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/NCT06027593</url>
    </required_header>
    <id_info>
      <org_study_id>22-019749</org_study_id>
      <secondary_id>75D30121F00002</secondary_id>
      <secondary_id>850722</secondary_id>
      <secondary_id>851400</secondary_id>
      <nct_id>NCT06027593</nct_id>
    </id_info>
    <brief_title>Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions</brief_title>
    <acronym>EMPOWER</acronym>
    <official_title>Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital of Philadelphia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centers for Disease Control and Prevention</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Hospital of Philadelphia</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>
        The main goal of this study is to use automated electronic reports to assess and improve&#xD;
        guideline-concordant antibiotic use for:&#xD;
  &#xD;
        1) adult inpatients with community-acquired pneumonia (CAP); 2) pediatric inpatients with&#xD;
        CAP; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute&#xD;
        otitis media.&#xD;
  &#xD;
        There are two cohorts in this study: Patients with one of the aforementioned conditions who&#xD;
        meet inclusion criteria, and the clinicians providing clinical care to these patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Antibiotic stewardship (AS) has been shown to improve patient outcomes, decrease adverse&#xD;
        events, and decrease antibiotic resistance. This group of investigators previously partnered&#xD;
        with collaborators at the Centers for Disease Control and Prevention (CDC) and conducted&#xD;
        relevant pilot work in developing and validating electronic indicators of inappropriate&#xD;
        antibiotic prescribing for 8 conditions, amongst which are the four conditions of interest in&#xD;
        this study: adult inpatients with CAP; pediatric inpatients with CAP; adult outpatients with&#xD;
        acute pharyngitis; and pediatric outpatients with acute pharyngitis). Methods were developed&#xD;
        to generate automatic, routine reports to identify elements of inappropriate antibiotic use&#xD;
        including; 1) the decision to initiate antibiotic therapy; 2) the choice of antibiotic agent;&#xD;
        and 3) the duration of antibiotic use.&#xD;
  &#xD;
        The purpose of this project is to assess the impact of these developed electronic indicators&#xD;
        on supporting AS efforts to improve the appropriateness of antibiotic use, as well as the&#xD;
        acceptability and feasibility of delivering these reports to prescribers. The investigators&#xD;
        aim to:&#xD;
  &#xD;
          1. Refine and validate indicators of appropriate antibiotic use by utilizing Electronic&#xD;
             Health Record (EHR) data, including International Classification of Diseases (ICD-10)&#xD;
             codes, medications, laboratory data, comorbid medical conditions, site of care, clinical&#xD;
             documentation, prior hospitalizations, and medication exposure. The researchers will&#xD;
             validate the definitions of the various conditions and appropriateness captured&#xD;
             electronically with a manual chart review of clinical documentation.&#xD;
  &#xD;
          2. Implement a scalable and sustainable AS feedback report-based intervention for these&#xD;
             four conditions informed by a rapid user-centered design process.&#xD;
  &#xD;
          3. Track the impact of stewardship interventions and report to key stakeholders, including&#xD;
             prescribers.&#xD;
  &#xD;
          4. Create a publicly available toolkit based on the findings of this project that includes:&#xD;
             (i) analytic tools and resources for using the automated reports of key indicators to&#xD;
             target stewardship interventions and (ii) an implementation guide to inform the&#xD;
             application of automated reports to stewardship in the inpatient and outpatient&#xD;
             settings.&#xD;
  &#xD;
        If proven effective, these EHR-based approaches hold the promise to greatly enhance the&#xD;
        effectiveness and efficiency of AS initiatives.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 18, 2022</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Guideline-concordant antibiotic Use for adult pharyngitis</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Guideline-concordant antibiotic Use for pediatric acute otitis media</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Guideline-concordant antibiotic Use for CAP</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Percentage of CAP encounters with guideline-concordant antibiotic use for both the duration and choice metrics.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Guideline-concordant decision to prescribe antibiotics for adult pharyngitis</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Percentage of patients for which the decision to prescribe an antibiotic was correct.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for adult pharyngitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Guideline-concordant decision to prescribe antibiotics for pediatric acute otitis media</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Percentage of patients for which the decision to prescribe an antibiotic was correct.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Guideline-concordant decision to not prescribe antibiotics for pediatric acute otitis media</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for acute otitis media</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Guideline-concordant antibiotic choice</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Percentage of patients who received guideline-concordant antibiotic choice for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Guideline-concordant antibiotic duration</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Percentage of patients who received guideline-concordant antibiotic duration for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to the emergency department</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Percentage of patients who return to the emergency department within 14 days of discharge following hospitalization for CAP.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to the clinic</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Percentage of patients who return for an outpatient visit within 7 days of being diagnosed with adult pharyngitis or pediatric acute otitis media.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmissions within 14 days of the index visit for CAP</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Percentage of inpatients with CAP who are readmitted within 14 days of the index visit for the same or related condition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>New antibiotic prescription within 7 days of the index visit</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Percentage of patients who receive a new antibiotic prescription within 7 days of the index visit.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Measure of feasibility of intervention</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Feasibility, the extent to which the intervention can be carried out in the clinical setting, will be determined in collaboration with our local stakeholders but may include the proportion of clinicians who attend educational sessions and/or unit-based meetings during which antibiotic use data is reviewed.</description>
    </other_outcome>
    <other_outcome>
      <measure>Acceptability of intervention</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Acceptability, how well the intervention was received by the prescribing clinicians will be measured during surveys and structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">511000</enrollment>
    <condition>Community-acquired Pneumonia</condition>
    <condition>Acute Otitis Media</condition>
    <condition>Pharyngitis</condition>
    <arm_group>
      <arm_group_label>Prescribing Clinicians</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>During the pre-intervention period which will last up to approximately 24 months, investigators will retrospectively collect data on appropriate antibiotic prescribing for the conditions. In the post-intervention period of approximately 24 months, investigators will implement a provider-focused intervention, consisting of feedback reports to providers using the validated metrics of antibiotic prescribing. These measures are based on national guidelines for appropriate antibiotic prescribing. Following implementation of the intervention, the investigative team will collect the same measures.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients diagnosed with conditions of interest during study period</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Interactions between investigators and patients will be limited to review of existing EHR data. Investigators will have no direct contact with patients. The data from the University of Pennsylvania Health System (UPHS) and Children's Hospital of Philadelphia (CHOP) will be extracted from data warehouses that store data from the electronic health record. These data will be used in feedback report generation as well as in outcome assessment. An estimated total of 10,000 inpatients with CAP (adult and pediatric) will be recruited. Similarly, about 500,000 patients (adult pharyngitis and pediatric acute otitis media combined) will be recruited in the outpatient setting.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mixed methods intervention</intervention_name>
      <description>Investigators will implement the intervention at the completion of the rapid user-centered design process and consultation with CDC collaborators.&#xD;
  During the rapid user-centered design process, the team will engage key stakeholders to create and optimize feedback reports that will fit the prescribing context, and determine appropriate implementation supports that will be needed to accompany the introduction of the feedback reports to each setting.&#xD;
  Following the initial awareness-building activities, investigators will circulate the antibiotic prescribing feedback reports. After the first 3 months (approximately) of report dissemination, the team will assess the feasibility and acceptability of the reports and implementation activities by administering a brief survey to prescribers and also conducting interviews with them. No direct identifiers will be collected.</description>
      <arm_group_label>Prescribing Clinicians</arm_group_label>
      <other_name>Quasi experimental intervention</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Patient Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of one of four conditions based on ICD-10 diagnostic codes.&#xD;
  &#xD;
          Patient Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of specific complex chronic conditions&#xD;
  &#xD;
            -  Use of immunocompromising medications&#xD;
  &#xD;
            -  Transfer from another health facility.&#xD;
  &#xD;
          Clinician Inclusion Criteria:&#xD;
  &#xD;
            -  Prescribing clinicians (including attending physicians, fellows, residents, nurse&#xD;
               practitioners, and physician assistants) at one of the participating outpatient&#xD;
