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Broad Implementation of Outpatient Stewardship

NCT05127161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1032

Last updated 2026-02-09

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Gerber, MD PhD MSCE · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05127161 on ClinicalTrials.gov