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/NCT06034080</url>
    </required_header>
    <id_info>
      <org_study_id>23-1096</org_study_id>
      <secondary_id>IHS-2022C2-28005</secondary_id>
      <nct_id>NCT06034080</nct_id>
    </id_info>
    <brief_title>Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections</brief_title>
    <acronym>DISAPEAR</acronym>
    <official_title>DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Denver Health and Hospital Authority</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AllianceChicago</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Intermountain Health Care, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Patient-Centered Outcomes Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Denver Health and Hospital Authority</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>
        This study aims to improve care and reduce unnecessary antibiotic prescribing for children&#xD;
        with ear infections. The study will compare the effectiveness of a &quot;gold standard&quot; to a&#xD;
        hybrid intervention combined with this gold standard, in order to identify steps to increase&#xD;
        parent satisfaction for child ear infection care. The &quot;gold standard&quot; approach is a Health&#xD;
        System Level Intervention. On its own, it involves clinician education, tools in electronic&#xD;
        medical records, and audit and feedback reports for clinician prescribing habits. The hybrid&#xD;
        intervention includes the elements of the health systems level intervention in addition to a&#xD;
        Shared Decision-Making component, which allows for both an increase in the role parents play&#xD;
        in their child's care, as well as clinician education for how to use this method. The goals&#xD;
        of this work are to increase parent satisfaction, reduce antibiotics taken for childhood ear&#xD;
        infections, align medical care with the current national guidelines, and evaluate differences&#xD;
        in the two intervention groups. Both groups will be evaluated for implementation outcomes to&#xD;
        improve dissemination and scalability for future use of these models in antibiotic&#xD;
        prescribing for children with ear infections.&#xD;
  &#xD;
        This study will recruit a diverse group of patients and clinicians to complete surveys,&#xD;
        parents to participate in focus groups, and clinicians and administrators to be interviewed&#xD;
        in order to meet study aims and receive sufficient feedback on the interventions performed.&#xD;
        There are two hypotheses for this research: 1. The Hybrid Intervention will have higher&#xD;
        parent satisfaction and reduced antibiotic use compared to the Health-System Level&#xD;
        Intervention and 2. The Hybrid Intervention will be more challenging to implement than the&#xD;
        Health-System Level Intervention, but will be preferred by parents, clinicians, and&#xD;
        administrators.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acute otitis media (AOM), commonly referred to as an ear infection, is the most common reason&#xD;
        children are prescribed antibiotics, affecting 5 million children and resulting in 10 million&#xD;
        antibiotic prescriptions annually. By 3 years of age over 60% of children will have had AOM.&#xD;
        Though 84% of AOM episodes resolve without antibiotics, antibiotics are prescribed to &gt;95% of&#xD;
        children. The American Academy of Pediatrics (AAP) recommends that most children with AOM do&#xD;
        not receive an immediate antibiotic (an antibiotic to take right away) and instead be managed&#xD;
        with watchful waiting, where an antibiotic is used only if the child worsens or does not&#xD;
        improve. In clinical trials watchful waiting reduced antibiotic use by over 62% and did not&#xD;
        result in increased complications, reduced parent satisfaction, or increased symptoms.&#xD;
        Unfortunately, despite these trials &lt;5% of children with AOM are managed with watchful&#xD;
        waiting. The use of antibiotics when not needed contributes to the development of antibiotic&#xD;
        resistant organisms, which makes future infections more difficult to treat. Additionally,&#xD;
        unnecessary antibiotics reduce pediatric quality of life and over 26% of children who take an&#xD;
        antibiotic experience an adverse drug event (ADE). Thus, for every 100 children with AOM who&#xD;
        take an antibiotic at least 26 children experience harm; whereas only 5 children have&#xD;
        symptomatic benefit.&#xD;
  &#xD;
        This study aims to compare the effectiveness of two pragmatic interventions to improve&#xD;
        patient-centered outcomes and reduce unnecessary antibiotics taken for AOM. Interventions&#xD;
