<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/NCT03760419</url>
  </required_header>
  <id_info>
    <org_study_id>R01AI125642</org_study_id>
    <secondary_id>R01AI125642</secondary_id>
    <nct_id>NCT03760419</nct_id>
  </id_info>
  <brief_title>Improving CarE for Community Acquired Pneumonia 1</brief_title>
  <acronym>ICE-CAP1</acronym>
  <official_title>Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Antibiotic Decision Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      Children with pneumonia presenting to the emergency department at Monroe Carell Jr.&#xD;
      Children's Hospital at Vanderbilt or Children's Hospital of Pittsburgh will be potentially&#xD;
      eligible for study. During intervention periods, providers caring for enrolled children will&#xD;
      be presented with a detailed decision support strategy that emphasizes management in&#xD;
      accordance with national guideline recommendations. The anticipated study duration is 18&#xD;
      months and, as this study does not include direct contact with enrolled subjects, there is no&#xD;
      anticipated follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pneumonia is the most common serious infection in childhood. In the United States (US),&#xD;
      pneumonia accounts for 1-4% of all emergency department (ED) visits in children (3-28 per&#xD;
      1,000 US children per year) and ranks among the top 3 reasons for pediatric hospitalization&#xD;
      with &gt;100,000 hospitalizations per year (15-22 per 100,000 US children per year)2-5.&#xD;
      Pneumonia also accounts for more days of antibiotic use in US children's hospitals than any&#xD;
      other condition.&#xD;
&#xD;
      Safely reducing inappropriate antibiotic use is critical to slow the progression of&#xD;
      antimicrobial resistance, and childhood pneumonia is a key area where substantial&#xD;
      improvements can be made. In the 2011 Pediatric Infectious Diseases Society/Infectious&#xD;
      Diseases Society of America (PIDS/IDSA) pneumonia guideline, appropriate use of antibiotics&#xD;
      was an important area of emphasis. For presumed bacterial pneumonia, recommendations&#xD;
      emphasize the use of a single, narrow-spectrum antibiotic (i.e. amoxicillin or ampicillin).&#xD;
      In children &lt;6 years of age treated in the outpatient setting, the guideline recommended&#xD;
      considering withholding antibiotics, recognizing that pneumonia in this population is most&#xD;
      often caused by viruses. Both of these recommendations were graded as strong and supported by&#xD;
      high-quality evidence. Nonetheless, in a large database study we conducted just prior to&#xD;
      release of the 2011 guideline, use of broad-spectrum antibiotics was very common among&#xD;
      children hospitalized with pneumonia, with substantial differences in antibiotic selection&#xD;
      patterns among the various hospitals. In that study, use of narrow-spectrum ampicillin was&#xD;
      rare (&lt;5%). High rates of broad-spectrum antibiotic use were also noted in a study of&#xD;
      children with pneumonia treated and released from US EDs, with &lt;30% of children receiving&#xD;
      narrow-spectrum therapy.&#xD;
&#xD;
      Study Aim: To test the hypothesis that electronic antibiotic decision support increases&#xD;
      guideline-concordant antibiotic use compared with usual care in the emergency department.&#xD;
&#xD;
      The primary outcome is the proportion of children exclusively receiving guideline-concordant&#xD;
      first line antibiotic therapy during the first 24 hours of care. Secondary outcomes include&#xD;
      exclusive use of concordant antibiotic therapy for the entire episode, any use of concordant&#xD;
      antibiotic therapy during the first 24 hours of care and for the entire episode, and&#xD;
      emergency department revisits and hospitalizations within 72 hours and 7 days of the index&#xD;
      discharge.&#xD;
&#xD;
      In this study, conducted at two experienced academic centers, the investigator will implement&#xD;
      and evaluate an electronic health record based clinical decision support application to&#xD;
      promote antibiotic use in concordance with the 2011 PIDS/IDSA guideline in a pragmatic,&#xD;
      cluster randomized trial. Decisions regarding management, including antibiotic selection and&#xD;
      site of care, will be at the discretion of the treating provider and will not be restricted&#xD;
      or altered in any way. Thus, this study poses no greater than minimal risks to participants.&#xD;
      Due to the nature of the research, waiver of informed consent has been provided, as it has&#xD;
      been done in similar pragmatic studies at the institutions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 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>Effectiveness of the EHR-based antibiotic decision support application for promoting guideline-concordant antibiotic prescribing in children presenting for emergency care will be evaluated in a pragmatic, cluster-randomized study conducted over a period of 18 months that includes two respiratory seasons. Randomization will occur monthly at each hospital. To ensure balanced representation of each arm in periods of both low and high pneumonia prevalence, randomization will occur in 3 permuted blocks (size=6).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours</measure>
    <time_frame>18 months</time_frame>
    <description>The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode</measure>
    <time_frame>18 months</time_frame>
    <description>This secondary outcome reports encounters in which established antibiotic stewardship guidelines are followed for ALL prescribing for the duration of the encounter (ED triage through hospital discharge).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours</measure>
    <time_frame>18 months</time_frame>
    <description>This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any Guideline-Concordant Antibiotic Prescribing, Entire Episode</measure>
    <time_frame>18 months</time_frame>
    <description>This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1027</enrollment>
  <condition>Pneumonia Childhood</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The antibiotic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Clinical Decision Support</intervention_name>
    <description>For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Six months to &lt;18 years of age&#xD;
&#xD;
          -  Radiographic evidence of pneumonia in ED&#xD;
&#xD;
          -  Provider-confirmed diagnosis of pneumonia (via Clinical Decision Support [CDS])&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with tracheostomy, cystic fibrosis, immunosuppression&#xD;
&#xD;
          -  Inter-hospital transfers&#xD;
&#xD;
          -  Hospitalization within preceding 7 days&#xD;
&#xD;
          -  Previously enrolled within preceding 28 days&#xD;
&#xD;
          -  Provider preference for any reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek J Williams, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>August 11, 2022</results_first_submitted>
  <results_first_submitted_qc>November 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 8, 2022</results_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Derek Williams</investigator_full_name>
