Back to resultsAntimicrobial Stewardship in Community Pharmacy
Primary Purpose
Otitis Media
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Antimicrobial stewardship
Comparator (no intervention)
Sponsored by
About this trial
This is an interventional other trial for Otitis Media focused on measuring antimicrobial stewardship, pharmacies, community pharmacy services, anti-infective agents, drug utilization
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
Sites / Locations
- Shoppers Drug Mart #500
- Shoppers Drug Mart #994
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Retrospective group
Prospective group
Arm Description
Comparator group (pre-intervention)
Study group (post-intervention)
Outcomes
Primary Outcome Measures
Change in guideline congruence
% change in guideline congruence for overall antibiotic prescriptions as attributable to pharmacist intervention before and after study intervention
Secondary Outcome Measures
Choice of antibiotic
% change in guideline congruence for choice of antibiotic before and after study intervention
Antibiotic dosing
% change in guideline congruence for antibiotic dose before and after study intervention
Antibiotic duration
% change in guideline congruence for antibiotic duration before and after study intervention
Acceptance of pharmacist recommendations
The percentage of pharmacist recommendations that were accepted by prescribers and parents/guardians (descriptive statistic)
Balancing measure: resolution of AOM
The percent of cases with symptom resolution for AOM
Full Information
NCT ID
NCT04219553
First Posted
November 5, 2017
Last Updated
January 4, 2020
Sponsor
University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04219553
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
antimicrobial stewardship, pharmacies, community pharmacy services, anti-infective agents, drug utilization
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post intervention study model
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retrospective group
Arm Type
Other
Arm Description
Comparator group (pre-intervention)
Arm Title
Prospective group
Arm Type
Experimental
Arm Description
Study group (post-intervention)
Intervention Type
Behavioral
Intervention Name(s)
Antimicrobial stewardship
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Comparator (no intervention)
Intervention Description
No active intervention
Primary Outcome Measure Information:
Title
Change in guideline congruence
Description
% change in guideline congruence for overall antibiotic prescriptions as attributable to pharmacist intervention before and after study intervention
Time Frame
Pre-post study intervention (comparison of two 4-6 month periods)
Secondary Outcome Measure Information:
Title
Choice of antibiotic
Description
% change in guideline congruence for choice of antibiotic before and after study intervention
Time Frame
Pre-post study intervention (comparison of two 4-6 month periods)
Title
Antibiotic dosing
Description
% change in guideline congruence for antibiotic dose before and after study intervention
Time Frame
Pre-post study intervention (comparison of two 4-6 month periods)
Title
Antibiotic duration
Description
% change in guideline congruence for antibiotic duration before and after study intervention
Time Frame
Pre-post study intervention (comparison of two 4-6 month periods)
Title
Acceptance of pharmacist recommendations
Description
The percentage of pharmacist recommendations that were accepted by prescribers and parents/guardians (descriptive statistic)
Time Frame
Post-intervention study arm (6 month period after start of intervention)
Title
Balancing measure: resolution of AOM
Description
The percent of cases with symptom resolution for AOM
Time Frame
7-14 days after antibiotics were dispensed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shoppers Drug Mart #500
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 1H6
Country
Canada
Facility Name
Shoppers Drug Mart #994
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4J 1L2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Antimicrobial Stewardship in Community Pharmacy
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