Clinical trial NCT06033079: Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP2)
Official title: Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Prognostic Decision Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia Childhood
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of Pittsburgh Medical Center
First posted: 2023-09-13
Enrollment: 536
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Six months to \<18 years of age
2. Radiographic evidence of pneumonia in ED
3. Provider-confirmed diagnosis of pneumonia

Exclusion Criteria:

1. Children with tracheostomy, cystic fibrosis, immunosuppression
2. Inter-hospital transfers
3. Hospitalization within preceding 7 days
4. Previously enrolled within preceding 28 days
5. Provider preference for any reason

Primary outcomes:
measure: Inappropriate Disposition
timeFrame: 24 Hours
Secondary outcomes:
measure: Overall Site-of-care Disposition
timeFrame: ED Disposition
measure: ED Revisits (72 Hours)
timeFrame: 72 hours
measure: ED Revisits (7 Days)
timeFrame: 7 days
measure: Rehospitalizations (72 Hours)
timeFrame: 72 hours
measure: Rehospitalizations (7 Days)
timeFrame: 7 days
Other outcomes:
measure: Death
timeFrame: 30 days
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Derek J Williams, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: