InfectionNCT05044052
Does Inclusion of Viral Prescription Pad Resources Increase Responsiveness to Feedback About Antibiotic Prescribing in Primary Care
A study testing Emphasis on the Choosing Wisely Viral Prescription Pad in people with Infection, run by Women's College Hospital at 1 site in Canada.
Trial summary
Antibiotic overuse is common and antibiotic prescribing contributes to rising rates of antimicrobial resistance. Primary care physicians prescribe the majority of all antibiotics and there is large inter-physician variability in prescribing that cannot be explained by differences in patient populations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection
- What is being tested?
- Emphasis on the Choosing Wisely Viral Prescription Pad
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,379 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2021to 15 Dec 2022
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Family physicians who sign up for the MyPractice reports by September 2021
Who cannot join
- Family physicians who did not sign up for the MyPractice reports by September 2021
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Peer-comparisons, Emphasis on Harms, and/or Inclusion of Viral Prescription Pad Resources Increase Responsiveness to Feedback About Antibiotic Prescribing in Primary Care: Protocol for Two Linked Trials With Embedded Process Evaluations (OH Trial)
Antibiotic overuse is common and antibiotic prescribing contributes to rising rates of antimicrobial resistance. Primary care physicians prescribe the majority of all antibiotics and there is large inter-physician variability in prescribing that cannot be explained by differences in patient populations.
In Ontario, audit and feedback (A\&F) is routinely offered to primary care providers from a variety of sources. Ontario Health - an agency created by the Government of Ontario - provides A\&F via email to physicians who voluntarily sign up for their "MyPractice" reports. These are multi-topic reports with aggregated (physician-level) data. As of November 2021, the MyPractice reports for family physicians will include data on antibiotic prescribing. To date, less than half of Ontario family physicians have signed up for the MyPractice reports from Ontario Health.
For this study, the investigators will conduct a trial to investigate the effect of adding viral prescription pad resources to family physician A\&F received through a MyPractice: Primary Care report. This evaluation provides an opportunity to determine if the addition of this resource to an A\&F intervention increases changes to antibiotic prescribing.
Read the detailed description
This study will examine ways to optimize the effects of A\&F for antibiotic prescribing in primary care. This study will aim to determine if emphasis (or not) on the use of a viral prescription pad developed by Choosing Wisely Canada (CWC) can help physicians act upon the feedback from their MyPractice report to reduce their antibiotic prescribing.
Antibiotic prescribing feedback within the multi-topic MyPractice: Primary Care report will be sent to family physicians who signed up for this program from Ontario Health. This report includes a link to the Choosing Wisely viral prescription pad. Physicians will be randomized to the control group or intervention group. Physicians in the intervention group will receive additional emphasis on the use of the viral prescription pad and will also have a paper copy of the prescription pad mailed to their practice.
One month after the initial intervention, participants will be invited to complete a process evaluation survey to determine why or why not the intervention worked and how individual factors can affect physician motivation, willingness, and ability to engage in new practices. Intervention participants will also be invited to take part in a process evaluation interview.
- Conditions
- Infection
- Being tested
- Emphasis on the Choosing Wisely Viral Prescription Pad
- Keywords
- audit and feedback, antibiotics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emphasis on the Choosing Wisely Viral Prescription PadBehavioural
We will investigate the effects of emphasizing the use of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Viral prescription pad + emphasis | Experimental | Physicians in this group will receive their usual MyPractice: Primary Care report from Ontario Health. This report will include antibiotic prescribing indicators as well as a link to the viral prescription pad. As part of the intervention, these physicians will also receive additional emphasis on the viral prescription pad by 1) encouraging it in the dissemination email of the MyPractice feedback report, and (2) mailing a paper version of the viral prescription pad with instructions on embedding the viral prescription pad into the recipient's EMR. Receives: Behavioral: Emphasis on the Choosing Wisely Viral Prescription Pad |
| Control group | No intervention | Physicians in this group will receive their usual MyPractice: Primary Care report from Ontario Health. This report will include antibiotic prescribing indicators as well as a link to the viral prescription pad. This group will not receive any additional emphasis on the viral prescription pad and will not receive a paper copy in the mail. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescribing rate
Total number of antibiotic prescriptions per 1000 65+ patient visits
Measured: 6 months
Secondary outcomes (10)
Proportion Antibiotic Rx with Prolonged Duration
Antibiotics prescribed for more than 7 days per episode
Measured: 6 months
Proportion Antibiotic Rx with Prolonged Duration
Antibiotics prescribed for more than 7 days per episode
Measured: 12 months
Antibiotic drug costs
Cost in CDN$
Measured: 6 months
Antibiotic drug costs
Cost in CDN$
Measured: 12 months
Antibiotics prescribed for viral infections
Total number of antibiotic rx per 1000 65+ patient visits for presumed viral condition (and thus likely unnecessary) based on administrative database diagnostic codes
Measured: 6 months
Antibiotics prescribed for viral infections
Total number of antibiotic rx per 1000 65+ patient visits for presumed viral condition (and thus likely unnecessary) based on administrative database diagnostic codes
Measured: 12 months
Total Antibiotic Days of Therapy
Total number DOTs per 1000 65+ patient visits
Measured: 6 months
Total Antibiotic Days of Therapy
Total number DOTs per 1000 65+ patient visits
Measured: 12 months
Proportion of broad spectrum antibiotic prescriptions
antibiotic prescriptions that are broad spectrum
Measured: 6 months
Proportion of broad spectrum antibiotic prescriptions
antibiotic prescriptions that are broad spectrum
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 posted14 Sep 2021
- Study start15 Dec 2021
- Primary completion15 Jun 2022
- Study completion15 Dec 2022
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 InfectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Control Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Agency for Health Protection and Promotion, College of Family Physicians of Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Noah Ivers, Women's College Hospital
- Investigators
- Noah M Ivers, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044052
- Sponsor's protocol ID
- 2020-0024-E (OH Trial)
- Status last verified
- Jan 2023
- First submitted
- 3 Sep 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share this data
Publications
Shuldiner J, Lacroix M, Saragosa M, Reis C, Schwartz KL, Gushue S, Leung V, Grimshaw J, Silverman M, Thavorn K, Leis JA, Kidd M, Daneman N, Tradous M, Langford B, Morris AM, Lam J, Garber G, Brehaut J, Taljaard M, Greiver M, Ivers NM. Process evaluation of two large randomized controlled trials to understand factors influencing family physicians' use of antibiotic audit and feedback reports. Implement Sci. 2024 Sep 16;19(1):65. doi: 10.1186/s13012-024-01393-5.
PubMed 39285305Shuldiner J, Schwartz KL, Langford BJ, Ivers NM; Ontario Healthcare Implementation Laboratory study team. Optimizing responsiveness to feedback about antibiotic prescribing in primary care: protocol for two interrelated randomized implementation trials with embedded process evaluations. Implement Sci. 2022 Feb 14;17(1):17. doi: 10.1186/s13012-022-01194-8.
PubMed 35164805
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Peer-comparisons, Emphasis on Harms, and/or Inclusion of Viral Prescription Pad Resources Increase Responsiveness to Feedback About Antibiotic Prescribing in Primary Care: Protocol for Two Linked Trials With Embedded Process Evaluations (OH Trial)
- ClinicalTrials.gov ID
- NCT05044052
- Acronym / sponsor ID
- 2020-0024-E (OH Trial)
- Conditions
- Infection
- Keywords
- audit and feedback, antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,379 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Ontario Agency for Health Protection and Promotion, College of Family Physicians of Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 14 Sep 2021 (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.
Antibiotic overuse is common and antibiotic prescribing contributes to rising rates of antimicrobial resistance. Primary care physicians prescribe the majority of all antibiotics and there is large inter-physician variability in prescribing that cannot be explained by differences in patient populations.
In Ontario, audit and feedback (A\&F) is routinely offered to primary care providers from a variety of sources. Ontario Health - an agency created by the Government of Ontario - provides A\&F via email to physicians who voluntarily sign up for their "MyPractice" reports. These are multi-topic reports with aggregated (physician-level) data. As of November 2021, the MyPractice reports for family physicians will include data on antibiotic prescribing. To date, less than half of Ontario family physicians have signed up for the MyPractice reports from Ontario Health.
For this study, the investigators will conduct a trial to investigate the effect of adding viral prescription pad resources to family physician A\&F received through a MyPractice: Primary Care report. This evaluation provides an opportunity to determine if the addition of this resource to an A\&F intervention increases changes to antibiotic prescribing.
