Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2)
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 24
      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). 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.
    

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 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.
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.
Masking: None (Open Label)
Primary purpose: Health Services Research