    <investigator_title>Derek Williams, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03760419/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03760419/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Monroe Carell Jr Children's Hospital at Vanderbilt</title>
          <description>Children with pneumonia presenting to the ED at Monroe Carell Jr. Children's Hospital at Vanderbilt. Encounters were randomized to control or intervention.&#xD;
Control: Standard of care will be provided to those randomized to the control arm.&#xD;
Intervention: The antibiotic decision support application will be provided to those randomized to the intervention arm.</description>
        </group>
        <group group_id="P2">
          <title>Children's Hospital of Pittsburgh</title>
          <description>Children with pneumonia presenting to the ED at Monroe Carell Jr. Children's Hospital at Vanderbilt. Encounters were randomized to control or intervention.&#xD;
Control: Standard of care will be provided to those randomized to the control arm.&#xD;
Intervention: The antibiotic decision support application will be provided to those randomized to the intervention arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="535"/>
                <participants group_id="P2" count="492"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Intervention</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="335"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Contol</title>
              <participants_list>
                <participants group_id="P1" count="321"/>
                <participants group_id="P2" count="157"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="535"/>
                <participants group_id="P2" count="492"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Arm</title>
          <description>No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.</description>
        </group>
        <group group_id="B2">
          <title>Intervention Arm</title>
          <description>The antibiotic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.&#xD;
Clinical Decision Support: For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="478"/>
            <count group_id="B2" value="549"/>
            <count group_id="B3" value="1027"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.8" lower_limit="2.2" upper_limit="9.5"/>
                    <measurement group_id="B2" value="4.0" lower_limit="1.7" upper_limit="7.4"/>
                    <measurement group_id="B3" value="4.2" lower_limit="1.9" upper_limit="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="246"/>
                    <measurement group_id="B3" value="463"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="261"/>
                    <measurement group_id="B2" value="303"/>
                    <measurement group_id="B3" value="564"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="390"/>
                    <measurement group_id="B2" value="472"/>
                    <measurement group_id="B3" value="862"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="294"/>
                    <measurement group_id="B2" value="399"/>
                    <measurement group_id="B3" value="693"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Non-Chronic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="282"/>
                    <measurement group_id="B2" value="359"/>
                    <measurement group_id="B3" value="641"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-complex Chronic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Complex Chronic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance</title>
          <population>This measurement was not able to be assessed for 3 patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="475"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1024"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Public</title>
                  <measurement_list>
                    <measurement group_id="B1" value="281"/>
                    <measurement group_id="B2" value="280"/>
                    <measurement group_id="B3" value="561"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Private</title>
                  <measurement_list>
                    <measurement group_id="B1" value="176"/>
                    <measurement group_id="B2" value="246"/>
                    <measurement group_id="B3" value="422"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Self-Pay</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Temperature</title>
          <units>degrees Celsius</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.3" lower_limit="36.8" upper_limit="38.1"/>
                    <measurement group_id="B2" value="37.5" lower_limit="36.9" upper_limit="38.4"/>
                    <measurement group_id="B3" value="37.4" lower_limit="36.9" upper_limit="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart rate</title>
          <units>bpm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="134" lower_limit="113" upper_limit="153"/>
                    <measurement group_id="B2" value="139" lower_limit="120" upper_limit="159"/>
                    <measurement group_id="B3" value="136" lower_limit="116" upper_limit="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respiratory rate</title>
          <description>BPM (breaths/min)</description>
          <units>respirations per minute</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" lower_limit="24" upper_limit="40"/>
                    <measurement group_id="B2" value="34" lower_limit="24" upper_limit="46"/>
                    <measurement group_id="B3" value="32" lower_limit="24" upper_limit="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic BP</title>
          <units>mmHg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108" lower_limit="100" upper_limit="117"/>
                    <measurement group_id="B2" value="108" lower_limit="100" upper_limit="116"/>
                    <measurement group_id="B3" value="108" lower_limit="100" upper_limit="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SpO2:FiO2 ratio</title>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="462" lower_limit="360" upper_limit="479"/>
                    <measurement group_id="B2" value="457" lower_limit="306" upper_limit="474"/>
                    <measurement group_id="B3" value="457" lower_limit="328" upper_limit="474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ED Disposition</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Home</title>
                  <measurement_list>
                    <measurement group_id="B1" value="212"/>
                    <measurement group_id="B2" value="219"/>
                    <measurement group_id="B3" value="431"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Inpatient</title>
                  <measurement_list>
                    <measurement group_id="B1" value="189"/>
                    <measurement group_id="B2" value="215"/>
                    <measurement group_id="B3" value="404"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Intensive Care</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Enrolling Site</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="478"/>
