CompletedNot Applicable

Broad Implementation of Outpatient Stewardship

United States1,032 participantsStarted 2022-10-31

Plain-language 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.

Who can participate

Age range6 Months – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

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)

Engagement with intervention

Timeframe: Period 1 through period 3 (up to 40 months of intervention time following intervention initiation)

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.

Trial details

NCT IDNCT05127161

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Acute Respiratory Tract Infection trials

Plain-language summary

Who can participate

Age range6 Months – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)

Engagement with intervention

Timeframe: Period 1 through period 3 (up to 40 months of intervention time following intervention initiation)

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.