Clinical trial NCT05127161: Broad Implementation of Outpatient Stewardship
Official title: Broad Implementation of Outpatient Stewardship (BIOS) Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Respiratory Tract Infection
Otitis Media
Pharyngitis
Acute Sinusitis
Keywords: Pediatrics
Outpatient antibiotic stewardship
Broad-spectrum antibiotics
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: University of Pennsylvania
name: MetroHealth System, Ohio
name: Penn State Health
name: Nationwide Children's Hospital
name: Pediatric Associates of Florida
name: Patient-Centered Outcomes Research Institute
First posted: 2021-11-19
Enrollment: 1032
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of broad-spectrum (off-guideline) antibiotic prescribing for all bacterial ARTIs
timeFrame: 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)
measure: Rate of antibiotic prescribing for all ARTIs (viral and bacterial)
timeFrame: 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)
measure: Engagement with intervention
timeFrame: Period 1 through period 3 (up to 40 months of intervention time following intervention initiation)
measure: Implementation of the intervention
timeFrame: 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:
measure: Rate of broad-spectrum (off-guideline) antibiotic prescribing by practice setting
timeFrame: 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)
measure: Rate of broad-spectrum (off-guideline) antibiotic prescribing by ARTI type
timeFrame: 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)
measure: Rate of broad-spectrum (off-guideline) antibiotic prescribing by intervention participation status
timeFrame: 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)
measure: Rate of broad-spectrum (off-guideline) antibiotic prescribing by geographic location within each practice setting
timeFrame: 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)
measure: Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by practice setting
timeFrame: 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)
measure: Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by intervention participation status
timeFrame: 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)
measure: Rate of antibiotic prescribing for all ARTIs (viral and bacterial) by geographic location within each practice setting
timeFrame: 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)
Other outcomes:
Locations:
city: Plantation
country: United States
facility: Pediatric Associates
state: Florida
city: Cleveland
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jeffrey Gerber, MD PhD MSCE
role: PRINCIPAL_INVESTIGATOR
References: