Antimicrobial Stewardship in Community Pharmacy

Sponsor

University of Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT04219553

Collaborator

(none)

188

Enrollment

Locations

Arms

6.2

Actual Duration (Months)

Patients Per Site

15.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Otitis Media	Behavioral: Antimicrobial stewardship Other: Comparator (no intervention)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

188 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pre-post intervention study modelPre-post intervention study model

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 25, 2017

Actual Primary Completion Date :

Nov 15, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
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)
Balancing measure: resolution of AOM [7-14 days after antibiotics were dispensed]
The percent of cases with symptom resolution for AOM

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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