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Completed

NCT Number: NCT05127161

Broad Implementation of Outpatient Stewardship

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.

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Key information

Conditions

Acute Respiratory Tract Infection Acute Sinusitis Ear Diseases Infections Otitis Otitis Media Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Associates, Plantation, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinician inclusion criteria: Any non-trainee clinician who prescribes and provides care for children aged 6 months to 12 years with ARTIs and who is practicing at an included site. Clinicians will further be selected based on employment status at time of randomization and volume of prescribing over the past 12 months.
  • Visit inclusion criteria: visits made by patients of all participating practices aged 6 months through 12 years of age will be considered part of the project population.

Exclusion criteria

  • Clinician exclusion criteria: clinicians who are trainees, who do not prescribe (or prescribe very infrequently) to the patient population of interest, or who do not provide care for (or provide care very infrequently for) children aged 6 months to 12 years with ARTIs will be excluded
  • Visit exclusion criteria: visit by children with complex chronic conditions, as well as those treated with an antibiotic in the past 30 days, will have their data extracted but will be excluded from analyses

Treatment and study plan

Broad Implementation of Outpatient Stewardship (BIOS) intervention

Behavioral

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.

Primary outcomes

  1. Rate of broad-spectrum (off-guideline) antibiotic prescribing for all bacterial ARTIs

    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)

    The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed. Assessed using electronic health record data.

  2. Rate of antibiotic prescribing for all ARTIs (viral and bacterial)

    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)

    The proportion of visits for all ARTIs (viral and bacterial) during which an antibiotic was prescribed

  3. Engagement with intervention

    Time frame: Period 1 through period 3 (up to 40 months of intervention time following intervention initiation)

    Investigators will measure clinicians' completion rates of the educational modules and view rates of the feedback reports. Assessed through clinician attestation.

  4. Implementation of the intervention

    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.

    Investigators will use surveys and qualitative interviews to measure the extent to which the intervention was implemented as designed.

Secondary outcomes

  1. Rate of broad-spectrum (off-guideline) antibiotic prescribing by practice setting

    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)

    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.

  2. Rate of broad-spectrum (off-guideline) antibiotic prescribing by ARTI type

    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)

    The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by ARTI type. Assessed using electronic health record data.

  3. Rate of broad-spectrum (off-guideline) antibiotic prescribing by intervention participation status

    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)

    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.

  4. Rate of broad-spectrum (off-guideline) antibiotic prescribing by geographic location within each practice setting

    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)

    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.

  5. Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by practice setting

    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)

    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.

  6. Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by intervention participation status

    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)

    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.

  7. Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by geographic location within each practice setting

    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)

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • American Academy of Pediatrics
  • MetroHealth System, Ohio
  • Nationwide Children's Hospital
  • Patient-Centered Outcomes Research Institute
  • Pediatric Associates of Florida
  • Penn State Health
  • University of Pennsylvania

Registry information

Official study title

Broad Implementation of Outpatient Stewardship (BIOS) Project

Acronym: BIOS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2021
Registry last updated
Feb 9, 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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