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OpenTrials
Completed

NCT Number: NCT04219553

Antimicrobial Stewardship in Community Pharmacy

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.

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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shoppers Drug Mart #500, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antimicrobial stewardship

Behavioral

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.

Comparator (no intervention)

Other

No active intervention

Primary outcomes

  1. Change in guideline congruence

    Time frame: 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 outcomes

  1. Choice of antibiotic

    Time frame: Pre-post study intervention (comparison of two 4-6 month periods)

    % change in guideline congruence for choice of antibiotic before and after study intervention

  2. Antibiotic dosing

    Time frame: Pre-post study intervention (comparison of two 4-6 month periods)

    % change in guideline congruence for antibiotic dose before and after study intervention

  3. Antibiotic duration

    Time frame: Pre-post study intervention (comparison of two 4-6 month periods)

    % change in guideline congruence for antibiotic duration before and after study intervention

  4. Acceptance of pharmacist recommendations

    Time frame: 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)

  5. Balancing measure: resolution of AOM

    Time frame: 7-14 days after antibiotics were dispensed

    The percent of cases with symptom resolution for AOM

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2020
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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