<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/NCT03807466</url>
  </required_header>
  <id_info>
    <org_study_id>441-2017</org_study_id>
    <nct_id>NCT03807466</nct_id>
  </id_info>
  <brief_title>Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term Care</brief_title>
  <acronym>FIRST AID-LTC</acronym>
  <official_title>Feedback to Improve Rational Strategies of Antibiotic Initiation and Duration in Long Term</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Clinical Evaluative Sciences</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>Ontario Agency for Health Protection and Promotion</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Quality Ontario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute for Clinical Evaluative Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a high rate of inappropriate antibiotic use in long-term care (LTC) facilities, with&#xD;
      both unnecessary initiation and prolongation of treatments. Although there are challenges to&#xD;
      rational antibiotic use in LTC, the variability in antibiotic initiation and use of prolonged&#xD;
      treatment durations is driven by prescriber tendencies rather than resident characteristics.&#xD;
      Audit-and-feedback is a well-established intervention to improve professional practices, and&#xD;
      is ideally suited for use to improve antibiotic prescribing tendencies in LTC. The literature&#xD;
      is saturated with trials indicating benefit of audit-and-feedback, but is in dire need of&#xD;
      studies to identify methods to improve the impact of this technique. Health Quality Ontario&#xD;
      (HQO), a key partner in the FIRST AID-LTC research program, is already providing&#xD;
      audit-and-feedback for other inappropriate prescribing practices in LTC, and has identified&#xD;
      antibiotic prescribing as a priority focus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overarching Goals&#xD;
&#xD;
      The overarching goals of FIRST AID - LTC are two-fold:&#xD;
&#xD;
        1. Improve rational antibiotic prescribing by physicians to minimize harms among LTC&#xD;
           residents.&#xD;
&#xD;
        2. Advance the science of audit-and-feedback to improve physician prescribing practices.&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
      To improve rational antibiotic prescribing in LTC:&#xD;
&#xD;
        1. by decreasing unnecessary initiation of antibiotic treatments among Ontario LTC&#xD;
           residents, as well as the variability in initiation rates across LTC prescribers.&#xD;
&#xD;
        2. by decreasing unnecessary prolonged duration of antibiotic treatments among Ontario LTC&#xD;
           residents, as well as the variability in prolonged duration treatment use across LTC&#xD;
           prescribers.&#xD;
&#xD;
      To advance audit-and-feedback implementation science:&#xD;
&#xD;
      1. by evaluating whether a dynamic audit-and-feedback report highlighting antibiotic&#xD;
      prescribing can lead to greater reductions in antibiotic use, than a static paginated report&#xD;
&#xD;
      Anticipated Contributions to Health-Related Knowledge&#xD;
&#xD;
      Although the literature is inundated with trials examining the impact of audit-and-feedback&#xD;
      compared to usual care, there is a need for studies to improve audit-and-feedback delivery.&#xD;
      FIRST AID-LTC will test optimal delivery and peer comparison techniques for&#xD;
      audit-and-feedback. The knowledge learned can be extrapolated to antibiotic interventions in&#xD;
      LTC in other provinces across Canada, as well more broadly to inappropriate medication&#xD;
      prescribing practices in LTC.&#xD;
&#xD;
      Anticipated Contributions to Health Care, Health Systems and Health Outcomes&#xD;
&#xD;
      FIRST AID-LTC will lead to immediate reductions in excess antibiotic use in Ontario LTC&#xD;
      facilities, which in turn should result in substantial reductions in direct drug costs, as&#xD;
      well as downstream complications of allergy, organ toxicity, C. difficile infections and&#xD;
      antimicrobial resistance. With easy transferability to other Canadian provinces, the&#xD;
      improvements in cost-savings and patient outcomes could be massive in scope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 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>
    <intervention_model_description>Assess two interventional parallel study models consisting of two intervention arms each</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The team at Health Quality Ontario will be aware of the physicians' assignment to dynamic versus paginated reports so that they can send the correct audit-and-feedback document. However, the analytic team at ICES will be masked, and outcome data will be extracted by the analysis team from routinely collected administrative databases (Ontario drug benefits database).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Antibiotic initiation</measure>
    <time_frame>3 months</time_frame>
    <description>Median % of patients initiated on an antibiotic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antibiotic duration</measure>
    <time_frame>3 months</time_frame>
    <description>Median % of antibiotic treatments prolonged &gt;7 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ER visit or hospitalization for infection</measure>
    <time_frame>3 months</time_frame>
    <description>The percentage of a LTC physicians' patients that experienced an ER visit or hospitalization due to a potential antibiotic-related harm, including: allergy, general medication adverse event, diarrhea, C. difficile infection, or infection with an antibiotic-resistant organism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ER visit or hospitalization for antibiotic harms</measure>
    <time_frame>3 months</time_frame>
    <description>To test for harms related to decreased antibiotic use by comparing the percentage of LTC physicians' patients that experience an infection-related ER visit or admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Net Clinical impact</measure>
    <time_frame>3 months</time_frame>
    <description>Measure the net clinical impact of the intervention, by comparing all-cause ER visits and hospitalizations and mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-psychotic use</measure>
    <time_frame>3 months</time_frame>
    <description>The percent reduction in anti-psychotic use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benzodiazepine use</measure>
