<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/NCT03022929</url>
  </required_header>
  <id_info>
    <org_study_id>986083</org_study_id>
    <secondary_id>971471</secondary_id>
    <nct_id>NCT03022929</nct_id>
  </id_info>
  <brief_title>A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings</brief_title>
  <acronym>MITIGATE</acronym>
  <official_title>A Multifaceted Intervention to Improve Prescribing for Acute Respiratory Infection for Adults and Children in Emergency Department and Urgent Care Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inappropriate antibiotic use is a major public health concern. Excessive exposure to&#xD;
      antibiotics results in emergence and spread of drug-resistant bacteria, potentially avoidable&#xD;
      adverse drug reactions, and increased healthcare utilization and cost. As antibiotic&#xD;
      prescribing in emergency departments and urgent care centers remains unchecked, national&#xD;
      professional organizations including the Infectious Diseases Society of America (IDSA) and&#xD;
      the Society for Healthcare Epidemiology (SHEA), and an Executive Order from the President of&#xD;
      the United States, recommend expansion of antimicrobial stewardship to these ambulatory care&#xD;
      settings. The goal of antimicrobial stewardship is to effectively promote judicious&#xD;
      antibiotic use in all healthcare settings, yet stewardship programs have not achieved their&#xD;
      potential in terms of either reach or effectiveness. Reach has been limited by implementation&#xD;
      mostly in inpatient settings; at the same time, recent critical experiments in behavioral&#xD;
      science suggest that the effectiveness of existing stewardship programs could be greatly&#xD;
      augmented through inclusion of behavioral nudges, benchmarked audit and feedback, and&#xD;
      peer-to-peer comparisons.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this proposed acute care project, the investigators will compare a package consisting of&#xD;
      education for providers using existing materials from Center for Disease Control and&#xD;
      Prevention's (CDC) GetSmart campaign adapted for the acute care setting led by a physician&#xD;
      champion at each site (the adapted intervention), to a more intensive intervention that&#xD;
      incorporates adapted GetSmart materials enhanced with individualized audit and feedback, peer&#xD;
      comparisons, and behavioral nudges (the enhanced intervention). The comparative effectiveness&#xD;
      of the enhanced intervention will be evaluated in a multicenter cluster randomized trial&#xD;
      nested within a quasi-experimental study of acute care stewardship. The investigators'&#xD;
      hypothesis is that both interventions will reduce inappropriate antibiotic prescribing for&#xD;
      antibiotic nonresponsive acute respiratory infections (ARIs) in emergency departments and&#xD;
      urgent care centers, but that the enhanced one will be more effective. The investigators will&#xD;
      use an interrupted time series study design to measure the impact of their interventions&#xD;
      against the baseline period of usual care as well as against seasonally-adjusted historical&#xD;
      controls. The cluster randomized design for the two types of acute care stewardship&#xD;
      interventions will allow measurement of the difference- in-differences in antibiotic&#xD;
      prescribing rates for acute bronchitis, acute bronchiolitis, viral pharyngitis, influenza,&#xD;
      and nonspecific upper respiratory infection (URI). Translation of proven behavioral&#xD;
      techniques is a new and innovative approach to improving prescribing decisions. This project&#xD;
      will expand stewardship to a new setting using innovative and effective approaches including&#xD;
      the adaptation of behavioral techniques for emergency department (ED) and urgent care&#xD;
      settings. The investigators will also further establish their research group as a network for&#xD;
      developing novel tools, measuring outcomes for antimicrobial stewardship, and disseminating&#xD;
      research findings through acute care setting-specific toolkits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">September 24, 2018</completion_date>
  <primary_completion_date type="Actual">September 24, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Antibiotic Prescribing Trends</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The investigators will measure the likelihood that an antibiotic is prescribed in an antibiotic-nonresponsive acute respiratory infection visit.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">257</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Adapted Intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The investigators will use GetSmart materials published by the CDC appropriate to the emergency department and urgent care settings and select and adapt brochures and other campaign messages for acute care providers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigators will use all of the methods of the Adapted Intervention. In addition to these methods, the investigators will add posters within exam rooms which will include modified GetSmart content and other nudges such as physician pictures with their signed public commitment to antibiotic stewardship or flair denoting commitment to stewardship. The investigators will also provide physicians with personalized monthly performance ranking with each physician receiving the designation of &quot;top performer&quot; or &quot;not a top performer&quot; based on their appropriate antibiotic prescribing practices for acute respiratory infections. This will be the Enhanced Antimicrobial Stewardship Commitment and Feedback intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Antimicrobial Stewardship Commitment and Feedback</intervention_name>
    <description>Goes beyond the GetSmart recommendations to discern whether these recommendations can be improved upon.</description>
    <arm_group_label>Enhanced Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Clinicians will be eligible for the study if they meet the following Inclusion Criteria:&#xD;
&#xD;
          1. Must be a clinician at one of the study sites.&#xD;
&#xD;
          2. Must treat adult and/or pediatric patients with an acute respiratory infections.&#xD;
&#xD;
        Individual patient encounters will be ineligible for analysis if they meet any of the&#xD;
        following Exclusion Criteria:&#xD;
&#xD;
          1. Medical co-morbidities that make acute respiratory infection (ARI) guidelines less&#xD;
             likely to apply.&#xD;
&#xD;
          2. Concomitant visit diagnoses indicating a non-ARI possible bacterial infection.&#xD;
&#xD;
          3. Concomitant visit diagnoses indicating potentially antibiotic appropriate ARI.&#xD;
             diagnoses or other ARI diagnoses suggestive of a bacterial infection.&#xD;
&#xD;
          4. Visit occurred within 30 days of an earlier ARI diagnosis.&#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>Larissa S May, MD,MSPH,MSHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor and Director of Emergency Department Antibiotic Stewardship</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Harbor Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD planned.</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/NCT03022929
org study id: 986083
secondary id: 971471
nct id: NCT03022929
lead sponsor: 
has dmc: Yes
Inappropriate antibiotic use is a major public health concern. Excessive exposure to
      antibiotics results in emergence and spread of drug-resistant bacteria, potentially avoidable
      adverse drug reactions, and increased healthcare utilization and cost. As antibiotic
      prescribing in emergency departments and urgent care centers remains unchecked, national
      professional organizations including the Infectious Diseases Society of America (IDSA) and
      the Society for Healthcare Epidemiology (SHEA), and an Executive Order from the President of
      the United States, recommend expansion of antimicrobial stewardship to these ambulatory care
      settings. The goal of antimicrobial stewardship is to effectively promote judicious
      antibiotic use in all healthcare settings, yet stewardship programs have not achieved their
      potential in terms of either reach or effectiveness. Reach has been limited by implementation
      mostly in inpatient settings; at the same time, recent critical experiments in behavioral
      science suggest that the effectiveness of existing stewardship programs could be greatly
      augmented through inclusion of behavioral nudges, benchmarked audit and feedback, and
      peer-to-peer comparisons.
In this proposed acute care project, the investigators will compare a package consisting of
      education for providers using existing materials from Center for Disease Control and
      Prevention's (CDC) GetSmart campaign adapted for the acute care setting led by a physician
      champion at each site (the adapted intervention), to a more intensive intervention that
      incorporates adapted GetSmart materials enhanced with individualized audit and feedback, peer
      comparisons, and behavioral nudges (the enhanced intervention). The comparative effectiveness
      of the enhanced intervention will be evaluated in a multicenter cluster randomized trial
      nested within a quasi-experimental study of acute care stewardship. The investigators'
      hypothesis is that both interventions will reduce inappropriate antibiotic prescribing for
      antibiotic nonresponsive acute respiratory infections (ARIs) in emergency departments and
      urgent care centers, but that the enhanced one will be more effective. The investigators will
      use an interrupted time series study design to measure the impact of their interventions
      against the baseline period of usual care as well as against seasonally-adjusted historical
      controls. The cluster randomized design for the two types of acute care stewardship
      interventions will allow measurement of the difference- in-differences in antibiotic
      prescribing rates for acute bronchitis, acute bronchiolitis, viral pharyngitis, influenza,
      and nonspecific upper respiratory infection (URI). Translation of proven behavioral
      techniques is a new and innovative approach to improving prescribing decisions. This project
      will expand stewardship to a new setting using innovative and effective approaches including
      the adaptation of behavioral techniques for emergency department (ED) and urgent care
      settings. The investigators will also further establish their research group as a network for
      developing novel tools, measuring outcomes for antimicrobial stewardship, and disseminating
      research findings through acute care setting-specific toolkits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Antibiotic Prescribing Trends
time frame: Up to 2 years
description: The investigators will measure the likelihood that an antibiotic is prescribed in an antibiotic-nonresponsive acute respiratory infection visit.
arm group label: Adapted Intervention
arm group type: No Intervention
description: The investigators will use GetSmart materials published by the CDC appropriate to the emergency department and urgent care settings and select and adapt brochures and other campaign messages for acute care providers.
arm group label: Enhanced Intervention
arm group type: Experimental
description: The investigators will use all of the methods of the Adapted Intervention. In addition to these methods, the investigators will add posters within exam rooms which will include modified GetSmart content and other nudges such as physician pictures with their signed public commitment to antibiotic stewardship or flair denoting commitment to stewardship. The investigators will also provide physicians with personalized monthly performance ranking with each physician receiving the designation of "top performer" or "not a top performer" based on their appropriate antibiotic prescribing practices for acute respiratory infections. This will be the Enhanced Antimicrobial Stewardship Commitment and Feedback intervention.
intervention type: Behavioral
intervention name: Enhanced Antimicrobial Stewardship Commitment and Feedback
description: Goes beyond the GetSmart recommendations to discern whether these recommendations can be improved upon.
arm group label: Enhanced Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Larissa S May, MD,MSPH,MSHS
role: Principal Investigator
affiliation: Associate Professor and Director of Emergency Department Antibiotic Stewardship
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Emergencies
mesh term: Anti-Infective Agents
mesh term: Anti-Bacterial Agents
sharing ipd: No
ipd description: No IPD planned.