Antimicrobial Stewardship in Community Pharmacy
- Conditions
- Otitis Media
- Interventions
- Other: Comparator (no intervention)Behavioral: Antimicrobial stewardship
- Registration Number
- NCT04219553
- Lead Sponsor
- University of Toronto
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Retrospective group Comparator (no intervention) Comparator group (pre-intervention) Prospective group Antimicrobial stewardship Study group (post-intervention)
- Primary Outcome Measures
Name Time Method Change in guideline congruence Pre-post study intervention (comparison of two 4-6 month periods) % change in guideline congruence for overall antibiotic prescriptions as attributable to pharmacist intervention before and after study intervention
- Secondary Outcome Measures
Name Time Method Antibiotic dosing Pre-post study intervention (comparison of two 4-6 month periods) % change in guideline congruence for antibiotic dose before and after study intervention
Antibiotic duration Pre-post study intervention (comparison of two 4-6 month periods) % change in guideline congruence for antibiotic duration before and after study intervention
Acceptance of pharmacist recommendations Post-intervention study arm (6 month period after start of intervention) The percentage of pharmacist recommendations that were accepted by prescribers and parents/guardians (descriptive statistic)
Choice of antibiotic Pre-post study intervention (comparison of two 4-6 month periods) % change in guideline congruence for choice of antibiotic before and after study intervention
Balancing measure: resolution of AOM 7-14 days after antibiotics were dispensed The percent of cases with symptom resolution for AOM
Trial Locations
- Locations (2)
Shoppers Drug Mart #500
🇨🇦Toronto, Ontario, Canada
Shoppers Drug Mart #994
🇨🇦Toronto, Ontario, Canada