    <time_frame>3 months</time_frame>
    <description>The percent reduction in benzodiazepines</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">356</enrollment>
  <condition>Antibiotic Initiation</condition>
  <condition>Antibiotic Duration</condition>
  <arm_group>
    <arm_group_label>Dynamic/Interactive Report</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LTC physician receives dynamic/interactive report only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Static/Paginated Report</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>LTC physician receives static/paginated report only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LTC Physicians Enrolled in Reports</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All LTC physicians who receive a dynamic or paginated report&#xD;
[note: this is not part of randomization assignment, but a quasi-experimental study]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LTC Physicians Not Enrolled in Reports</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All LTC physicians who do not receive a dynamic or paginated report&#xD;
[note: this is not part of randomization assignment, but a quasi-experimental study]</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dynamic/Interactive vs. Static/Paginated Report</intervention_name>
    <description>Evaluate whether a stand-alone interactive audit-and-feedback report highlighting antibiotic prescribing can lead to greater reductions in antibiotic use, than a report embedded in a broader static feedback system</description>
    <arm_group_label>Dynamic/Interactive Report</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LTC Physicians Enrolled vs. Not Enrolled in Reports</intervention_name>
    <description>Evaluate whether being provided an audit-and-feedback report (regardless of dynamic or static) can lead to greater reductions in antibiotic use, than those who do not receive either report</description>
    <arm_group_label>LTC Physicians Enrolled in Reports</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        To Identify an LTC Resident&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        An individual having a minimum of 2 records on separate days within the quarter meeting any&#xD;
        combination of the following criteria:&#xD;
&#xD;
          -  a record for a non-emergency long-term care inpatient services OR&#xD;
&#xD;
          -  an Ontario Drug Benefits record administered in long-term care&#xD;
&#xD;
        Index date = The analysis will be anchored on the most recent of either of the records&#xD;
        above within a given quarter or their date of death (whichever date is earliest)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-Ontario resident at index date&#xD;
&#xD;
          -  Invalid age (age&lt;19 or age&gt;115) at index date&#xD;
&#xD;
          -  Missing or invalid sex or date of birth at index date&#xD;
&#xD;
          -  Death date is &gt;7 days before index date&#xD;
&#xD;
          -  If the individual does not live in a nursing home or home for the aged&#xD;
&#xD;
          -  Cannot be linked to a Most Responsible Physician (MRP) (see methodology below)&#xD;
&#xD;
        To Identify the Most Responsible Physician (MRP) Using Virtual Rostering&#xD;
&#xD;
        For each patient in the above resident cohort, the study team will retrieve all records&#xD;
        from health care providers in the 6 month period preceding the index date (180 days),&#xD;
        keeping only records from physicians who have a specialty of 1) general practice, 2)&#xD;
        community medicine or 3) geriatrics.&#xD;
&#xD;
        Steps for MRP assignment:&#xD;
&#xD;
        Step 1) The study team will first select physicians with the highest count of records for&#xD;
        the monthly management of a nursing home or home for the aged. This is completed for as&#xD;
        many residents as possible.&#xD;
&#xD;
        Step 2) If there were no monthly management fee records as described above then the&#xD;
        physician with highest count of non-emergency long-term care inpatient services records for&#xD;
        each patient will be selected. This step is only applied to residents who could not be&#xD;
        matched to a physician by Step 1. **Physician must have seen the patient one or more times&#xD;
        in 90 days prior to and including index date to be considered MRP. This criteria is applied&#xD;
        to ensure the physician has seen the resident within the reporting quarter.&#xD;
&#xD;
        Step 3) Some patients will virtually roster to physicians in Enrollment groups, some will&#xD;
        virtually roster to physicians that are not in a group. For these, the study team will&#xD;
        recode enrollment program type to 'NOR' (not otherwise rostered) - these are likely fee for&#xD;
        service physicians.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nick Daneman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICES</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ICES</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute for Clinical Evaluative Sciences</investigator_affiliation>
    <investigator_full_name>Nick Daneman</investigator_full_name>
    <investigator_title>Adjunct Scientist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03807466
org study id: 441-2017
nct id: NCT03807466
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a high rate of inappropriate antibiotic use in long-term care (LTC) facilities, with
      both unnecessary initiation and prolongation of treatments. Although there are challenges to
      rational antibiotic use in LTC, the variability in antibiotic initiation and use of prolonged
      treatment durations is driven by prescriber tendencies rather than resident characteristics.
      Audit-and-feedback is a well-established intervention to improve professional practices, and
      is ideally suited for use to improve antibiotic prescribing tendencies in LTC. The literature
      is saturated with trials indicating benefit of audit-and-feedback, but is in dire need of
      studies to identify methods to improve the impact of this technique. Health Quality Ontario
      (HQO), a key partner in the FIRST AID-LTC research program, is already providing
      audit-and-feedback for other inappropriate prescribing practices in LTC, and has identified
      antibiotic prescribing as a priority focus.
Overarching Goals

