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Completed

NCT Number: NCT06033079

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

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.

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Key information

Conditions

Pneumonia Childhood

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Decision Support

Behavioral

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.

Primary outcomes

  1. 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.

    • Disposition: Discharged to home, Appropriate if no subsequent hospitalization within 24h
    • 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
    • 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

  1. Overall Site-of-care Disposition

    Time frame: ED Disposition

    This outcome reports the total number of participants who were initially discharged from the ED, admitted to the inpatient ward, or admitted to the ICU.

  2. ED Revisits (72 Hours)

    Time frame: 72 hours

    This outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.

  3. ED Revisits (7 Days)

    Time frame: 7 days

    This outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.

  4. Rehospitalizations (72 Hours)

    Time frame: 72 hours

    This outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 72 hours of the index discharge.

  5. Rehospitalizations (7 Days)

    Time frame: 7 days

    This outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 7 days of the index discharge.

Other outcomes

  1. Death

    Time frame: 30 days

    This outcome reports the number of participants who died as a result of their pneumonia-related illness within 30 days discharge from the index encounter.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of Pittsburgh Medical Center

Registry information

Official study title

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

Acronym: ICE-CAP2

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2023
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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