NCT04219553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2017

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

November 5, 2017

Last Update Submit

January 4, 2020

Conditions

Otitis Media

Keywords

antimicrobial stewardshippharmaciescommunity pharmacy servicesanti-infective agentsdrug utilization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Choice of antibiotic

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

  • Antibiotic dosing

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

  • Antibiotic duration

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

  • Acceptance of pharmacist recommendations

    Post-intervention study arm (6 month period after start of intervention)

  • Balancing measure: resolution of AOM

    7-14 days after antibiotics were dispensed

Study Arms (2)

Retrospective group

OTHER

Comparator group (pre-intervention)

Other: Comparator (no intervention)

Prospective group

EXPERIMENTAL

Study group (post-intervention)

Behavioral: Antimicrobial stewardship

Interventions

Antimicrobial stewardshipBEHAVIORAL

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.

Prospective group
Comparator (no intervention)OTHER

No active intervention

Retrospective group

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shoppers Drug Mart #500

Toronto, Ontario, M4C 1H6, Canada

Location

Shoppers Drug Mart #994

Toronto, Ontario, M4J 1L2, Canada

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Antimicrobial Stewardship

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Drug Utilization ReviewDrug UtilizationPharmacy AdministrationOrganization and AdministrationHealth Services AdministrationUtilization ReviewQuality of Health CareQuality Assurance, Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pre-post intervention study model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2017

First Posted

January 7, 2020

Study Start

May 25, 2017

Primary Completion

November 15, 2017

Study Completion

December 1, 2017

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

CA(2)