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NCT Number: NCT07217002

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Community Acquired Pneumonia (CAP) Acute Otitis Media (AOM) Community-Acquired Infections Community-Acquired Pneumonia Ear Diseases Infections Nose Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Sinusitis Strep Pharyngitis

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

Children often receive antibiotics for acute respiratory tract infections (ARTIs) which are caused by viruses, such as the common cold. However, antibiotics cannot treat viruses. Using antibiotics when they are not needed can cause harm - including side effects like rashes, vomiting and diarrhea - and can make it harder for the antibiotics to work when they are needed to treat infections caused by bacteria. For ARTIs caused by bacteria - like ear infections, sinus infections, strep throat or pneumonia - narrow-spectrum antibiotics are the best choice. This is because narrow-spectrum antibiotics target only the harmful bacteria, while "broad-spectrum" antibiotics target additional bacteria than can be helpful for the body. For many of these infections, it is also better to use shorter courses of antibiotics (such as five days) instead of longer courses (such as 10 days). Research studies have shown clearly that shorter courses and narrow-spectrum antibiotics cure infections just as well as longer courses and broad-spectrum antibiotics, but with fewer side effects.

Over two years, the project team will use proven strategies to ensure that children get the right antibiotics for the right amount of time. During this time, all pediatric doctors and nurse practitioners in this large, diverse network will receive:

  • Online education about proper antibiotic prescribing.
  • Regular feedback on how their antibiotic prescribing and group A strep testing compares to their peers and to professional guidelines.
  • Tools in the electronic health record to make it easy to prescribe the right antibiotics.
  • Yearly, live hybrid in-person and online educational sessions

The project team will determine how well this program works by measuring:

  • How often antibiotics are prescribed to children with ARTIs.
  • How often children with bacterial ARTIs (ear infections, sinus infections, strep throat and pneumonia) get the right antibiotic choice and right number of antibiotic days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion

  • All children ages 6 months to 12 years seen at CHOP primary care network and CHOP Urgent Care with ARTI diagnoses (viral diagnoses or AOM, CAP, sinusitis, strep pharyngitis) Exclusion
  • Severe immunocompromised status OR tracheostomy dependence
  • Children with other bacterial infection diagnoses

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Antibiotic Prescribing Rates for Acute Respiratory Tract Infections (ARTIs)

    Time frame: From start of implementation ramp up period to end of year 2 implementation

    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.

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

    Time frame: From start of implementation ramp up period to end of year 2 implementation

    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

  3. Broad- versus Narrow-Spectrum Antibiotic Prescribing

    Time frame: From start of implementation ramp up period to end of year 2 implementation

    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.

  4. Shortest Effective Duration Antibiotic Prescribing

    Time frame: From start of implementation ramp up period to end of year 2 implementation

    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.

Secondary outcomes

  1. Treatment failure or modification 14 days

    Time frame: 14 days

    Treatment failure measured at 14 days if there is in person or telephone contact with the same ARTI diagnosis with receipt of any systemic ARTI-directed antibiotic found in the EHR. The target is for no increase in treatment failure.

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

    Time frame: From index visit to 7 days of completing antibiotics

    AEs as measured by in person or telephone contact for diarrhea, candidiasis, non-candidal rash, other or unspecified allergic reaction, other or unspecified adverse event, and vomiting using the EHR.

  3. Group A Strep Testing

    Time frame: From start of implementation ramp up period to end of year 2 implementation

    Proportion of ARTI visits with a Group A Strep Test.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: RAISIN

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 15, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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