               practices or inpatient units.&#xD;
  &#xD;
            -  Age ≥ 18 years old&#xD;
  &#xD;
            -  Employed by one of the participating sites&#xD;
  &#xD;
          Clinician Exclusion Criteria:&#xD;
  &#xD;
            -  Volunteers or other non-employee hospital staff&#xD;
  &#xD;
            -  Limited English proficiency&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ebbing Lautenbach, MD, MSCE</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kathleen Chiotos, MD, MSCE</last_name>
      <phone>215-590-5505</phone>
      <email>chiotosk@chop.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lauren Dutcher, MD, MSCE</last_name>
      <phone>215-662-6932</phone>
      <email>ldutcher@pennmedicine.upenn.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's Hospital of Philadelphia</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kathleen Chiotos, MD, MSCE</last_name>
        <phone>215-590-5505</phone>
        <email>chiotosk@chop.edu</email>
      </contact>
      <contact_backup>
        <last_name>Didien Meyahnwi, MD, MPH</last_name>
        <phone>215-590-5505</phone>
        <email>meyahnwid@chop.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Jeffrey Gerber, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Pennsylvania Health System</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lauren Dutcher, MD, MSCE</last_name>
        <phone>215-662-6932</phone>
        <email>ldutcher@pennmedicine.upenn.edu</email>
      </contact>
      <contact_backup>
        <last_name>Anne Jaskowiak-Barr, MSW</last_name>
        <phone>215-898-8188</phone>
        <email>annejask@pennmedicine.upenn.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Keith Hamilton, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Julia Szymczak, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ebbing Lautenbach, MD, MSCE</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Gerber JS, Newland JG, Coffin SE, Hall M, Thurm C, Prasad PA, Feudtner C, Zaoutis TE. Variability in antibiotic use at children's hospitals. Pediatrics. 2010 Dec;126(6):1067-73. doi: 10.1542/peds.2010-1275. Epub 2010 Nov 15.</citation>
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    <reference>
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    <reference>
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      <citation>Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, Lynfield R, Margolis DJ, May LS, Merenstein D, Metlay JP, Newland JG, Piccirillo JF, Roberts RM, Sanchez GV, Suda KJ, Thomas A, Woo TM, Zetts RM, Hicks LA. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. doi: 10.1001/jama.2016.4151.</citation>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Antibiotic stewardship</keyword>
    <keyword>Implementation Science</keyword>
    <keyword>Antibiotic Use</keyword>
    <keyword>Outpatient antibiotic prescribing</keyword>
    <keyword>Inpatient antibiotic prescribing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pharyngitis</mesh_term>
      <mesh_term>Otitis Media</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.</ipd_description>
    </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/NCT06027593
  org study id: 22-019749
  secondary id: 75D30121F00002
  secondary id: 850722
  secondary id: 851400
  nct id: NCT06027593
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main goal of this study is to use automated electronic reports to assess and improve
        guideline-concordant antibiotic use for:
  
        1) adult inpatients with community-acquired pneumonia (CAP); 2) pediatric inpatients with
        CAP; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute
        otitis media.
  
        There are two cohorts in this study: Patients with one of the aforementioned conditions who
        meet inclusion criteria, and the clinicians providing clinical care to these patients.
  Antibiotic stewardship (AS) has been shown to improve patient outcomes, decrease adverse
        events, and decrease antibiotic resistance. This group of investigators previously partnered
        with collaborators at the Centers for Disease Control and Prevention (CDC) and conducted
        relevant pilot work in developing and validating electronic indicators of inappropriate
        antibiotic prescribing for 8 conditions, amongst which are the four conditions of interest in
        this study: adult inpatients with CAP; pediatric inpatients with CAP; adult outpatients with
        acute pharyngitis; and pediatric outpatients with acute pharyngitis). Methods were developed
        to generate automatic, routine reports to identify elements of inappropriate antibiotic use
        including; 1) the decision to initiate antibiotic therapy; 2) the choice of antibiotic agent;
        and 3) the duration of antibiotic use.
  
        The purpose of this project is to assess the impact of these developed electronic indicators
        on supporting AS efforts to improve the appropriateness of antibiotic use, as well as the
        acceptability and feasibility of delivering these reports to prescribers. The investigators
        aim to:
  
          1. Refine and validate indicators of appropriate antibiotic use by utilizing Electronic
             Health Record (EHR) data, including International Classification of Diseases (ICD-10)
             codes, medications, laboratory data, comorbid medical conditions, site of care, clinical
             documentation, prior hospitalizations, and medication exposure. The researchers will
             validate the definitions of the various conditions and appropriateness captured
             electronically with a manual chart review of clinical documentation.
