Viewing Study NCT06033079



Ignite Creation Date: 2024-05-06 @ 7:30 PM
Last Modification Date: 2024-10-26 @ 3:08 PM
Study NCT ID: NCT06033079
Status: COMPLETED
Last Update Posted: 2023-12-05
First Post: 2023-08-23

Brief Title: Improving CarE for Community Acquired Pneumonia 1 ICE-CAP2
Sponsor: Vanderbilt University Medical Center
Organization: Vanderbilt University Medical Center

Study Overview

Official Title: Improving CarE for Community Acquired Pneumonia 1 ICE-CAP1 Prognostic Decision Support
Status: COMPLETED
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ICE-CAP2
Brief Summary: Children with pneumonia presenting to the emergency department at Monroe Carell Jr Childrens Hospital at Vanderbilt or Childrens 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 1000 US children per year and ranks among the top 3 reasons for pediatric hospitalization with 100000 hospitalizations per year 15-22 per 100000 US children per year Pneumonia also accounts for more days of antibiotic use in US childrens 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 childrens 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 2000 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01AI125642 NIH None httpsreporternihgovquickSearchR01AI125642