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/NCT06008314</url>
    </required_header>
    <id_info>
      <org_study_id>1052404</org_study_id>
      <nct_id>NCT06008314</nct_id>
    </id_info>
    <brief_title>Pilot Deployment of ePNa Into Epic EHR</brief_title>
    <acronym>ePNa-Epic</acronym>
    <official_title>Development of &quot;SMART on FHIR (Fast Healthcare Interoperability Resources)&quot; Interoperable Clinical Decision Support (CDS) for Emergency Department (ED) Patients With Pneumonia &amp; Pilot Deployment Into Novel Epic Electronic Health Record (EHR) Environments</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nathan Dean</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>Vanderbilt University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Intermountain Health Care, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Intermountain Health has developed a electronic decision support tool to help doctors provide&#xD;
        the best care for pneumonia. The purpose of this study is to enhance the existing tool&#xD;
        (called ePneumonia (electronic Pneumonia) or ePNa) so that it can be used at other&#xD;
        institutions, and to test deployment of the tool at another institution's hospitals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study as funded by the AHRQ (Agency for Healthcare Research and Quality) involves making&#xD;
        the current ePNa system a &quot;SMART on FHIR&quot; compatible application that will enable the same&#xD;
        core software and processes to work across the Cerner and Epic electronic health record&#xD;
        platforms. The investigators will then engage with emergency department providers and&#xD;
        patients to improve user centered design, considering clinician preferences and feedback for&#xD;
        use as well as patient needs for information. Finally, the investigators will evaluate the&#xD;
        feasibility and acceptability via a pilot implementation trial of the interoperable ePNa&#xD;
        platform at two Vanderbilt affiliated hospitals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>14-day hospital-free days</measure>
      <time_frame>14 days after initial presentation to the emergency department</time_frame>
      <description>14-day hospital-free days (a metric which captures outpatient disposition from the emergency department, secondary hospital admission, and length of stay)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>30-day all-cause mortality</measure>
      <time_frame>At 30 days after initial ED presentation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ED length of stay (hours)</measure>
      <time_frame>At ED discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU length of stay (days)</measure>
      <time_frame>At ICU discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours</measure>
      <time_frame>At 72 hours after inpatient admission</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from ED presentation to first antibiotic dose (minutes)</measure>
      <time_frame>At time of first antibiotic dose</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">6917</enrollment>
    <condition>Pneumonia</condition>
    <arm_group>
      <arm_group_label>Implementation at Vanderbilt University Medical Center (VUMC) &amp; Vanderbilt Wilson County Hospital</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ePNa (the decision support tool) will be implemented at 2 EDs that are part of the Vanderbilt Health system.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>ePNa</intervention_name>
      <description>Real-time, automated clinical decision support tool for pneumonia (called &quot;ePNa&quot;)</description>
      <arm_group_label>Implementation at Vanderbilt University Medical Center (VUMC) &amp; Vanderbilt Wilson County Hospital</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For the baseline database and assessment of clinical outcomes, all data will be pulled from&#xD;
          the Epic Clarity data warehouse.&#xD;
  &#xD;
            -  2500 patients that presented to the Vanderbilt and Wilson county EDs who are &gt;= 18&#xD;
               years old will be identified by ICD-10 codes for pneumonia or acute respiratory&#xD;
               failure or sepsis with secondary pneumonia codes for the baseline database.&#xD;
  &#xD;
            -  An additional 2500 patients that presented to the Vanderbilt and Wilson county EDs who&#xD;
               are &gt;= 18 years old will be identified by having had conventional PA (posteroanterior)&#xD;
               and lateral or portable CXRs (chest X-rays), independent of ICD-10 codes.&#xD;
  &#xD;
            -  During the one year pilot trial, patients seen in the 2 EDs, who are &gt;= 18 years old&#xD;
               will be identified by ICD(International Classification of Diseases)-10 codes for&#xD;
               pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes&#xD;
               (estimated to comprise 1800 patients).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          For all above patients:&#xD;
  &#xD;
            1. Patients seen with a history of recent trauma.&#xD;
  &#xD;
            2. Subsequent episodes of pneumonia from the same patient within the study period.&#xD;
  &#xD;
            3. Patients directly admitted to hospice/comfort care.&#xD;
  &#xD;
            4. Patients admitted to a non-study hospital for further care.&#xD;
  &#xD;
            5. Patients transferred from outside hospitals.&#xD;
  &#xD;
          For the groups selected by ICD-10 pneumonia codes, an additional exclusion is:&#xD;
  &#xD;
          • Patients without radiographic evidence of pneumonia or with clear radiographic evidence&#xD;
          for an alternative diagnosis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nathan Dean, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Intermountain Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Valerie Aston, MBA</last_name>
      <phone>801-507-4606</phone>
      <email>Valerie.Aston@imail.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>David Tomer, MS</last_name>
      <phone>801-507-4694</phone>
      <email>David.Tomer@imail.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Intermountain Health Care, Inc.</investigator_affiliation>
      <investigator_full_name>Nathan Dean</investigator_full_name>
      <investigator_title>Professor, Pulmonary and Critical Care Medicine</investigator_title>
    </responsible_party>
    <keyword>Decision Support</keyword>
    <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>
    <!-- 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/NCT06008314
  org study id: 1052404
  nct id: NCT06008314
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Intermountain Health has developed a electronic decision support tool to help doctors provide
        the best care for pneumonia. The purpose of this study is to enhance the existing tool
        (called ePneumonia (electronic Pneumonia) or ePNa) so that it can be used at other
        institutions, and to test deployment of the tool at another institution's hospitals.
  This study as funded by the AHRQ (Agency for Healthcare Research and Quality) involves making
        the current ePNa system a "SMART on FHIR" compatible application that will enable the same
        core software and processes to work across the Cerner and Epic electronic health record
        platforms. The investigators will then engage with emergency department providers and
        patients to improve user centered design, considering clinician preferences and feedback for
        use as well as patient needs for information. Finally, the investigators will evaluate the
        feasibility and acceptability via a pilot implementation trial of the interoperable ePNa
        platform at two Vanderbilt affiliated hospitals.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 14-day hospital-free days
  time frame: 14 days after initial presentation to the emergency department
  description: 14-day hospital-free days (a metric which captures outpatient disposition from the emergency department, secondary hospital admission, and length of stay)
  measure: 30-day all-cause mortality
  time frame: At 30 days after initial ED presentation
  measure: ED length of stay (hours)
  time frame: At ED discharge
  measure: ICU length of stay (days)
  time frame: At ICU discharge
  measure: Number of patients admitted to floor who are subsequently transferred to ICU within 72 hours
  time frame: At 72 hours after inpatient admission
  measure: Time from ED presentation to first antibiotic dose (minutes)
  time frame: At time of first antibiotic dose
  arm group label: Implementation at Vanderbilt University Medical Center (VUMC) & Vanderbilt Wilson County Hospital
  arm group type: Experimental
  description: ePNa (the decision support tool) will be implemented at 2 EDs that are part of the Vanderbilt Health system.
  intervention type: Other
  intervention name: ePNa
  description: Real-time, automated clinical decision support tool for pneumonia (called "ePNa")
  arm group label: Implementation at Vanderbilt University Medical Center (VUMC) & Vanderbilt Wilson County Hospital
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nathan Dean, MD
  role: Principal Investigator
  affiliation: Intermountain Health
  last name: Valerie Aston, MBA
  phone: 801-507-4606
  email: Valerie.Aston@imail.org
  last name: David Tomer, MS
  phone: 801-507-4694
  email: David.Tomer@imail.org
  responsible party type: Sponsor-Investigator
  investigator affiliation: Intermountain Health Care, Inc.
  investigator full name: Nathan Dean
  investigator title: Professor, Pulmonary and Critical Care Medicine
  mesh term: Pneumonia
  sharing ipd: No