        will be conducted at 29 community-based clinics and/or urgent care centers across three&#xD;
        distinct geographic regions in the United States. Randomization will occur at the clinic&#xD;
        center level to either the gold standard approach or the hybrid intervention. The Practical&#xD;
        Robust Implementation and Sustainability Model (PRISM) will be used to guide implementation&#xD;
        and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework will be&#xD;
        used to evaluate outcomes. A mixed-methods approach will be used in the pre-implementation&#xD;
        and evaluation phases and will utilize quantitative analyses, semi-structured interviews,&#xD;
        focus groups, and surveys.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2024</start_date>
    <completion_date type="Anticipated">June 2029</completion_date>
    <primary_completion_date type="Anticipated">April 2027</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>Mutli-Center Cluster Randomized Trial</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Increase in Parent Satisfaction</measure>
      <time_frame>10 days after clinic visit for ear infection</time_frame>
      <description>Survey responses will be measured by the percentage of &quot;Very Satisfied&quot; or &quot;Extremely Satisfied&quot; responses from parents on a 7-point Likert Scale. The survey tool will be created from adaptations to the Pediatric Quality of Life Inventory (PedsQL) and the Acute Otitis Media Severity of Symptom Scale (AOM-SOS). In this survey, the higher scores on the Likert Scale will indicate more overall parent satisfaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Patients Taking an Antibiotic for AOM</measure>
      <time_frame>10 days after clinic visit for ear infection</time_frame>
      <description>Comparing electronic health record prescription data with parent yes/no survey responses to a question on whether or not their child took an antibiotic prescribed for treating their ear infection.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Shared Decision-Making</measure>
      <time_frame>At time of clinic visit for ear infection (0 Days)</time_frame>
      <description>Summed score of the &quot;Knowledge and Decisional Conflict Assessment&quot; section of the Shared Decision-Making Questionnaire (SDM Q-9). The survey has a 6-Point Likert Scale ranging in values from &quot;Completely Disagree&quot; to &quot;Completely Agree&quot;. For this survey, the higher the number on the Likert Scale, the better the outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pediatric Quality of Life</measure>
      <time_frame>10 days after clinic visit for ear infection</time_frame>
      <description>Score on the PEDS-QL Survey. This survey has a 5-Point Likert Scale ranging from &quot;Never a Problem&quot; (0 points) to &quot;Almost Always a Problem&quot; (4 points). Higher scores on this scale indicate worse outcomes while lower scores indicate better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptom and Severity Duration</measure>
      <time_frame>0 and 10 days after clinic visit for ear infection</time_frame>
      <description>Scores on a Likert scale from the AOM-Severity of Symptom scale survey on the following measures:&#xD;
  Symptom Severity (at maximum and at 10 days)&#xD;
  Time to Symptom Improvement (from onset)&#xD;
  Time to All Symptom Resolution (from onset)&#xD;
  Time to Ear Pain Resolution (from onset)&#xD;
  Symptoms Resolved at Day 10 (yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Missed Work/School/Daycare</measure>
      <time_frame>10 days after clinic visit for ear infection</time_frame>
      <description>Numbers of days child missed school/daycare and/or number of days parent(s) missed work</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse Drug Events</measure>
      <time_frame>10 days after clinic visit for ear infection</time_frame>
      <description>Percentage of patients with adverse drug event(s)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Failure</measure>
      <time_frame>10 days after clinic visit for ear infection</time_frame>
      <description>Percentage that changed their medication management (i.e., took an antibiotic if initially trying watchful waiting or tried a new antibiotic if initially immediately tried antibiotics)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Management Strategy</measure>
      <time_frame>At time of clinic visit for ear infection (0 Days)</time_frame>
      <description>Percentage of immediate antibiotic use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antibiotic Prescription Filled</measure>
      <time_frame>10 days after clinic visit for ear infection</time_frame>
      <description>Percentage of filled antibiotic prescriptions (even if not taken)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1450</enrollment>
    <condition>Acute Otitis Media</condition>
