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| Name | Class |
|---|---|
| American Academy of Pediatrics | OTHER |
| University of Pennsylvania | OTHER |
| MetroHealth System, Ohio | OTHER |
| Penn State Health |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Intervention | Experimental | The early intervention arm will begin receiving the intervention in study period 1. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 40 months of intervention time following intervention initiation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Gerber, MD PhD MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Associates | Plantation | Florida | 33324 | United States | ||
| Nationwide Children's Hospital |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| UNKNOWN |
| Nationwide Children's Hospital | OTHER |
| Pediatric Associates of Florida | UNKNOWN |
| Patient-Centered Outcomes Research Institute | OTHER |
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|
| 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 40 months of intervention time following intervention initiation) |
| 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 40 months of intervention time following intervention initiation) |
| 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 40 months of intervention time following intervention initiation) |
| 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 40 months of intervention time following intervention initiation) |
| 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 40 months of intervention time following intervention initiation) |
| 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 40 months of intervention time following intervention initiation) |
| Cleveland |
| Ohio |
| 43205 |
| United States |
| MetroHealth | Cleveland | Ohio | 44109 | United States |
| Penn State Health | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| D007239 |
| Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |