NCT05127161

Broad Implementation of Outpatient Stewardship

Broad Implementation of Outpatient Stewardship (BIOS) Project

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,032 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Acute Respiratory Tract Infection
• Otitis Media
• Pharyngitis
• Acute Sinusitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-31
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-11-19
• Last updated: 2026-02-09

Locations

5 sites across 1 country: United States