    <condition>Ear Infection</condition>
    <condition>Pediatric Infectious Disease</condition>
    <arm_group>
      <arm_group_label>Health System Level (HSL) Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The HSL Intervention is based on the CDC Core Elements of Stewardship and the HSL intervention is recommended by national guidelines. Sites randomized to this arm will require:&#xD;
  A change in their Electronic Health Record to their prescription fields to align with national guidelines&#xD;
  Individualized feedback report to their clinicians and clinic overall&#xD;
  And virtual learning sessions and continuing medical education credits for clinicians.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hybrid Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Hybrid Intervention will be comprised of Shared Decision-Making (SDM) and the HSL Intervention. A previously validated SDM aid for ear infection care will be implemented. The aid was developed using the International Patient Decision Aid Standards and is freely available. Sites randomized to this arm will require all of the HSL components as well as:&#xD;
  Use of the Shared-Decision Aide&#xD;
  Clinician Education on SDM</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Changes to the electronic health record (EHR)</intervention_name>
      <description>EHR changes will include minor changes to prescription fields to make it easier for clinicians to order &quot;wait and see&quot; antibiotics to be filled only if the child worsens or does not improve rather than antibiotics to take immediately.</description>
      <arm_group_label>Health System Level (HSL) Intervention</arm_group_label>
      <arm_group_label>Hybrid Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Individualized audit and feedback reporting for clinicians</intervention_name>
      <description>Automated audit and feedback reports detailing participating clinicians' antibiotic prescribing habits for AOM both individually and in comparison to their peers will be shared with clinicians on a quarterly basis throughout the intervention period.</description>
      <arm_group_label>Health System Level (HSL) Intervention</arm_group_label>
      <arm_group_label>Hybrid Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Clinician education sessions</intervention_name>
      <description>Virtual education sessions will be held for clinicians to learn more about national guidelines for antibiotic prescribing for AOM, etc. The sessions will be recorded and distributed to clinicians who were unable to attend. Attendance of these sessions will apply toward continuing medical education credits for participants.</description>
      <arm_group_label>Health System Level (HSL) Intervention</arm_group_label>
      <arm_group_label>Hybrid Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Use of a shared decision-making (SDM) aide</intervention_name>
      <description>A previously validated SDM aide for AOM will be used by clinicians during visits with children with AOM. The aide will be available online and in paper form.</description>
      <arm_group_label>Hybrid Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Shared decision-making (SDM) education</intervention_name>
      <description>Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.</description>
      <arm_group_label>Hybrid Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          A. Implementation of Interventions 1. Clinic at a participating organization 2. Provides&#xD;
          care to children with AOM 3. Administrative or local approval for participation&#xD;
  &#xD;
          B. Secondary Electronic Health Record Data&#xD;
  &#xD;
            1. Aged 6 months-17-years-old (inclusive)&#xD;
  &#xD;
            2. Diagnosis of AOM by ICD10 code&#xD;
  &#xD;
          C. Video recordings or direct observation of the use of a shared decision aid&#xD;
  &#xD;
          Parent participation:&#xD;
  &#xD;
            1. Child aged 6 months-17 years (inclusive)&#xD;
  &#xD;
            2. Diagnosed with AOM by clinician&#xD;
  &#xD;
            3. Parent or legal guardian is present and is &gt;=18 years or older&#xD;
  &#xD;
          Clinician Participation:&#xD;
  &#xD;
            1. Licensed clinician and not a medical trainee&#xD;
  &#xD;
            2. Age 18 &gt;= years or older&#xD;
  &#xD;
          D. Pre-implementation interviews of clinicians and administrators&#xD;
  &#xD;
            1. Licensed clinician (physician or advanced practice clinician) that cares for children&#xD;
               with AOM at a participating organization or an administrator/manager at a&#xD;
               participating organization.&#xD;
  &#xD;
            2. Aged &gt;=18 years-no maximum&#xD;
  &#xD;
          E. Pre-implementation focus groups of parents&#xD;
  &#xD;
            1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had&#xD;
               AOM diagnosed at a participating organization.&#xD;
  &#xD;
            2. 18 years of age or older and able/willing to consent&#xD;
  &#xD;
          F. Parents enrolled for surveys&#xD;
  &#xD;
          1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM&#xD;
          diagnosed at a participating organization. 2. Willing to participate and able to complete&#xD;
          electronic surveys at enrollment and 10 days after enrollment. 3. Working phone 4. Age &gt;=18&#xD;
          years of age&#xD;
  &#xD;
          G. Post-intervention focus groups of parents&#xD;
  &#xD;
            1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had&#xD;
               AOM diagnosed at a participating organization.&#xD;
  &#xD;
            2. 18 years of age or older and able/willing to consent&#xD;
  &#xD;
          H. Post-intervention surveys of clinicians and administrators&#xD;
  &#xD;
            1. Licensed clinician (physician or advanced practice clinician) that cares for children&#xD;
               with AOM at a participating organization or an administrator/manager at a&#xD;
               participating organization.&#xD;
  &#xD;
            2. Aged &gt;=18 years-no maximum&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          A. Implementation of Interventions&#xD;
  &#xD;
          1. Clinics that exclusively provide telehealth&#xD;
  &#xD;
          B. Secondary Electronic Health Record Data&#xD;
  &#xD;
          1. None&#xD;
  &#xD;
          C. Video recordings or direct observation of the use of a shared decision aid&#xD;
  &#xD;
          Parent participation:&#xD;
  &#xD;
          1. None&#xD;
  &#xD;
          Clinician Participation:&#xD;
  &#xD;
          1. None&#xD;
  &#xD;
          D. Pre-implementation interviews of clinicians and administrators 1. Medical trainee&#xD;
          (student, resident, fellow, etc.)&#xD;
  &#xD;
          E. Pre-implementation focus groups of parents&#xD;
  &#xD;
          1. None&#xD;
  &#xD;
          F. Parents enrolled for surveys 1. Complicated or recurrent AOM as determined by the study&#xD;
          team&#xD;
  &#xD;
          G. Post-intervention focus groups of parents 1. None&#xD;
  &#xD;
          H. Post-intervention surveys of clinicians and administrators&#xD;
  &#xD;
          1. Medical trainee (student, resident, fellow, etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Holly Frost, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Denver Health and Hospital Authority</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Theresa L Morin, MA</last_name>
      <phone>303-602-5423</phone>
      <email>Theresa.Morin@dhha.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Holly M Frost, MD</last_name>
      <phone>303-602-6461</phone>
      <email>Holly.Frost@dhha.org</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Shared Decision-Making</keyword>
    <keyword>Health-System Level Intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Otitis</mesh_term>
      <mesh_term>Otitis Media</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will not be shared with other researchers.</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/NCT06034080
  org study id: 23-1096
  secondary id: IHS-2022C2-28005
  nct id: NCT06034080
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to improve care and reduce unnecessary antibiotic prescribing for children
        with ear infections. The study will compare the effectiveness of a "gold standard" to a
        hybrid intervention combined with this gold standard, in order to identify steps to increase
        parent satisfaction for child ear infection care. The "gold standard" approach is a Health
        System Level Intervention. On its own, it involves clinician education, tools in electronic
        medical records, and audit and feedback reports for clinician prescribing habits. The hybrid
        intervention includes the elements of the health systems level intervention in addition to a
        Shared Decision-Making component, which allows for both an increase in the role parents play
        in their child's care, as well as clinician education for how to use this method. The goals
        of this work are to increase parent satisfaction, reduce antibiotics taken for childhood ear
        infections, align medical care with the current national guidelines, and evaluate differences
        in the two intervention groups. Both groups will be evaluated for implementation outcomes to
        improve dissemination and scalability for future use of these models in antibiotic
        prescribing for children with ear infections.
  
        This study will recruit a diverse group of patients and clinicians to complete surveys,
        parents to participate in focus groups, and clinicians and administrators to be interviewed
        in order to meet study aims and receive sufficient feedback on the interventions performed.
        There are two hypotheses for this research: 1. The Hybrid Intervention will have higher
        parent satisfaction and reduced antibiotic use compared to the Health-System Level
        Intervention and 2. The Hybrid Intervention will be more challenging to implement than the
        Health-System Level Intervention, but will be preferred by parents, clinicians, and
        administrators.
  Acute otitis media (AOM), commonly referred to as an ear infection, is the most common reason
        children are prescribed antibiotics, affecting 5 million children and resulting in 10 million
        antibiotic prescriptions annually. By 3 years of age over 60% of children will have had AOM.
        Though 84% of AOM episodes resolve without antibiotics, antibiotics are prescribed to >95% of
        children. The American Academy of Pediatrics (AAP) recommends that most children with AOM do
        not receive an immediate antibiotic (an antibiotic to take right away) and instead be managed
        with watchful waiting, where an antibiotic is used only if the child worsens or does not
        improve. In clinical trials watchful waiting reduced antibiotic use by over 62% and did not
        result in increased complications, reduced parent satisfaction, or increased symptoms.
        Unfortunately, despite these trials <5% of children with AOM are managed with watchful
        waiting. The use of antibiotics when not needed contributes to the development of antibiotic
        resistant organisms, which makes future infections more difficult to treat. Additionally,
        unnecessary antibiotics reduce pediatric quality of life and over 26% of children who take an
        antibiotic experience an adverse drug event (ADE). Thus, for every 100 children with AOM who
        take an antibiotic at least 26 children experience harm; whereas only 5 children have
        symptomatic benefit.
  
        This study aims to compare the effectiveness of two pragmatic interventions to improve
        patient-centered outcomes and reduce unnecessary antibiotics taken for AOM. Interventions
        will be conducted at 29 community-based clinics and/or urgent care centers across three
        distinct geographic regions in the United States. Randomization will occur at the clinic
        center level to either the gold standard approach or the hybrid intervention. The Practical
        Robust Implementation and Sustainability Model (PRISM) will be used to guide implementation
        and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework will be
        used to evaluate outcomes. A mixed-methods approach will be used in the pre-implementation
        and evaluation phases and will utilize quantitative analyses, semi-structured interviews,
        focus groups, and surveys.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Mutli-Center Cluster Randomized Trial
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Increase in Parent Satisfaction
  time frame: 10 days after clinic visit for ear infection
  description: Survey responses will be measured by the percentage of "Very Satisfied" or "Extremely Satisfied" responses from parents on a 7-point Likert Scale. The survey tool will be created from adaptations to the Pediatric Quality of Life Inventory (PedsQL) and the Acute Otitis Media Severity of Symptom Scale (AOM-SOS). In this survey, the higher scores on the Likert Scale will indicate more overall parent satisfaction.
  measure: Percentage of Patients Taking an Antibiotic for AOM
  time frame: 10 days after clinic visit for ear infection
  description: Comparing electronic health record prescription data with parent yes/no survey responses to a question on whether or not their child took an antibiotic prescribed for treating their ear infection.
  measure: Shared Decision-Making
  time frame: At time of clinic visit for ear infection (0 Days)
  description: Summed score of the "Knowledge and Decisional Conflict Assessment" section of the Shared Decision-Making Questionnaire (SDM Q-9). The survey has a 6-Point Likert Scale ranging in values from "Completely Disagree" to "Completely Agree". For this survey, the higher the number on the Likert Scale, the better the outcome.
  measure: Pediatric Quality of Life
  time frame: 10 days after clinic visit for ear infection
  description: Score on the PEDS-QL Survey. This survey has a 5-Point Likert Scale ranging from "Never a Problem" (0 points) to "Almost Always a Problem" (4 points). Higher scores on this scale indicate worse outcomes while lower scores indicate better outcomes.
