Broad Implementation of Outpatient Stewardship

Otitis Media Clinical Trial

— BIOS  

Official title:

Broad Implementation of Outpatient Stewardship (BIOS) Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05127161
• Other study ID #: 21-018912
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: April 21, 2025

Study information

• Verified date: January 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1032
• Est. completion date: April 21, 2025
• Est. primary completion date: April 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	MetroHealth	Cleveland	Ohio
United States	Nationwide Children's Hospital	Cleveland	Ohio
United States	Penn State Health	Hershey	Pennsylvania
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Pediatric Associates	Plantation	Florida

Sponsors (8)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	American Academy of Pediatrics, Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute, Pediatric Associates of Florida, Penn State Health, The MetroHealth System, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 27 months of intervention time following intervention initiation)
Primary	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 27 months of intervention time following intervention initiation)
Primary	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 27 months of intervention time following intervention initiation)
Primary	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.
Secondary	Rate of broad-spectrum (off-guideline) antibiotic prescribing by practice setting	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.	from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)
Secondary	Rate of broad-spectrum (off-guideline) antibiotic prescribing by ARTI type	The proportion of visits for bacterial ARTIs during which a broad-spectrum antibiotic was prescribed by ARTI type. Assessed using electronic health record data.	from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)
Secondary	Rate of broad-spectrum (off-guideline) antibiotic prescribing by intervention participation status	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.	from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)
Secondary	Rate of broad-spectrum (off-guideline) antibiotic prescribing by geographic location within each practice setting	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.	from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)
Secondary	Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by practice setting	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.	from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)
Secondary	Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by intervention participation status	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.	from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)
Secondary	Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by geographic location within each practice setting	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.	from baseline (up to 36 months prior to randomization) through each of the study periods (up to 27 months of intervention time following intervention initiation)