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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT06033079

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH), University of Pittsburgh Medical Center (Other)

536

Enrollment

Location

Arms

24.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Childhood	Behavioral: Clinical Decision Support	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

536 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 20, 2020

Actual Primary Completion Date :

Nov 30, 2022

Actual Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CDS Intervention The prognostic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.	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.
No Intervention: Control No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.

Arm

Intervention/Treatment

Experimental: CDS Intervention

The prognostic decision support application will be provided to those randomized to the intervention arm. Due to the nature of the intervention, blinding of treating providers will not be possible. All children will receive usual care and all treatment decisions will be made by the clinical providers and will not be restricted or altered in any way.

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.

No Intervention: Control

No experimental decision support will be provided to those randomized to the control arm. All children will receive usual care and treatment will not be restricted or altered in any way by the study.

Outcome Measures

Primary Outcome Measures

Number of participants disposed to appropriate site of care [24 months]
Number of participants who were disposed to the appropriate site of care according to the following definitions: Discharged to home (No subsequent hospitalization within 24h); Inpatient ward (Hospital length of stay (LOS) ≥ 24h OR hospital LOS < 24h but objective criteria for admission present (eg, need for supplemental oxygen)) AND no subsequent transfer to ICU within 24h; or ICU (ICU LOS ≥ 24h OR ICU LOS < 24h but objective criteria for ICU admission present (eg, respiratory failure))

Secondary Outcome Measures

Overall site-of-care disposition [24 months]
This secondary outcome reports the total number of participants who were discharged from the ED, admitted to the inpatient ward, and admitted to the ICU.
ED revisits (72 hours) [24 months]
This secondary outcome reports the number of participants who presented to the ED for care within 72 hours of the index discharge.
ED revisits (7 days) [24 months]
This secondary outcome reports the number of participants who presented to the ED for care within 7 days of the index discharge.
Rehospitalizations (72 hours) [24 months]
This secondary outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 72 hours of the index discharge.
Rehospitalizations (7 days) [24 months]
This secondary outcome reports the number of participants who were readmitted to the hospital for pneumonia-related illness within 7 days of the index discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

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

Investigators

Principal Investigator: Derek J Williams, MD, MPH, Vanderbilt University Medical Center

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Derek Williams, Associate Professor of Pediatrics, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT06033079

Other Study ID Numbers:

R01AI125642pt2
R01AI125642

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumonia

Study Results

No Results Posted as of Sep 13, 2023