Improving CarE for Community Acquired Pneumonia 1
Condition: Pneumonia Childhood
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Children with pneumonia presenting to the emergency department at Monroe Carell Jr.
      Children's Hospital at Vanderbilt or Children's Hospital of Pittsburgh will be potentially
      eligible for study. During intervention periods, providers caring for enrolled children will
      be presented with a detailed decision support strategy that emphasizes management in
      accordance with national guideline recommendations. The anticipated study duration is 18
      months and, as this study does not include direct contact with enrolled subjects, there is no
      anticipated follow up.
    

Detailed description: 
      Pneumonia is the most common serious infection in childhood. In the United States (US),
      pneumonia accounts for 1-4% of all emergency department (ED) visits in children (3-28 per
      1,000 US children per year) and ranks among the top 3 reasons for pediatric hospitalization
      with >100,000 hospitalizations per year (15-22 per 100,000 US children per year)2-5.
      Pneumonia also accounts for more days of antibiotic use in US children's hospitals than any
      other condition.

      Safely reducing inappropriate antibiotic use is critical to slow the progression of
      antimicrobial resistance, and childhood pneumonia is a key area where substantial
      improvements can be made. In the 2011 Pediatric Infectious Diseases Society/Infectious
      Diseases Society of America (PIDS/IDSA) pneumonia guideline, appropriate use of antibiotics
      was an important area of emphasis. For presumed bacterial pneumonia, recommendations
      emphasize the use of a single, narrow-spectrum antibiotic (i.e. amoxicillin or ampicillin).
      In children <6 years of age treated in the outpatient setting, the guideline recommended
      considering withholding antibiotics, recognizing that pneumonia in this population is most
      often caused by viruses. Both of these recommendations were graded as strong and supported by
      high-quality evidence. Nonetheless, in a large database study we conducted just prior to
      release of the 2011 guideline, use of broad-spectrum antibiotics was very common among
      children hospitalized with pneumonia, with substantial differences in antibiotic selection
      patterns among the various hospitals. In that study, use of narrow-spectrum ampicillin was
      rare (<5%). High rates of broad-spectrum antibiotic use were also noted in a study of
      children with pneumonia treated and released from US EDs, with <30% of children receiving
      narrow-spectrum therapy.

      Study Aim: To test the hypothesis that electronic antibiotic decision support increases
      guideline-concordant antibiotic use compared with usual care in the emergency department.

      The primary outcome is the proportion of children exclusively receiving guideline-concordant
      first line antibiotic therapy during the first 24 hours of care. Secondary outcomes include
      exclusive use of concordant antibiotic therapy for the entire episode, any use of concordant
      antibiotic therapy during the first 24 hours of care and for the entire episode, and
      emergency department revisits and hospitalizations within 72 hours and 7 days of the index
      discharge.

      In this study, conducted at two experienced academic centers, the investigator will implement
      and evaluate an electronic health record based clinical decision support application to
      promote antibiotic use in concordance with the 2011 PIDS/IDSA guideline in a pragmatic,
      cluster randomized trial. Decisions regarding management, including antibiotic selection and
      site of care, will be at the discretion of the treating provider and will not be restricted
      or altered in any way. Thus, this study poses no greater than minimal risks to participants.
      Due to the nature of the research, waiver of informed consent has been provided, as it has
      been done in similar pragmatic studies at the institutions.
    

Intervention name(s): Clinical Decision Support
Intervention type(s): Behavioral
Intervention description(s): For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Effectiveness of the EHR-based antibiotic decision support application for promoting guideline-concordant antibiotic prescribing in children presenting for emergency care will be evaluated in a pragmatic, cluster-randomized study conducted over a period of 18 months that includes two respiratory seasons. Randomization will occur monthly at each hospital. To ensure balanced representation of each arm in periods of both low and high pneumonia prevalence, randomization will occur in 3 permuted blocks (size=6).
Masking: None (Open Label)
Primary purpose: Health Services Research