Broad Implementation of Outpatient Stewardship

NCT05127161 | Completed

• 1 other identifier: 21-018912
• Study Type: interventional
• Target: 1,032
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Pediatrics; Outpatient antibiotic stewardship; Broad-spectrum antibiotics

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  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.

Secondary Outcomes (7)

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

  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

  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

  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

  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

  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)

Study Arms (2)

Early Intervention

EXPERIMENTAL

The early intervention arm will begin receiving the intervention in study period 1.

Behavioral: Broad Implementation of Outpatient Stewardship (BIOS) intervention

Delayed Intervention (Control)

OTHER

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

Interventions

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.

Delayed Intervention (Control); Early Intervention

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

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

Study Sites (5)

Pediatric Associates

Plantation, Florida, 33324, United States

Location

Nationwide Children's Hospital

Cleveland, Ohio, 43205, United States

Location

MetroHealth

Cleveland, Ohio, 44109, United States

Location

Penn State Health

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Otitis Media; Pharyngitis

Interventions

Methods

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jeffrey Gerber, MD PhD MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 19, 2021
• Study Start: October 31, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)