Clinical trial NCT04219553: Antimicrobial Stewardship in Community Pharmacy
Official title: Moving Antimicrobial Stewardship Into Community Pharmacy: A Pre-post Study of Acute Otitis Media Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Keywords: antimicrobial stewardship
pharmacies
community pharmacy services
anti-infective agents
drug utilization
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 188
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post intervention study model
Primary purpose: OTHER

Brief summary: Acute otitis media (AOM) is the most common indication for antibiotics for Canadian paediatric patients. As the gatekeepers of safe and effective prescription pharmacotherapy, community pharmacists are well positioned to influence and optimize antibiotic use. The purpose of this project is to develop, implement, and evaluate an antimicrobial stewardship program in the community pharmacy setting that aims to optimize antibiotic use for AOM. This nonrandomized pre-post study includes children aged 6 months to 12 years presenting with an antibiotic prescription for AOM at two community pharmacies in Toronto, Ontario. Participants are excluded if they exhibit signs/symptoms of mastoiditis, have an additional indication for systemic antibiotics, or parents/guardians cannot consent in English. The multifaceted AMS intervention includes pharmacist education, a clinical decision support tool, a parent/guardian questionnaire, and individualized monthly audit and feedback with each pharmacist. Prescriptions are reviewed and adapted by the pharmacist to optimize congruence with 2016 Canadian Paediatric Society AOM guidelines. The primary outcome is the percentage change in guideline congruence attributable to pharmacist intervention. This study will provide insight into the opportunities and barriers of developing large-scale antimicrobial stewardship programs for community pharmacies.


Eligibility criteria: Inclusion Criteria:

* Prescribed systemic oral antibiotic therapy
* Antibiotics are indicated for the treatment of acute otitis media (AOM) as reported verbally or in writing by parent/guardian or prescriber

Exclusion Criteria:

* signs/symptoms of mastoiditis
* a diagnosis in addition to AOM for which systemic antibiotics are indicated
* parents/guardians cannot consent to the study in English

Primary outcomes:
measure: Change in guideline congruence
timeFrame: Pre-post study intervention (comparison of two 4-6 month periods)
Secondary outcomes:
measure: Choice of antibiotic
timeFrame: Pre-post study intervention (comparison of two 4-6 month periods)
measure: Antibiotic dosing
timeFrame: Pre-post study intervention (comparison of two 4-6 month periods)
measure: Antibiotic duration
timeFrame: Pre-post study intervention (comparison of two 4-6 month periods)
measure: Acceptance of pharmacist recommendations
timeFrame: Post-intervention study arm (6 month period after start of intervention)
measure: Balancing measure: resolution of AOM
timeFrame: 7-14 days after antibiotics were dispensed
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Shoppers Drug Mart #500
state: Ontario
city: Toronto
country: Canada
facility: Shoppers Drug Mart #994
state: Ontario
Study officials:
References: