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

Pneumonia Childhood Clinical Trial

— ICE-CAP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06033079
• Other study ID #: R01AI125642pt2
• Secondary ID: R01AI125642
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia Childhood

Intervention

Behavioral:
• Clinical Decision Support
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.

Locations

Country	Name	City	State
United States	Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of Allergy and Infectious Diseases (NIAID), University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death	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.	30 days
Primary	Inappropriate Disposition	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.	24 Hours
Secondary	Overall Site-of-care 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.	ED Disposition
Secondary	ED Revisits (72 Hours)	This outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.	72 hours
Secondary	ED Revisits (7 Days)	This outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.	7 days
Secondary	Rehospitalizations (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.	72 hours
Secondary	Rehospitalizations (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.	7 days