                    <count group_id="B2" value="549"/>
                    <count group_id="B3" value="1027"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Site A</title>
                  <measurement_list>
                    <measurement group_id="B1" value="321"/>
                    <measurement group_id="B2" value="214"/>
                    <measurement group_id="B3" value="535"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Site B</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="335"/>
                    <measurement group_id="B3" value="492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours</title>
        <description>The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.</description>
        <time_frame>18 months</time_frame>
        <population>All categories except &quot;Overall&quot; are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Arm</title>
            <description>No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.</description>
          </group>
          <group group_id="O2">
            <title>Intervention Arm</title>
            <description>The antibiotic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.&#xD;
Clinical Decision Support: For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.</description>
          </group>
        </group_list>
        <measure>
          <title>Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours</title>
          <description>The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.</description>
          <population>All categories except &quot;Overall&quot; are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="478"/>
                <count group_id="O2" value="549"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="478"/>
                    <count group_id="O2" value="549"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="255"/>
                    <measurement group_id="O2" value="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="321"/>
                    <count group_id="O2" value="214"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174"/>
                    <measurement group_id="O2" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="335"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Outpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="219"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="215"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &lt; 6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163"/>
                    <measurement group_id="O2" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;/= 6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="198"/>
                    <count group_id="O2" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Receiving Antibiotics</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="370"/>
                    <count group_id="O2" value="455"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147"/>
                    <measurement group_id="O2" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode</title>
        <description>This secondary outcome reports encounters in which established antibiotic stewardship guidelines are followed for ALL prescribing for the duration of the encounter (ED triage through hospital discharge).</description>
        <time_frame>18 months</time_frame>
        <population>All categories except &quot;Overall&quot; are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Arm</title>
            <description>No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.</description>
          </group>
          <group group_id="O2">
            <title>Intervention Arm</title>
            <description>The antibiotic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.&#xD;
Clinical Decision Support: For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.</description>
          </group>
        </group_list>
        <measure>
          <title>Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode</title>
          <description>This secondary outcome reports encounters in which established antibiotic stewardship guidelines are followed for ALL prescribing for the duration of the encounter (ED triage through hospital discharge).</description>
          <population>All categories except &quot;Overall&quot; are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="478"/>
                <count group_id="O2" value="549"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="478"/>
                    <count group_id="O2" value="549"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240"/>
                    <measurement group_id="O2" value="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="321"/>
                    <count group_id="O2" value="214"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163"/>
                    <measurement group_id="O2" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="335"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Outpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="219"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="215"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &lt;6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156"/>
                    <measurement group_id="O2" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;/= 6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="198"/>
                    <count group_id="O2" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Receiving Antibiotics</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="373"/>
                    <count group_id="O2" value="462"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours</title>
        <description>This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.</description>
        <time_frame>18 months</time_frame>
        <population>All categories except &quot;Overall&quot; are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Arm</title>
            <description>No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.</description>
          </group>
          <group group_id="O2">
            <title>Intervention Arm</title>
            <description>The antibiotic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.&#xD;
Clinical Decision Support: For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.</description>
          </group>
        </group_list>
        <measure>
          <title>Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours</title>
          <description>This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.</description>
          <population>All categories except &quot;Overall&quot; are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="478"/>
                <count group_id="O2" value="549"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="478"/>
                    <count group_id="O2" value="549"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="297"/>
                    <measurement group_id="O2" value="358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="321"/>
                    <count group_id="O2" value="214"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198"/>