Detailed description
This study will examine ways to optimize the effects of A\&F for antibiotic prescribing in primary care. This study will aim to determine if emphasis (or not) on the use of a viral prescription pad developed by Choosing Wisely Canada (CWC) can help physicians act upon the feedback from their MyPractice report to reduce their antibiotic prescribing.
Antibiotic prescribing feedback within the multi-topic MyPractice: Primary Care report will be sent to family physicians who signed up for this program from Ontario Health. This report includes a link to the Choosing Wisely viral prescription pad. Physicians will be randomized to the control group or intervention group. Physicians in the intervention group will receive additional emphasis on the use of the viral prescription pad and will also have a paper copy of the prescription pad mailed to their practice.
One month after the initial intervention, participants will be invited to complete a process evaluation survey to determine why or why not the intervention worked and how individual factors can affect physician motivation, willingness, and ability to engage in new practices. Intervention participants will also be invited to take part in a process evaluation interview.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Viral prescription pad + emphasis | Experimental | Behavioral: Emphasis on the Choosing Wisely Viral Prescription PadPhysicians in this group will receive their usual MyPractice: Primary Care report from Ontario Health. This report will include antibiotic prescribing indicators as well as a link to the viral prescription pad. As part of the intervention, these physicians will also receive additional emphasis on the viral prescription pad by 1) encouraging it in the dissemination email of the MyPractice feedback report, and (2) mailing a paper version of the viral prescription pad with instructions on embedding the viral prescription pad into the recipient's EMR. |
| Control group | No intervention | –Physicians in this group will receive their usual MyPractice: Primary Care report from Ontario Health. This report will include antibiotic prescribing indicators as well as a link to the viral prescription pad. This group will not receive any additional emphasis on the viral prescription pad and will not receive a paper copy in the mail. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Family physicians who sign up for the MyPractice reports by September 2021
Key exclusion criteria (1 listed)
- Family physicians who did not sign up for the MyPractice reports by September 2021
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 |
|---|---|---|
| Emphasis on the Choosing Wisely Viral Prescription PadWe will investigate the effects of emphasizing the use of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing. | Behavioural | Intervention Group - Viral prescription pad + emphasis |
Primary outcome
Antibiotic prescribing rate
Time frame: 6 months
Total number of antibiotic prescriptions per 1000 65+ patient visits
10 secondary outcomes
Proportion Antibiotic Rx with Prolonged Duration
Time frame: 6 months
Proportion Antibiotic Rx with Prolonged Duration
Time frame: 12 months
Antibiotic drug costs
Time frame: 6 months
Antibiotic drug costs
Time frame: 12 months
Antibiotics prescribed for viral infections
Time frame: 6 months
Antibiotics prescribed for viral infections
Time frame: 12 months
Total Antibiotic Days of Therapy
Time frame: 6 months
Total Antibiotic Days of Therapy
Time frame: 12 months
Proportion of broad spectrum antibiotic prescriptions
Time frame: 6 months
Proportion of broad spectrum antibiotic prescriptions
Time frame: 12 months
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 5 Jan 2023.
- Derived from this study: PubMed 39285305Shuldiner J, Lacroix M, Saragosa M, Reis C, Schwartz KL, Gushue S, Leung V, Grimshaw J, Silverman M, Thavorn K, Leis JA, Kidd M, Daneman N, Tradous M, Langford B, Morris AM, Lam J, Garber G, Brehaut J, Taljaard M, Greiver M, Ivers NM. Process evaluation of two large randomized controlled trials to understand factors influencing family physicians' use of antibiotic audit and feedback reports. Implement Sci. 2024 Sep 16;19(1):65. doi: 10.1186/s13012-024-01393-5.
- Derived from this study: PubMed 35164805Shuldiner J, Schwartz KL, Langford BJ, Ivers NM; Ontario Healthcare Implementation Laboratory study team. Optimizing responsiveness to feedback about antibiotic prescribing in primary care: protocol for two interrelated randomized implementation trials with embedded process evaluations. Implement Sci. 2022 Feb 14;17(1):17. doi: 10.1186/s13012-022-01194-8.
- Individual participant dataSharing planned: No. No plan to share this data
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Noah M Ivers, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emphasis on the Choosing Wisely Viral Prescription Pad in people with Infection, run by Women's College Hospital at 1 site 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 1 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: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Antibiotic prescribing rate (time frame: 6 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 NCT05044052, 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 5 Jan 2023.