  
          2. Implement a scalable and sustainable AS feedback report-based intervention for these
             four conditions informed by a rapid user-centered design process.
  
          3. Track the impact of stewardship interventions and report to key stakeholders, including
             prescribers.
  
          4. Create a publicly available toolkit based on the findings of this project that includes:
             (i) analytic tools and resources for using the automated reports of key indicators to
             target stewardship interventions and (ii) an implementation guide to inform the
             application of automated reports to stewardship in the inpatient and outpatient
             settings.
  
        If proven effective, these EHR-based approaches hold the promise to greatly enhance the
        effectiveness and efficiency of AS initiatives.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Guideline-concordant antibiotic Use for adult pharyngitis
  time frame: Up to 4 years
  description: This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).
  measure: Guideline-concordant antibiotic Use for pediatric acute otitis media
  time frame: Up to 4 years
  description: This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).
  measure: Guideline-concordant antibiotic Use for CAP
  time frame: Up to 4 years
  description: Percentage of CAP encounters with guideline-concordant antibiotic use for both the duration and choice metrics.
  measure: Guideline-concordant decision to prescribe antibiotics for adult pharyngitis
  time frame: Up to 4 years
  description: Percentage of patients for which the decision to prescribe an antibiotic was correct.
  measure: Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis
  time frame: Up to 4 years
  description: Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for adult pharyngitis
  measure: Guideline-concordant decision to prescribe antibiotics for pediatric acute otitis media
  time frame: Up to 4 years
  description: Percentage of patients for which the decision to prescribe an antibiotic was correct.
  measure: Guideline-concordant decision to not prescribe antibiotics for pediatric acute otitis media
  time frame: Up to 4 years
  description: Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for acute otitis media
  measure: Guideline-concordant antibiotic choice
  time frame: Up to 4 years
  description: Percentage of patients who received guideline-concordant antibiotic choice for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media.
  measure: Guideline-concordant antibiotic duration
  time frame: Up to 4 years
  description: Percentage of patients who received guideline-concordant antibiotic duration for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media
  measure: Return to the emergency department
  time frame: Up to 2 years
  description: Percentage of patients who return to the emergency department within 14 days of discharge following hospitalization for CAP.
  measure: Return to the clinic
  time frame: Up to 2 years
  description: Percentage of patients who return for an outpatient visit within 7 days of being diagnosed with adult pharyngitis or pediatric acute otitis media.
  measure: Readmissions within 14 days of the index visit for CAP
  time frame: Up to 2 years
  description: Percentage of inpatients with CAP who are readmitted within 14 days of the index visit for the same or related condition.
  measure: New antibiotic prescription within 7 days of the index visit
  time frame: Up to 2 years
  description: Percentage of patients who receive a new antibiotic prescription within 7 days of the index visit.
  measure: Measure of feasibility of intervention
  time frame: Up to 2 years
  description: Feasibility, the extent to which the intervention can be carried out in the clinical setting, will be determined in collaboration with our local stakeholders but may include the proportion of clinicians who attend educational sessions and/or unit-based meetings during which antibiotic use data is reviewed.
  measure: Acceptability of intervention
  time frame: Up to 2 years
  description: Acceptability, how well the intervention was received by the prescribing clinicians will be measured during surveys and structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree.
  arm group label: Prescribing Clinicians
  arm group type: Other
  description: During the pre-intervention period which will last up to approximately 24 months, investigators will retrospectively collect data on appropriate antibiotic prescribing for the conditions. In the post-intervention period of approximately 24 months, investigators will implement a provider-focused intervention, consisting of feedback reports to providers using the validated metrics of antibiotic prescribing. These measures are based on national guidelines for appropriate antibiotic prescribing. Following implementation of the intervention, the investigative team will collect the same measures.
  arm group label: Patients diagnosed with conditions of interest during study period
  arm group type: No Intervention
  description: Interactions between investigators and patients will be limited to review of existing EHR data. Investigators will have no direct contact with patients. The data from the University of Pennsylvania Health System (UPHS) and Children's Hospital of Philadelphia (CHOP) will be extracted from data warehouses that store data from the electronic health record. These data will be used in feedback report generation as well as in outcome assessment. An estimated total of 10,000 inpatients with CAP (adult and pediatric) will be recruited. Similarly, about 500,000 patients (adult pharyngitis and pediatric acute otitis media combined) will be recruited in the outpatient setting.
  intervention type: Behavioral
  intervention name: Mixed methods intervention
  description: Investigators will implement the intervention at the completion of the rapid user-centered design process and consultation with CDC collaborators.
