An interventional study of Broad Implementation of Outpatient Stewardship (BIOS) intervention in Acute Respiratory Tract Infection, Otitis Media and Pharyngitis, sponsored by Children's Hospital of Philadelphia. Completed at 5 sites in United States. Open to participants aged 6 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research
Reducing inappropriate antibiotic use is a key strategy to mitigate antibiotic resistance and adverse health effects associated with antibiotic exposure. The Broad Implementation of Outpatient Stewardship (BIOS) project focuses on broadly implementing an evidence-based intervention to improve antibiotic prescribing for acute respiratory tract infections in pediatric outpatient settings. Primary aims include: (1) examining the acceptability, feasibility and utility of a focused implementation strategy on improving intervention adoption and impact and (2) measuring the effectiveness of the intervention to reduce unnecessary broad-spectrum antibiotic prescription.
Antibiotics are commonly prescribed for acute respiratory tract infections (ARTIs) in pediatric outpatient settings, but up to half of antibiotic use is inappropriate. Prior work demonstrated broad-spectrum antibiotics did not improve patient health outcomes compared to narrow-spectrum antibiotics, but did increase harmful side effects. Overuse of broad-spectrum antibiotics can exacerbate antibiotic resistance and drug-related adverse events. Certain interventions have been effective in improving antibiotic prescribing, but none have been implemented widely.
The BIOS project focuses on broadly implementing an evidence-based intervention to improve how clinicians in outpatient settings prescribe antibiotics for ARTIs in children 6 months to 12 years old. The intervention consists of educational modules and prescribing audit and feedback reports delivered to clinicians in a variety of outpatient settings across 5 health systems.
Primary aims include: (1) examining the acceptability, feasibility and utility of a focused implementation strategy on improving intervention adoption and impact and (2) measuring the effectiveness of the intervention to reduce unnecessary broad-spectrum antibiotic prescription.
Clinicians will be randomized to one of two arms: an early intervention arm or a delayed intervention (control) arm. The study will use a 4-period design, where the periods are as follows:
Period 0: Baseline period that occurs prior to randomization
Period 1: clinicians in the early intervention arm receive the intervention
Period 2: All clinicians (both arms) receive the intervention
Period 3: Maintenance period, external support from the study team is removed
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's enrollment of 1,032 is above the median of 165 across 174 interventional studies indexed under Otitis Media.
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Exclusion Criteria:
The early intervention arm will begin receiving the intervention in study period 1.
Behavioral: Broad Implementation of Outpatient Stewardship (BIOS) intervention
The delayed intervention (control) arm will begin receiving the intervention in study period 2. They will receive no intervention during period 1.
Behavioral: Broad Implementation of Outpatient Stewardship (BIOS) intervention
The BIOS intervention consists of 3 components: (1) online educational modules covering topics related to appropriate antibiotic prescribing for ARTIs, (2) individualized audit and feedback reports displaying clinicians' rates of antibiotic prescription with peer comparison, (3) facilitation provided by the study team and by health system champions to support effective implementation of the intervention and to encourage clinicians to engage meaningfully in the intervention activities.
Rate of broad-spectrum (off-guideline) antibiotic prescribing for all bacterial ARTIs
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed. Assessed using electronic health record data.
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial)
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Engagement with intervention
Investigators will measure clinicians' completion rates of the educational modules and view rates of the feedback reports. Assessed through clinician attestation.
Time frame: Period 1 through period 3 (up to 40 months of intervention time following intervention initiation)
Implementation of the intervention
Investigators will use surveys and qualitative interviews to measure the extent to which the intervention was implemented as designed.
Time frame: Surveys administered at the start of or just prior to period 1, during period 2, and during period 3. Interviews conducted during period 2 and period 3.
Rate of broad-spectrum (off-guideline) antibiotic prescribing by practice setting
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by practice setting (Emergency department, urgent care, pediatric primary care, family medicine/medicine-pediatrics). Assessed using electronic health record data.
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by ARTI type
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by ARTI type. Assessed using electronic health record data.
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by intervention participation status
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by whether clinicians attested to completing study activities. Assessed using electronic health record data.
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of broad-spectrum (off-guideline) antibiotic prescribing by geographic location within each practice setting
The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by geographic location within each practice setting (Emergency department, urgent care, pediatric primary care, family medicine/medicine-pediatrics). Assessed using electronic health record data.
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by practice setting
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed by practice setting (Emergency department, urgent care, pediatric primary care, family medicine/medicine-pediatrics). Assessed using electronic health record data.
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by intervention participation status
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed by whether clinicians attested to completing study activities. Assessed using electronic health record data.
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by geographic location within each practice setting
The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed by geographic location within each practice setting (Emergency department, urgent care, pediatric primary care, family medicine/medicine-pediatrics). Assessed using electronic health record data.
Time frame: from baseline (up to 36 months prior to randomization) through each of the study periods (up to 40 months of intervention time following intervention initiation)
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