                    <measurement group_id="O2" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="335"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Outpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="219"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                    <measurement group_id="O2" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="215"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &lt;6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189"/>
                    <measurement group_id="O2" value="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;/= 6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="198"/>
                    <count group_id="O2" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Receiving Antibiotics</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="370"/>
                    <count group_id="O2" value="455"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189"/>
                    <measurement group_id="O2" value="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Any Guideline-Concordant Antibiotic Prescribing, Entire Episode</title>
        <description>This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).</description>
        <time_frame>18 months</time_frame>
        <population>All categories except &quot;Overall&quot; are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Arm</title>
            <description>No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.</description>
          </group>
          <group group_id="O2">
            <title>Intervention Arm</title>
            <description>The antibiotic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.&#xD;
Clinical Decision Support: For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.</description>
          </group>
        </group_list>
        <measure>
          <title>Any Guideline-Concordant Antibiotic Prescribing, Entire Episode</title>
          <description>This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).</description>
          <population>All categories except &quot;Overall&quot; are subsets of the overall number. The category for each row shows the percentage of that subset that meets the specific criteria.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="478"/>
                <count group_id="O2" value="549"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="478"/>
                    <count group_id="O2" value="549"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305"/>
                    <measurement group_id="O2" value="383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="321"/>
                    <count group_id="O2" value="214"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200"/>
                    <measurement group_id="O2" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Site B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="335"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Outpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="219"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                    <measurement group_id="O2" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inpatient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="189"/>
                    <count group_id="O2" value="215"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &lt;6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="359"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="195"/>
                    <measurement group_id="O2" value="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;/= 6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="198"/>
                    <count group_id="O2" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Receiving Antibiotics</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="373"/>
                    <count group_id="O2" value="462"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200"/>
                    <measurement group_id="O2" value="297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18 months</time_frame>
      <desc>Adverse event reporting will focus exclusively on ED revisits and/or inpatient hospital re-admissions within 3- or 7-days from index discharge and death within 30 days of index discharge. Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Arm</title>
          <description>No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.</description>
        </group>
        <group group_id="E2">
          <title>Intervention Arm</title>
          <description>The antibiotic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.&#xD;
Clinical Decision Support: For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="478"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="549"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="478"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="549"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ED revisit within 72 hours</sub_title>
                <description>Patient returns to the Emergency Department within 72 hours for same illness as index visit.</description>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="478"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="549"/>
              </event>
              <event>
                <sub_title>ED revisit within 7 days</sub_title>
                <description>Patient returns to the Emergency Department within 7 days for same illness as index visit.</description>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="478"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="549"/>
              </event>
              <event>
                <sub_title>Re-hospitalization within 72 hours</sub_title>
                <description>Patient is admitted to the hospital within 72 hours for same illness as index visit.</description>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="478"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="549"/>
              </event>
              <event>
                <sub_title>Re-hospitalization within 7 days</sub_title>
                <description>Patient is admitted to the hospital within 7 days for same illness as index visit.</description>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="478"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="549"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="478"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="549"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Derek J. Williams, MD, MPH</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>615-322-2744</phone>
      <email>derek.williams@vumc.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03760419
org study id: R01AI125642
secondary id: R01AI125642
nct id: NCT03760419
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Children with pneumonia presenting to the emergency department at Monroe Carell Jr.
      Children's Hospital at Vanderbilt or Children's Hospital of Pittsburgh will be potentially
      eligible for study. During intervention periods, providers caring for enrolled children will
      be presented with a detailed decision support strategy that emphasizes management in
      accordance with national guideline recommendations. The anticipated study duration is 18
      months and, as this study does not include direct contact with enrolled subjects, there is no
      anticipated follow up.