  During the rapid user-centered design process, the team will engage key stakeholders to create and optimize feedback reports that will fit the prescribing context, and determine appropriate implementation supports that will be needed to accompany the introduction of the feedback reports to each setting.
  Following the initial awareness-building activities, investigators will circulate the antibiotic prescribing feedback reports. After the first 3 months (approximately) of report dissemination, the team will assess the feasibility and acceptability of the reports and implementation activities by administering a brief survey to prescribers and also conducting interviews with them. No direct identifiers will be collected.
  arm group label: Prescribing Clinicians
  other name: Quasi experimental intervention
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Ebbing Lautenbach, MD, MSCE
  role: Principal Investigator
  affiliation: University of Pennsylvania
  last name: Kathleen Chiotos, MD, MSCE
  phone: 215-590-5505
  email: chiotosk@chop.edu
  last name: Lauren Dutcher, MD, MSCE
  phone: 215-662-6932
  email: ldutcher@pennmedicine.upenn.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  citation: Gerber JS, Newland JG, Coffin SE, Hall M, Thurm C, Prasad PA, Feudtner C, Zaoutis TE. Variability in antibiotic use at children's hospitals. Pediatrics. 2010 Dec;126(6):1067-73. doi: 10.1542/peds.2010-1275. Epub 2010 Nov 15.
  PMID: 21078728
  citation: Polk RE, Hohmann SF, Medvedev S, Ibrahim O. Benchmarking risk-adjusted adult antibacterial drug use in 70 US academic medical center hospitals. Clin Infect Dis. 2011 Dec;53(11):1100-10. doi: 10.1093/cid/cir672. Epub 2011 Oct 13.
  PMID: 21998281
  citation: Roberts RM, Hicks LA, Bartoces M. Variation in US outpatient antibiotic prescribing quality measures according to health plan and geography. Am J Manag Care. 2016 Aug;22(8):519-23.
  PMID: 27541698
  citation: Hicks LA, Bartoces MG, Roberts RM, Suda KJ, Hunkler RJ, Taylor TH Jr, Schrag SJ. US outpatient antibiotic prescribing variation according to geography, patient population, and provider specialty in 2011. Clin Infect Dis. 2015 May 1;60(9):1308-16. doi: 10.1093/cid/civ076. Epub 2015 Mar 5.
  PMID: 25747410
  citation: Barnett ML, Linder JA. Antibiotic prescribing for adults with acute bronchitis in the United States, 1996-2010. JAMA. 2014 May 21;311(19):2020-2. doi: 10.1001/jama.2013.286141. No abstract available.
  PMID: 24846041
  citation: Barnett ML, Linder JA. Antibiotic prescribing to adults with sore throat in the United States, 1997-2010. JAMA Intern Med. 2014 Jan;174(1):138-40. doi: 10.1001/jamainternmed.2013.11673. No abstract available.
  PMID: 24091806
  citation: Fairlie T, Shapiro DJ, Hersh AL, Hicks LA. National trends in visit rates and antibiotic prescribing for adults with acute sinusitis. Arch Intern Med. 2012 Oct 22;172(19):1513-4. doi: 10.1001/archinternmed.2012.4089. No abstract available.
  PMID: 23007315
  citation: Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, Lynfield R, Margolis DJ, May LS, Merenstein D, Metlay JP, Newland JG, Piccirillo JF, Roberts RM, Sanchez GV, Suda KJ, Thomas A, Woo TM, Zetts RM, Hicks LA. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. doi: 10.1001/jama.2016.4151.
  PMID: 27139059
  citation: Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.
