Antimicrobial Stewardship in Community Pharmacy

January 4, 2020 updated by: Katherine Koroluk, University of Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4C 1H6
        • Shoppers Drug Mart #500
      • Toronto, Ontario, Canada, M4J 1L2
        • Shoppers Drug Mart #994

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Retrospective group
Comparator group (pre-intervention)
Other: Comparator (no intervention)
No active intervention
Experimental: Prospective group
Study group (post-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-post study intervention (comparison of two 4-6 month periods)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-post study intervention (comparison of two 4-6 month periods)
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
Pre-post study intervention (comparison of two 4-6 month periods)
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
Pre-post study intervention (comparison of two 4-6 month periods)
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)
Post-intervention study arm (6 month period after start of intervention)
Balancing measure: resolution of AOM
Time Frame: 7-14 days after antibiotics were dispensed
The percent of cases with symptom resolution for AOM
7-14 days after antibiotics were dispensed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2017

Primary Completion (Actual)

November 15, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 5, 2017

First Submitted That Met QC Criteria

January 4, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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