Pneumonia is the most common serious infection in childhood. In the United States (US),
      pneumonia accounts for 1-4% of all emergency department (ED) visits in children (3-28 per
      1,000 US children per year) and ranks among the top 3 reasons for pediatric hospitalization
      with >100,000 hospitalizations per year (15-22 per 100,000 US children per year)2-5.
      Pneumonia also accounts for more days of antibiotic use in US children's hospitals than any
      other condition.

      Safely reducing inappropriate antibiotic use is critical to slow the progression of
      antimicrobial resistance, and childhood pneumonia is a key area where substantial
      improvements can be made. In the 2011 Pediatric Infectious Diseases Society/Infectious
      Diseases Society of America (PIDS/IDSA) pneumonia guideline, appropriate use of antibiotics
      was an important area of emphasis. For presumed bacterial pneumonia, recommendations
      emphasize the use of a single, narrow-spectrum antibiotic (i.e. amoxicillin or ampicillin).
      In children <6 years of age treated in the outpatient setting, the guideline recommended
      considering withholding antibiotics, recognizing that pneumonia in this population is most
      often caused by viruses. Both of these recommendations were graded as strong and supported by
      high-quality evidence. Nonetheless, in a large database study we conducted just prior to
      release of the 2011 guideline, use of broad-spectrum antibiotics was very common among
      children hospitalized with pneumonia, with substantial differences in antibiotic selection
      patterns among the various hospitals. In that study, use of narrow-spectrum ampicillin was
      rare (<5%). High rates of broad-spectrum antibiotic use were also noted in a study of
      children with pneumonia treated and released from US EDs, with <30% of children receiving
      narrow-spectrum therapy.

      Study Aim: To test the hypothesis that electronic antibiotic decision support increases
      guideline-concordant antibiotic use compared with usual care in the emergency department.

      The primary outcome is the proportion of children exclusively receiving guideline-concordant
      first line antibiotic therapy during the first 24 hours of care. Secondary outcomes include
      exclusive use of concordant antibiotic therapy for the entire episode, any use of concordant
      antibiotic therapy during the first 24 hours of care and for the entire episode, and
      emergency department revisits and hospitalizations within 72 hours and 7 days of the index
      discharge.

      In this study, conducted at two experienced academic centers, the investigator will implement
      and evaluate an electronic health record based clinical decision support application to
      promote antibiotic use in concordance with the 2011 PIDS/IDSA guideline in a pragmatic,
      cluster randomized trial. Decisions regarding management, including antibiotic selection and
      site of care, will be at the discretion of the treating provider and will not be restricted
      or altered in any way. Thus, this study poses no greater than minimal risks to participants.
      Due to the nature of the research, waiver of informed consent has been provided, as it has
      been done in similar pragmatic studies at the institutions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Effectiveness of the EHR-based antibiotic decision support application for promoting guideline-concordant antibiotic prescribing in children presenting for emergency care will be evaluated in a pragmatic, cluster-randomized study conducted over a period of 18 months that includes two respiratory seasons. Randomization will occur monthly at each hospital. To ensure balanced representation of each arm in periods of both low and high pneumonia prevalence, randomization will occur in 3 permuted blocks (size=6).
primary purpose: Health Services Research
masking: None (Open Label)
measure: Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours
time frame: 18 months
description: The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.
measure: Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode
time frame: 18 months
description: This secondary outcome reports encounters in which established antibiotic stewardship guidelines are followed for ALL prescribing for the duration of the encounter (ED triage through hospital discharge).
measure: Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours
time frame: 18 months
description: This secondary outcome includes ANY guideline-concordant prescribing during the first 24 hours of the encounter.
measure: Any Guideline-Concordant Antibiotic Prescribing, Entire Episode
time frame: 18 months
description: This secondary outcome includes ANY guideline-concordant prescribing during the ENTIRE encounter (ED triage through hospital discharge).
arm group label: Intervention Arm
arm group type: Experimental
description: The antibiotic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.
arm group label: Control Arm
arm group type: No Intervention
description: No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.
intervention type: Behavioral
intervention name: Clinical Decision Support
description: For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Years
healthy volunteers: No
last name: Derek J Williams, MD, MPH
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Derek Williams
investigator title: Derek Williams, Principal Investigator
mesh term: Pneumonia
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 