Improving CarE for Community Acquired Pneumonia 1

NCT03760419 | Completed Results DMC

• 1 other identifier: R01AI125642
• Study Type: interventional
• Target: 1,027
• 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 18 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)

• Exclusive Guideline-Concordant Antibiotic Therapy, First 24 Hours

  The primary outcome is the percentage of children in which ALL antibiotic treatment prescribed in the first 24 hours of the encounter is guideline-concordant.

  18 months

Secondary Outcomes (3)

• Exclusive Guideline-Concordant Antibiotic Prescribing, Entire Episode

  18 months

• Any Guideline-Concordant Antibiotic Prescribing, First 24 Hours

  18 months

• Any Guideline-Concordant Antibiotic Prescribing, Entire Episode

  18 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The antibiotic 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 Arm

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 antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan.

Intervention Arm

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 (via Clinical Decision Support \[CDS\])

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

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: Derek Williams, Principal Investigator

Model Details: Effectiveness of the EHR-based antibiotic decision support application for promoting guideline-concordant antibiotic prescribing in children presenting for emergency care will be evaluated in a pragmatic, cluster-randomized study conducted over a period of 18 months that includes two respiratory seasons. Randomization will occur monthly at each hospital. To ensure balanced representation of each arm in periods of both low and high pneumonia prevalence, randomization will occur in 3 permuted blocks (size=6).

Study Record Dates

• First Submitted: September 15, 2018
• First Posted: November 30, 2018
• Study Start: December 17, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 8, 2022
• Results First Posted: December 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)