  measure: Symptom and Severity Duration
  time frame: 0 and 10 days after clinic visit for ear infection
  description: Scores on a Likert scale from the AOM-Severity of Symptom scale survey on the following measures:
  Symptom Severity (at maximum and at 10 days)
  Time to Symptom Improvement (from onset)
  Time to All Symptom Resolution (from onset)
  Time to Ear Pain Resolution (from onset)
  Symptoms Resolved at Day 10 (yes/no)
  measure: Missed Work/School/Daycare
  time frame: 10 days after clinic visit for ear infection
  description: Numbers of days child missed school/daycare and/or number of days parent(s) missed work
  measure: Adverse Drug Events
  time frame: 10 days after clinic visit for ear infection
  description: Percentage of patients with adverse drug event(s)
  measure: Treatment Failure
  time frame: 10 days after clinic visit for ear infection
  description: Percentage that changed their medication management (i.e., took an antibiotic if initially trying watchful waiting or tried a new antibiotic if initially immediately tried antibiotics)
  measure: Management Strategy
  time frame: At time of clinic visit for ear infection (0 Days)
  description: Percentage of immediate antibiotic use
  measure: Antibiotic Prescription Filled
  time frame: 10 days after clinic visit for ear infection
  description: Percentage of filled antibiotic prescriptions (even if not taken)
  arm group label: Health System Level (HSL) Intervention
  arm group type: Active Comparator
  description: The HSL Intervention is based on the CDC Core Elements of Stewardship and the HSL intervention is recommended by national guidelines. Sites randomized to this arm will require:
  A change in their Electronic Health Record to their prescription fields to align with national guidelines
  Individualized feedback report to their clinicians and clinic overall
  And virtual learning sessions and continuing medical education credits for clinicians.
  arm group label: Hybrid Intervention
  arm group type: Experimental
  description: The Hybrid Intervention will be comprised of Shared Decision-Making (SDM) and the HSL Intervention. A previously validated SDM aid for ear infection care will be implemented. The aid was developed using the International Patient Decision Aid Standards and is freely available. Sites randomized to this arm will require all of the HSL components as well as:
  Use of the Shared-Decision Aide
  Clinician Education on SDM
  intervention type: Other
  intervention name: Changes to the electronic health record (EHR)
  description: EHR changes will include minor changes to prescription fields to make it easier for clinicians to order "wait and see" antibiotics to be filled only if the child worsens or does not improve rather than antibiotics to take immediately.
  arm group label: Health System Level (HSL) Intervention
  arm group label: Hybrid Intervention
  intervention type: Other
  intervention name: Individualized audit and feedback reporting for clinicians
  description: Automated audit and feedback reports detailing participating clinicians' antibiotic prescribing habits for AOM both individually and in comparison to their peers will be shared with clinicians on a quarterly basis throughout the intervention period.
  arm group label: Health System Level (HSL) Intervention
  arm group label: Hybrid Intervention
  intervention type: Other
  intervention name: Clinician education sessions
  description: Virtual education sessions will be held for clinicians to learn more about national guidelines for antibiotic prescribing for AOM, etc. The sessions will be recorded and distributed to clinicians who were unable to attend. Attendance of these sessions will apply toward continuing medical education credits for participants.
  arm group label: Health System Level (HSL) Intervention
  arm group label: Hybrid Intervention
  intervention type: Other
  intervention name: Use of a shared decision-making (SDM) aide
  description: A previously validated SDM aide for AOM will be used by clinicians during visits with children with AOM. The aide will be available online and in paper form.
  arm group label: Hybrid Intervention
  intervention type: Other
  intervention name: Shared decision-making (SDM) education
  description: Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.
  arm group label: Hybrid Intervention
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 17 Years
  healthy volunteers: No
  last name: Holly Frost, MD
  role: Principal Investigator
  affiliation: Denver Health and Hospital Authority
  last name: Theresa L Morin, MA
  phone: 303-602-5423
  email: Theresa.Morin@dhha.org
  last name: Holly M Frost, MD
  phone: 303-602-6461
  email: Holly.Frost@dhha.org
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Otitis
  mesh term: Otitis Media
  sharing ipd: No
  ipd description: IPD will not be shared with other researchers.