Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1032 participants
INTERVENTIONAL
2022-10-31
2025-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Early Intervention
The early intervention arm will begin receiving the intervention in study period 1.
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.
Delayed Intervention (Control)
The delayed intervention (control) arm will begin receiving the intervention in study period 2. They will receive no intervention during period 1.
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.
Interventions
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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.
Eligibility Criteria
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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
6 Months
12 Years
ALL
Yes
Sponsors
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American Academy of Pediatrics
OTHER
University of Pennsylvania
OTHER
MetroHealth System, Ohio
OTHER
Penn State Health
UNKNOWN
Nationwide Children's Hospital
OTHER
Pediatric Associates of Florida
UNKNOWN
Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Gerber, MD PhD MSCE
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Pediatric Associates
Plantation, Florida, United States
Nationwide Children's Hospital
Cleveland, Ohio, United States
MetroHealth
Cleveland, Ohio, United States
Penn State Health
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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21-018912
Identifier Type: -
Identifier Source: org_study_id
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