Upper Respiratory Tract InfectionsNCT05557214
Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
A study testing Audit and Feedback Letter in people with Upper Respiratory Tract Infections, run by Saskatchewan Health Authority - Regina Area.
Trial summary
Approximately 90% of antibiotics are prescribed in primary healthcare (PHC) in Canada (Public Health Agency of Canada, 2020), making this an important sector for antimicrobial stewardship. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- Audit and Feedback Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2023to May 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- must be a practicing family physician in Saskatchewan
- top 25th percentile of antimicrobial prescribers
Who cannot join
- fewer than 12 months of historical prescribing data available
About this study
Approximately 90% of antibiotics are prescribed in primary healthcare (PHC) in Canada (Public Health Agency of Canada, 2020), making this an important sector for antimicrobial stewardship. Upper respiratory tract infections (URTIs) represent a common indication in PHC for which antibiotics are often prescribed unnecessarily (Leis et al, 2020; Schwartz et al., 2020). Reducing unnecessary antibiotic treatment in this sector is a vital part of contributing to minimizing the global burden of antibiotic resistance.
The goal of this research project is to reduce the number of antibiotic prescriptions among family physicians identified as high prescribers in Saskatchewan. To achieve this, the investigators will send letters to the top 25th percentile of high prescribers in PHC. The letters will contain data indicating the prescribers high antimicrobial usage as well as guidance for reducing unnecessary prescriptions and promoting appropriate lengths of prescriptions for upper respiratory tract infections.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- Audit and Feedback Letter
- Keywords
- audit and feedback, antimicrobials, primary healthcare
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and Feedback LetterBehavioural
Physicians in the Audit and Feedback Letter Arm will receive an initial letter indicating their high prescriber status with guidance on reducing unnecessary antimicrobial use. They will also receive a follow-up letter at the 6 month mark indicating any change in prescribing habits. There will be a study closure letter mailed at the 12 month mark.
| Study group | Role | What they receive |
|---|---|---|
| Audit and Feedback Letter | Experimental | This group will receive 2 audit and feedback letters and a study closure letter. Receives: Behavioral: Audit and Feedback Letter |
| No Audit and Feedback Letter | No intervention | This group will only receive a study closure letter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Antibiotic Prescriptions
Total number of antibiotic prescriptions compared to covariate-adjusted baseline number of prescriptions prior to the intervention.
Measured: 12 months
Secondary outcomes (4)
Total Prolonged-Duration Prescription
Number of prescriptions longer than 7 days.
Measured: 12 months
Total Days of Therapy
Number of days of therapy of antimicrobials for each provider.
Measured: 12 months
Antibiotic Cost
Total cost of prescribed antibiotics.
Measured: 12 months
Total Specific Antibiotic Prescriptions
Number of prescriptions for specific antibiotics.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Why it stopped: Unable to execute data sharing agreement with Ministry of Health.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Vanstone, Saskatchewan Health Authority - Regina Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557214
- Sponsor's protocol ID
- REB-22-38
- Status last verified
- Apr 2023
- First submitted
- 22 Sep 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified aggregate data will be shared via a published manuscript at the conclusion of the study.
Publications
Leis JA, Born KB, Ostrow O, Moser A, Grill A. Prescriber-led practice changes that can bolster antimicrobial stewardship in community health care settings. Can Commun Dis Rep. 2020 Jan 2;46(1):1-5. doi: 10.14745/ccdr.v46i01a01. eCollection 2020 Jan 2.
PubMed 31930218Schwartz KL, Langford BJ, Daneman N, Chen B, Brown KA, McIsaac W, Tu K, Candido E, Johnstone J, Leung V, Hwee J, Silverman M, Wu JHC, Garber G. Unnecessary antibiotic prescribing in a Canadian primary care setting: a descriptive analysis using routinely collected electronic medical record data. CMAJ Open. 2020 May 7;8(2):E360-E369. doi: 10.9778/cmajo.20190175. Print 2020 Apr-Jun.
PubMed 32381687
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
- ClinicalTrials.gov ID
- NCT05557214
- Acronym / sponsor ID
- REB-22-38
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- audit and feedback, antimicrobials, primary healthcare
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to execute data sharing agreement with Ministry of Health.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saskatchewan Health Authority - Regina AreaUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 27 Sep 2022 (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.
Approximately 90% of antibiotics are prescribed in primary healthcare (PHC) in Canada (Public Health Agency of Canada, 2020), making this an important sector for antimicrobial stewardship. Upper respiratory tract infections (URTIs) represent a common indication in PHC for which antibiotics are often prescribed unnecessarily (Leis et al, 2020; Schwartz et al., 2020). Reducing unnecessary antibiotic treatment in this sector is a vital part of contributing to minimizing the global burden of antibiotic resistance.
The goal of this research project is to reduce the number of antibiotic prescriptions among family physicians identified as high prescribers in Saskatchewan. To achieve this, the investigators will send letters to the top 25th percentile of high prescribers in PHC. The letters will contain data indicating the prescribers high antimicrobial usage as well as guidance for reducing unnecessary prescriptions and promoting appropriate lengths of prescriptions for upper respiratory tract infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audit and Feedback Letter | Experimental | Behavioral: Audit and Feedback LetterThis group will receive 2 audit and feedback letters and a study closure letter. |
| No Audit and Feedback Letter | No intervention | –This group will only receive a study closure letter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- must be a practicing family physician in Saskatchewan
- top 25th percentile of antimicrobial prescribers
Key exclusion criteria (1 listed)
- fewer than 12 months of historical prescribing data available
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 |
|---|---|---|
| Audit and Feedback LetterPhysicians in the Audit and Feedback Letter Arm will receive an initial letter indicating their high prescriber status with guidance on reducing unnecessary antimicrobial use. They will also receive a follow-up letter at the 6 month mark indicating any change in prescribing habits. There will be a study closure letter mailed at the 12 month mark. | Behavioural | Audit and Feedback Letter |
Primary outcome
Total Antibiotic Prescriptions
Time frame: 12 months
Total number of antibiotic prescriptions compared to covariate-adjusted baseline number of prescriptions prior to the intervention.
4 secondary outcomes
Total Prolonged-Duration Prescription
Time frame: 12 months
Total Days of Therapy
Time frame: 12 months
Antibiotic Cost
Time frame: 12 months
Total Specific Antibiotic Prescriptions
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 31930218Leis JA, Born KB, Ostrow O, Moser A, Grill A. Prescriber-led practice changes that can bolster antimicrobial stewardship in community health care settings. Can Commun Dis Rep. 2020 Jan 2;46(1):1-5. doi: 10.14745/ccdr.v46i01a01. eCollection 2020 Jan 2.
- Background: PubMed 32381687Schwartz KL, Langford BJ, Daneman N, Chen B, Brown KA, McIsaac W, Tu K, Candido E, Johnstone J, Leung V, Hwee J, Silverman M, Wu JHC, Garber G. Unnecessary antibiotic prescribing in a Canadian primary care setting: a descriptive analysis using routinely collected electronic medical record data. CMAJ Open. 2020 May 7;8(2):E360-E369. doi: 10.9778/cmajo.20190175. Print 2020 Apr-Jun.
- Individual participant dataSharing planned: No. Deidentified aggregate data will be shared via a published manuscript at the conclusion of the study.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Feedback Letter in people with Upper Respiratory Tract Infections, run by Saskatchewan Health Authority - Regina Area.
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 1 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: withdrawn, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Total Antibiotic Prescriptions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557214, which also lists 2 linked publications.
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 13 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.