Antimicrobial Stewardship in Community Pharmacy

Otitis Media Clinical Trial

Official title:

Moving Antimicrobial Stewardship Into Community Pharmacy: A Pre-post Study of Acute Otitis Media Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04219553
• Other study ID #: 34327
• Status: Completed
• Phase: N/A
• Start date: May 25, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2020
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: December 1, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Behavioral:
• Antimicrobial stewardship
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.

Other:
• Comparator (no intervention)
No active intervention

Locations

Country	Name	City	State
Canada	Shoppers Drug Mart #500	Toronto	Ontario
Canada	Shoppers Drug Mart #994	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in guideline congruence	% change in guideline congruence for overall antibiotic prescriptions as attributable to pharmacist intervention before and after study intervention	Pre-post study intervention (comparison of two 4-6 month periods)
Secondary	Choice of antibiotic	% change in guideline congruence for choice of antibiotic before and after study intervention	Pre-post study intervention (comparison of two 4-6 month periods)
Secondary	Antibiotic dosing	% change in guideline congruence for antibiotic dose before and after study intervention	Pre-post study intervention (comparison of two 4-6 month periods)
Secondary	Antibiotic duration	% change in guideline congruence for antibiotic duration before and after study intervention	Pre-post study intervention (comparison of two 4-6 month periods)
Secondary	Acceptance of pharmacist recommendations	The percentage of pharmacist recommendations that were accepted by prescribers and parents/guardians (descriptive statistic)	Post-intervention study arm (6 month period after start of intervention)
Secondary	Balancing measure: resolution of AOM	The percent of cases with symptom resolution for AOM	7-14 days after antibiotics were dispensed