xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06033079</url>
    </required_header>
    <id_info>
      <org_study_id>R01AI125642pt2</org_study_id>
      <secondary_id>R01AI125642</secondary_id>
      <nct_id>NCT06033079</nct_id>
    </id_info>
    <brief_title>Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2)</brief_title>
    <acronym>ICE-CAP2</acronym>
    <official_title>Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Prognostic 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 24&#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). Pneumonia&#xD;
        also accounts for more days of antibiotic use in US children's hospitals than any other&#xD;
        condition.&#xD;
  &#xD;
        Emergency care for childhood pneumonia, including hospitalization rates, varies widely across&#xD;
        the nation. A study examining hospital admission rates at 35 US children's hospitals from&#xD;
        2009-12 showed marked differences in severity-adjusted pneumonia hospital admission rates&#xD;
        (median 31%; range 19-69%). Provider preferences and inaccurate risk perceptions contribute&#xD;
        to these differences in hospitalization rates. Within the Intermountain Healthcare System in&#xD;
        Utah, Dean et al. exposed large differences in admission rates (range 38-79%) among 18&#xD;
        individual ED providers providing care for &gt;2,000 adults with pneumonia. Differences were not&#xD;
        explained by patient characteristics or illness severity and higher rates of hospitalization&#xD;
        did not reduce hospital readmissions or mortality. In another multicenter study of 472 adults&#xD;
        with pneumonia at &lt;4% risk of 30-day mortality estimated using objective severity scores,&#xD;
        providers overestimated the risk of mortality in 5% of outpatients (range across institutions&#xD;
        0-12%) and 41% of inpatients (range across institutions 36-48%). These studies suggest that&#xD;
        risk perceptions are often inaccurate, and potentially lead to unnecessary or prolonged&#xD;
        hospitalizations and intensive therapies. Similar studies have not been performed in children&#xD;
        because no valid prognostic tools exist to reliably predict pediatric pneumonia severity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 20, 2020</start_date>
    <completion_date type="Actual">November 30, 2022</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</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>We will conduct a randomized controlled trial comparing our prognostic tool (intervention arm) to usual care (control arm) over a period of 24 months. Randomization will occur at the patient level. Allocation to intervention or control will be based on medical record number (even vs. odd) or similar strategy and will be assigned automatically once a provider confirms the diagnosis of pneumonia. Importantly, all standard of care treatment options will be available and decision-making will not be restricted in any way in either group.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants disposed to appropriate site of care</measure>
      <time_frame>24 months</time_frame>
      <description>Number of participants who were disposed to the appropriate site of care according to the following definitions: Discharged to home (No subsequent hospitalization within 24h); Inpatient ward (Hospital length of stay (LOS) ≥ 24h OR hospital LOS &lt; 24h but objective criteria for admission present (eg, need for supplemental oxygen)) AND no subsequent transfer to ICU within 24h; or ICU (ICU LOS ≥ 24h OR ICU LOS &lt; 24h but objective criteria for ICU admission present (eg, respiratory failure))</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall site-of-care disposition</measure>
      <time_frame>24 months</time_frame>
      <description>This secondary outcome reports the total number of participants who were discharged from the ED, admitted to the inpatient ward, and admitted to the ICU.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ED revisits (72 hours)</measure>
      <time_frame>24 months</time_frame>
      <description>This secondary outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ED revisits (7 days)</measure>
      <time_frame>24 months</time_frame>
      <description>This secondary outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rehospitalizations (72 hours)</measure>
      <time_frame>24 months</time_frame>
      <description>This secondary outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 72 hours of the index discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rehospitalizations (7 days)</measure>
      <time_frame>24 months</time_frame>
      <description>This secondary outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 7 days of the index discharge.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">536</enrollment>
    <condition>Pneumonia Childhood</condition>
    <arm_group>
      <arm_group_label>CDS Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The prognostic 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_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 prognostic information derived using our previously validated and best performing model. The decision support application will automatically calculate predicted risk for moderate (intensive care) and severe (respiratory failure or shock) outcomes using the parameters derived from the prognostic tool's regression equation. Outcome probabilities will be integrated into the decision support application and displayed within the EHR.</description>
      <arm_group_label>CDS Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Six months to &lt;18 years of age&#xD;
  &#xD;
            2. Radiographic evidence of pneumonia in ED&#xD;
  &#xD;
            3. Provider-confirmed diagnosis of pneumonia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Children with tracheostomy, cystic fibrosis, immunosuppression&#xD;
  &#xD;
            2. Inter-hospital transfers&#xD;
  &#xD;
            3. Hospitalization within preceding 7 days&#xD;
  &#xD;
            4. Previously enrolled within preceding 28 days&#xD;
  &#xD;
            5. 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>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Associate Professor of Pediatrics</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>October 26, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT06033079/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>October 26, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT06033079/SAP_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06033079
  org study id: R01AI125642pt2
  secondary id: R01AI125642
  nct id: NCT06033079
  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 24
        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). Pneumonia
        also accounts for more days of antibiotic use in US children's hospitals than any other
        condition.
