Reducing Antibiotic Use by Implementation of Stewardship in Primary and Urgent Care

NCT07217002 | Active Not Recruiting

• 1 other identifier: 24-021996
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to reduce unnecessary antibiotic use for children with ARTIs (Acute Respiratory Tract Infections) by implementing "outpatient antibiotic stewardship" across the Children's Hospital of Philadelphia (CHOP) Primary and Urgent Care Network to:

1. 1.Reduce unnecessary antibiotic prescribing for the most common infections in children.
2. 2.Reduce unnecessary a) broad-spectrum and b) longer-course antibiotic therapy for ear infections, Strep throat, sinus infections, and pneumonia.

Conditions

Community Acquired Pneumonia (CAP); Sinusitis; Strep Pharyngitis; Acute Otitis Media (AOM)

Keywords

Antibiotics; Antimicrobial Stewardship

Outcome Measures

Primary Outcomes (4)

• Antibiotic Prescribing Rates for Acute Respiratory Tract Infections (ARTIs)

  ARTIs as measured by overall rates of prescribing an antibiotic during clinic visits for an acute respiratory tract infection (URI) diagnosis, including both bacterial and viral URIs using the EHR (electronic health record). Goal is that antibiotics are prescribed at 40% or fewer ARTI visits. The optimal proportion of ARTI visits that should be associated with an antibiotic prescription is unknown. Baseline prescribing rates for antibiotics in the Network ranges from 34-61%. The target 40% rate is currently achieved by 10% of our practices with the lowest antibiotic prescribing.

  From start of implementation ramp up period to end of year 2 implementation

• Change in overall optimal antibiotic prescribing rates for all bacterial ARTI encounters

  Changing overall antibiotic prescribing rates as measured by a composite of 1) narrow antibiotic selection and 2) shortest effective duration as a proportion of all antibiotics prescribed for each of the target diagnoses: Acute otitis media, Group A streptococcal pharyngitis, Acute sinusitis, and Pneumonia using EHR (electronic health record) data. This metric combines both narrow-spectrum antibiotic choice and optimal durations of therapy to comprehensively evaluate optimal antibiotic prescribing. At least 90% of antibiotics prescribed for ARTI are for optimal short duration and narrow spectrum antibiotics

  From start of implementation ramp up period to end of year 2 implementation

• Broad- versus Narrow-Spectrum Antibiotic Prescribing

  Broad vs. Narrow-Spectrum antibiotic prescribing as measured by rates of broad-spectrum antibiotics as a proportion of all antibiotics prescribed within each of these diagnoses using the EHR (electronic health record): * acute otitis media * Group A streptococcal pharyngitis * acute sinusitis * pneumonia At least 90% of antibiotics prescribed for ARTI are for optimal narrow spectrum antibiotics.

  From start of implementation ramp up period to end of year 2 implementation

• Shortest Effective Duration Antibiotic Prescribing

  Shortest effective duration measured by rates of prescribing the shortest effective duration of antibiotics as a proportion of all antibiotics prescribed within each of these diagnoses: * acute otitis media * Group A streptococcal pharyngitis * acute sinusitis * pneumonia At least 90% of antibiotics prescribed for ARTI are for the shortest effective duration of antibiotics. Optimizing durations of therapy will reduce overall antibiotic days and, therefore, decrease the overall antibiotic burden for children with ARTIs.

  From start of implementation ramp up period to end of year 2 implementation

Secondary Outcomes (3)

• Treatment failure or modification 14 days

  14 days

• Antibiotic-associated adverse events (AEs) within 7 days of completing antibiotics

  From index visit to 7 days of completing antibiotics

• Group A Strep Testing

  From start of implementation ramp up period to end of year 2 implementation

Study Arms (1)

CHOP Primary Care Providers

Providers at all 30 primary care practice offices and 4 urgent care offices that include physicians and Advanced Practice Provider (APPs) including Nurse Practitioners (NPs) and Physicians Assistants (PAs).

Other: Online Educational Modules; Other: Prescribing Feedback Reports; Other: Clinical Decision Support; Other: Live, hybrid in-person and online educational sessions

Interventions

Online Educational Modules OTHER

Online educational modules for clinicians that describe optimal antibiotic use and provide strategies to communicate with families about antibiotic prescribing for ARTIs. Modules are assigned through CHOP's internal learning website and assigned to every single primary care provider.

CHOP Primary Care Providers

Prescribing Feedback Reports OTHER

Prescribing feedback reports distributed quarterly that show clinicians how their prescribing and Group A Strep testing compares to their peers and to professional guideline recommendations. Will include metrics of overall prescribing and show choice and duration for antibiotics given ear infections, Strep throat, sinus infections, and pneumonia. The goal of the feedback reports is to show clinicians how often they are prescribing antibiotics, and when they do prescribe antibiotics are they doing so with right antibiotic and for the correct duration.

CHOP Primary Care Providers

Clinical Decision Support OTHER

Clinical decision support built into the electronic health record to help clinicians choose the right antibiotics for the right number of days. Using information from guidelines and clinical pathways created by CHOP to help providers continue to optimize their prescribing practices.

CHOP Primary Care Providers

Live, hybrid in-person and online educational sessions OTHER

Live, hybrid in-person and online educational sessions that explain the project, describe best prescribing practices and allow clinicians to talk directly with project team members. Study leaders visit all 31 practices across the network.

CHOP Primary Care Providers

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

In two years, the project team will reach all 121,000 children 6 months to 12 years of age seen at 288,000 encounters for ARTIs at the Primary Care Practices and Urgent Care locations across the CHOP primary care and urgent care network.

You may qualify if:

• Severe immunocompromised status OR tracheostomy dependence
• Children with other bacterial infection diagnoses

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia; Sinusitis; Otitis Media

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Paranasal Sinus Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Otitis; Ear Diseases

Study Officials

• Rebecca Same, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Louis Bell, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 15, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)