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

NCT ID: NCT06033079

Last Updated: 2023-12-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2022-11-30

Brief Summary

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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

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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.

Conditions

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Pneumonia Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical Decision Support

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Derek Williams

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derek J Williams, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Williams DJ, Nian H, Suresh S, Slagle J, Gradwohl S, Johnson J, Stassun J, Reale C, Just SL, Rixe NS, Beebe R, Arnold DH, Turer RW, Antoon JW, Sartori LF, Freundlich RE, Grijalva CG, Smith JC, Weitkamp AO, Weinger MB, Zhu Y, Martin JM. Prognostic clinical decision support for pneumonia in the emergency department: A randomized trial. J Hosp Med. 2024 Sep;19(9):802-811. doi: 10.1002/jhm.13391. Epub 2024 May 26.

Reference Type DERIVED
PMID: 38797872 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R01AI125642

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AI125642pt2

Identifier Type: -

Identifier Source: org_study_id