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

NCT06033079 | Completed Results DMC

• 2 other identifiers: R01AI125642pt2R01AI125642
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia Childhood

Outcome Measures

Primary Outcomes (1)

• 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. 1. Disposition: Discharged to home, Appropriate if no subsequent hospitalization within 24h 2. 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 3. 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 Outcomes (5)

• Overall Site-of-care Disposition

  ED Disposition

• ED Revisits (72 Hours)

  72 hours

• ED Revisits (7 Days)

  7 days

• Rehospitalizations (72 Hours)

  72 hours

• Rehospitalizations (7 Days)

  7 days

Other Outcomes (1)

• Death

  30 days

Study Arms (2)

CDS Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

CDS Intervention

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Six months to \<18 years of age
• Radiographic evidence of pneumonia in ED
• Provider-confirmed diagnosis of pneumonia

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of Pittsburgh Medical Center: collaborator

Study Sites (1)

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

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 38797872 DERIVED

Results Point of Contact

• Title: Derek J. Williams, MD, MPH
• Organization: Vanderbilt University Medical Center

derek.williams@vumc.org

615-322-2744

Study Officials

• Derek J Williams, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 13, 2023
• Study Start: November 20, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)