  PMID: 17173212
  citation: Gerber JS, Grundmeier R, Hamilton KW, Hicks L, Neuhauser M, Frager N, Menon M, Kratz E, Jaskowiak A, Cressman L, James T, Omorogbe J, Lautenbach E. Development of an Electronic Algorithm to Identify Inappropriate Antibiotic Prescribing for Pediatric Pharyngitis. Infection Control and Hospital Epidemiology. 2020;41 (S1):S188-189
  citation: Gerber JS, Grundmeier R, Hamilton KW, Hicks L, Neuhauser M, Frager N, Menon M, Kratz E, Jaskowiak A, Cressman L, James T, Omorogbe J, Lautenbach E. An Electronic Algorithm to Better Target Antimicrobial Stewardship Program (ASP) Efforts for Children Hospitalized with Community-Acquired Pneumonia (CAP). Open Forum Infectious Diseases. 2020;7 (S1):S85-86
  citation: Lautenbach E, Hamilton KH, Grundmeier R, Neuhauser M, Hicks L, Jaskowiak A, Cressman L, James T, Omorogbe J, Frager N, Menon M, Kratz E, Gerber JS. Development of an Electronic Algorithm to Target Outpatient Antimicrobial Stewardship Efforts for Acute Bronchitis. Infection Control and Hospital Epidemiology. 2020;41 (S1):S188-189
  citation: Lautenbach E, Hamilton KH, Grundmeier R, Neuhauser M, Hicks L, Jaskowiak A, Cressman L, James T, Omorogbe J, Frager N, Menon M, Kratz E, Gerber JS. Construction of an Electronic Algorithm to Efficiently Target Antimicrobial Stewardship Efforts for Adults Hospitalized with Community-acquired Pneumonia. Open Forum Infectious Diseases. 2020;7 (S1):S175-176
  citation: Lautenbach E, Hamilton KW, Grundmeier R, Neuhauser MM, Hicks LA, Jaskowiak-Barr A, Cressman L, James T, Omorogbe J, Frager N, Menon M, Kratz E, Dutcher L, Chiotos K, Gerber JS. Development of an Electronic Algorithm to Target Outpatient Antimicrobial Stewardship Efforts for Acute Bronchitis and Pharyngitis. Open Forum Infect Dis. 2022 Jun 6;9(7):ofac273. doi: 10.1093/ofid/ofac273. eCollection 2022 Jul.
  PMID: 35854991
  citation: Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
  PMID: 26864410
  citation: Charani E, Ahmad R, Rawson TM, Castro-Sanchez E, Tarrant C, Holmes AH. The Differences in Antibiotic Decision-making Between Acute Surgical and Acute Medical Teams: An Ethnographic Study of Culture and Team Dynamics. Clin Infect Dis. 2019 Jun 18;69(1):12-20. doi: 10.1093/cid/ciy844.
  PMID: 30445453
  citation: Szymczak JE. Are Surgeons Different? The Case for Bespoke Antimicrobial Stewardship. Clin Infect Dis. 2019 Jun 18;69(1):21-23. doi: 10.1093/cid/ciy847. No abstract available.
  PMID: 30445615
  citation: Landis-Lewis Z, Kononowech J, Scott WJ, Hogikyan RV, Carpenter JG, Periyakoil VS, Miller SC, Levy C, Ersek M, Sales A. Designing clinical practice feedback reports: three steps illustrated in Veterans Health Affairs long-term care facilities and programs. Implement Sci. 2020 Jan 21;15(1):7. doi: 10.1186/s13012-019-0950-y.
  PMID: 31964414
  citation: Redding LE, Muller BM, Szymczak JE. Small and Large Animal Veterinarian Perceptions of Antimicrobial Use Metrics for Hospital-Based Stewardship in the United States. Front Vet Sci. 2020 Sep 8;7:582. doi: 10.3389/fvets.2020.00582. eCollection 2020.
  PMID: 33102546
  citation: Szymczak JE, Feemster KA, Zaoutis TE, Gerber JS. Pediatrician perceptions of an outpatient antimicrobial stewardship intervention. Infect Control Hosp Epidemiol. 2014 Oct;35 Suppl 3:S69-78. doi: 10.1086/677826.
  PMID: 25222901
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  PMID: 30919799
  citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
  PMID: 28851459
  responsible party type: Sponsor
  mesh term: Pharyngitis
  mesh term: Otitis Media
  sharing ipd: No
  ipd description: This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.