCF) will be introduced to selected nursing homes in Quebec.
  arm group label: interRAI LTCF
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Canada
  responsible party type: Sponsor