  
        Emergency care for childhood pneumonia, including hospitalization rates, varies widely across
        the nation. A study examining hospital admission rates at 35 US children's hospitals from
        2009-12 showed marked differences in severity-adjusted pneumonia hospital admission rates
        (median 31%; range 19-69%). Provider preferences and inaccurate risk perceptions contribute
        to these differences in hospitalization rates. Within the Intermountain Healthcare System in
        Utah, Dean et al. exposed large differences in admission rates (range 38-79%) among 18
        individual ED providers providing care for >2,000 adults with pneumonia. Differences were not
        explained by patient characteristics or illness severity and higher rates of hospitalization
        did not reduce hospital readmissions or mortality. In another multicenter study of 472 adults
        with pneumonia at <4% risk of 30-day mortality estimated using objective severity scores,
        providers overestimated the risk of mortality in 5% of outpatients (range across institutions
        0-12%) and 41% of inpatients (range across institutions 36-48%). These studies suggest that
        risk perceptions are often inaccurate, and potentially lead to unnecessary or prolonged
        hospitalizations and intensive therapies. Similar studies have not been performed in children
        because no valid prognostic tools exist to reliably predict pediatric pneumonia severity.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: We will conduct a randomized controlled trial comparing our prognostic tool (intervention arm) to usual care (control arm) over a period of 24 months. Randomization will occur at the patient level. Allocation to intervention or control will be based on medical record number (even vs. odd) or similar strategy and will be assigned automatically once a provider confirms the diagnosis of pneumonia. Importantly, all standard of care treatment options will be available and decision-making will not be restricted in any way in either group.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Number of participants disposed to appropriate site of care
  time frame: 24 months
  description: Number of participants who were disposed to the appropriate site of care according to the following definitions: Discharged to home (No subsequent hospitalization within 24h); Inpatient ward (Hospital length of stay (LOS) ≥ 24h OR hospital LOS < 24h but objective criteria for admission present (eg, need for supplemental oxygen)) AND no subsequent transfer to ICU within 24h; or ICU (ICU LOS ≥ 24h OR ICU LOS < 24h but objective criteria for ICU admission present (eg, respiratory failure))
  measure: Overall site-of-care disposition
  time frame: 24 months
  description: This secondary outcome reports the total number of participants who were discharged from the ED, admitted to the inpatient ward, and admitted to the ICU.
  measure: ED revisits (72 hours)
  time frame: 24 months
  description: This secondary outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.
  measure: ED revisits (7 days)
  time frame: 24 months
  description: This secondary outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.
  measure: Rehospitalizations (72 hours)
  time frame: 24 months
  description: This secondary outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 72 hours of the index discharge.
  measure: Rehospitalizations (7 days)
  time frame: 24 months
  description: This secondary outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 7 days of the index discharge.
  arm group label: CDS Intervention
  arm group type: Experimental
  description: The prognostic 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 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 prognostic information derived using our previously validated and best performing model. The decision support application will automatically calculate predicted risk for moderate (intensive care) and severe (respiratory failure or shock) outcomes using the parameters derived from the prognostic tool's regression equation. Outcome probabilities will be integrated into the decision support application and displayed within the EHR.
  arm group label: CDS Intervention
  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: Associate Professor of Pediatrics
  mesh term: Pneumonia
  sharing ipd: No
  provided document: 
  provided document: 