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 range

6 Months – 12 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

6 Months – 12 Years

Sex

ALL

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.