Otitis MediaNCT04219553
Antimicrobial Stewardship in Community Pharmacy
A study testing Antimicrobial stewardship in people with Otitis Media, run by University of Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- Antimicrobial stewardship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesCanada
- Study dates
- 25 May 2017to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Shoppers Drug Mart #500
Toronto, Ontario, M4C 1H6
Shoppers Drug Mart #994
Toronto, Ontario, M4J 1L2
About this study
Official title: 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.
- Conditions
- Otitis Media
- Being tested
- Antimicrobial stewardship, Comparator (no intervention)
- Keywords
- antimicrobial stewardship, pharmacies, community pharmacy services, anti-infective agents, drug utilization
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial stewardshipBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Retrospective group | Other | Comparator group (pre-intervention) Receives: Other: Comparator (no intervention) |
| Prospective group | Experimental | Study group (post-intervention) Receives: Behavioral: Antimicrobial stewardship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in guideline congruence
% change in guideline congruence for overall antibiotic prescriptions as attributable to pharmacist intervention before and after study intervention
Measured: Pre-post study intervention (comparison of two 4-6 month periods)
Secondary outcomes (5)
Choice of antibiotic
% change in guideline congruence for choice of antibiotic before and after study intervention
Measured: Pre-post study intervention (comparison of two 4-6 month periods)
Antibiotic dosing
% change in guideline congruence for antibiotic dose before and after study intervention
Measured: Pre-post study intervention (comparison of two 4-6 month periods)
Antibiotic duration
% change in guideline congruence for antibiotic duration before and after study intervention
Measured: Pre-post study intervention (comparison of two 4-6 month periods)
Acceptance of pharmacist recommendations
The percentage of pharmacist recommendations that were accepted by prescribers and parents/guardians (descriptive statistic)
Measured: Post-intervention study arm (6 month period after start of intervention)
Balancing measure: resolution of AOM
The percent of cases with symptom resolution for AOM
Measured: 7-14 days after antibiotics were dispensed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start25 May 2017
- Primary completion15 Nov 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Pre-post intervention study model
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Koroluk, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219553
- Sponsor's protocol ID
- 34327
- Status last verified
- Jan 2020
- First submitted
- 5 Nov 2017
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving Antimicrobial Stewardship Into Community Pharmacy: A Pre-post Study of Acute Otitis Media Management
- ClinicalTrials.gov ID
- NCT04219553
- Acronym / sponsor ID
- 34327
- Conditions
- Otitis Media
- Keywords
- antimicrobial stewardship, pharmacies, community pharmacy services, anti-infective agents, drug utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-post intervention study model
| Arm | Type | Receives |
|---|---|---|
| Retrospective group | Other | Other: Comparator (no intervention)Comparator group (pre-intervention) |
| Prospective group | Experimental | Behavioral: Antimicrobial stewardshipStudy group (post-intervention) |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial stewardshipThe multifaceted AMS intervention includes pharmacist education, a clinical decision support tool, a parent/guardian questionnaire, and individualized monthly audit and feedback with each pharmacist. | Behavioural | Prospective group |
| Comparator (no intervention)No active intervention | Other | Retrospective group |
Primary outcome
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
5 secondary outcomes
Choice of antibiotic
Time frame: 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)
Antibiotic duration
Time frame: 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)
Balancing measure: resolution of AOM
Time frame: 7-14 days after antibiotics were dispensed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial stewardship in people with Otitis Media, run by University of Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in guideline congruence (time frame: Pre-post study intervention (comparison of two 4-6 month periods)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.