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Clinical Trials/NCT06033079
NCT06033079
Completed
Not Applicable

Improving CarE for Community Acquired Pneumonia 1 (ICE-CAP1): Prognostic Decision Support

Vanderbilt University Medical Center1 site in 1 country536 target enrollmentNovember 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia Childhood
Sponsor
Vanderbilt University Medical Center
Enrollment
536
Locations
1
Primary Endpoint
Inappropriate Disposition
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2020
End Date
November 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Derek Williams

Associate Professor of Pediatrics

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Six months to \<18 years of age
  • Radiographic evidence of pneumonia in ED
  • Provider-confirmed diagnosis of pneumonia

Exclusion Criteria

  • Children with tracheostomy, cystic fibrosis, immunosuppression
  • Inter-hospital transfers
  • Hospitalization within preceding 7 days
  • Previously enrolled within preceding 28 days
  • Provider preference for any reason

Outcomes

Primary Outcomes

Inappropriate Disposition

Time Frame: 24 Hours

Number of participants who were disposed from the ED and experienced a change in level of care within 24 hours unless objective criteria present. Appropriate dispositions were defined as follows. 1. Disposition: Discharged to home, Appropriate if no subsequent hospitalization within 24h 2. Disposition: Inpatient Ward, Appropriate if hospital length of stay (LOS) ≥ 24h OR hospital LOS \< 24h with objective criteria for admission present (eg, need for supplemental oxygen) PLUS no transfer to intensive care (ICU) within 24h 3. Disposition: ICU, ICU LOS ≥ 24h OR ICU LOS \< 24h with objective criteria for ICU admission present (eg, respiratory failure) Encounters NOT meeting these criteria were defined as Inappropriate.

Secondary Outcomes

  • ED Revisits (72 Hours)(72 hours)
  • ED Revisits (7 Days)(7 days)
  • Overall Site-of-care Disposition(ED Disposition)
  • Rehospitalizations (72 Hours)(72 hours)
  • Rehospitalizations (7 Days)(7 days)

Study Sites (1)

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