      The overarching goals of FIRST AID - LTC are two-fold:

        1. Improve rational antibiotic prescribing by physicians to minimize harms among LTC
           residents.

        2. Advance the science of audit-and-feedback to improve physician prescribing practices.

      Specific Aims

      To improve rational antibiotic prescribing in LTC:

        1. by decreasing unnecessary initiation of antibiotic treatments among Ontario LTC
           residents, as well as the variability in initiation rates across LTC prescribers.

        2. by decreasing unnecessary prolonged duration of antibiotic treatments among Ontario LTC
           residents, as well as the variability in prolonged duration treatment use across LTC
           prescribers.

      To advance audit-and-feedback implementation science:

      1. by evaluating whether a dynamic audit-and-feedback report highlighting antibiotic
      prescribing can lead to greater reductions in antibiotic use, than a static paginated report

      Anticipated Contributions to Health-Related Knowledge

      Although the literature is inundated with trials examining the impact of audit-and-feedback
      compared to usual care, there is a need for studies to improve audit-and-feedback delivery.
      FIRST AID-LTC will test optimal delivery and peer comparison techniques for
      audit-and-feedback. The knowledge learned can be extrapolated to antibiotic interventions in
      LTC in other provinces across Canada, as well more broadly to inappropriate medication
      prescribing practices in LTC.

      Anticipated Contributions to Health Care, Health Systems and Health Outcomes

      FIRST AID-LTC will lead to immediate reductions in excess antibiotic use in Ontario LTC
      facilities, which in turn should result in substantial reductions in direct drug costs, as
      well as downstream complications of allergy, organ toxicity, C. difficile infections and
      antimicrobial resistance. With easy transferability to other Canadian provinces, the
      improvements in cost-savings and patient outcomes could be massive in scope.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Assess two interventional parallel study models consisting of two intervention arms each
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The team at Health Quality Ontario will be aware of the physicians' assignment to dynamic versus paginated reports so that they can send the correct audit-and-feedback document. However, the analytic team at ICES will be masked, and outcome data will be extracted by the analysis team from routinely collected administrative databases (Ontario drug benefits database).
measure: Antibiotic initiation
time frame: 3 months
description: Median % of patients initiated on an antibiotic
measure: Antibiotic duration
time frame: 3 months
description: Median % of antibiotic treatments prolonged >7 days
measure: ER visit or hospitalization for infection
time frame: 3 months
description: The percentage of a LTC physicians' patients that experienced an ER visit or hospitalization due to a potential antibiotic-related harm, including: allergy, general medication adverse event, diarrhea, C. difficile infection, or infection with an antibiotic-resistant organism
measure: ER visit or hospitalization for antibiotic harms
time frame: 3 months
description: To test for harms related to decreased antibiotic use by comparing the percentage of LTC physicians' patients that experience an infection-related ER visit or admission
measure: Net Clinical impact
time frame: 3 months
description: Measure the net clinical impact of the intervention, by comparing all-cause ER visits and hospitalizations and mortality
measure: Anti-psychotic use
time frame: 3 months
description: The percent reduction in anti-psychotic use
measure: Benzodiazepine use
time frame: 3 months
description: The percent reduction in benzodiazepines
arm group label: Dynamic/Interactive Report
arm group type: Active Comparator
description: LTC physician receives dynamic/interactive report only
arm group label: Static/Paginated Report
arm group type: No Intervention
description: LTC physician receives static/paginated report only
arm group label: LTC Physicians Enrolled in Reports
arm group type: Active Comparator
description: All LTC physicians who receive a dynamic or paginated report
[note: this is not part of randomization assignment, but a quasi-experimental study]
arm group label: LTC Physicians Not Enrolled in Reports
arm group type: No Intervention
description: All LTC physicians who do not receive a dynamic or paginated report
[note: this is not part of randomization assignment, but a quasi-experimental study]
intervention type: Behavioral
intervention name: Dynamic/Interactive vs. Static/Paginated Report
description: Evaluate whether a stand-alone interactive audit-and-feedback report highlighting antibiotic prescribing can lead to greater reductions in antibiotic use, than a report embedded in a broader static feedback system
arm group label: Dynamic/Interactive Report
intervention type: Behavioral
intervention name: LTC Physicians Enrolled vs. Not Enrolled in Reports
description: Evaluate whether being provided an audit-and-feedback report (regardless of dynamic or static) can lead to greater reductions in antibiotic use, than those who do not receive either report
arm group label: LTC Physicians Enrolled in Reports
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nick Daneman, MD
role: Principal Investigator
affiliation: ICES
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Institute for Clinical Evaluative Sciences
investigator full name: Nick Daneman
investigator title: Adjunct Scientist
sharing ipd: No