InfectionNCT04594200
Do Fair Comparisons or Harms Data Increase Responsiveness to Feedback About Antibiotic Prescribing: 2x2 Factorial Trial
A study testing Audit and Feedback (A&F) 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?
- Audit and Feedback (A&F)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,107 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2022to 1 Jan 2023
- 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 with an active practice who prescribe antibiotics in Ontario to patients aged 65 or older.
- Family physicians who did not sign up by September 2021 to receive the MyPractice report
Who cannot join
- <100 unique patient visits in the most recent year or two of the three prior years for patients 65 years of age or older;
- <10 antibiotic prescriptions to patients 65+ in the most recent year or two of the three prior years; or
- previously opted out of antibiotic prescribing letters from PHO (n= 15)
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 (PHO 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.
Peer comparison audit and feedback (A\&F) can act as an effective behavioural intervention to reduce unnecessary antibiotic use. The range of effects seen in prior A\&F trials could be attributed, at least in part, to differences in the way the feedback interventions were designed. In fall 2018, the investigators conducted an audit and feedback trial of mailed letters to 3500 family physicians in Ontario who prescribe the highest volume of antibiotics [NCT03776383]. While effective, family physicians questioned the credibility of the report in terms of its ability to fairly account for their practice size and population.
Read more
In Ontario, 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 A\&F in family physicians not already receiving A\&F through a MyPractice: Primary Care report. Physicians who do not already receive antibiotic prescribing feedback through a MyPractice report will receive personalized antibiotic prescribing feedback through a letter mailed out from PHO. This large-scale evaluation provides an opportunity to evaluate not only whether A\&F using such data is helpful in the post-covid context, but how best to design the A\&F intervention and to explore why we observed (or not) changes in 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 answer the following questions:
- Do patients of family physicians receiving A\&F about antibiotic prescribing receive fewer antibiotics compared to patients of family physicians that do not receive A\&F?
- Does the effects of A\&F vary with the following design features? i) case-mix adjusted (or simple) peer comparators to represent a target for the prescribing quality indicators ii) emphasis (or not) on antibiotic-associated harms in addition to messages that focus on lack of benefit
This trial will include family physicians who did not opt-in to receive MyPractice: Primary Care report from Ontario Health. Physicians will be randomized to the control group or intervention group. Physicians in the intervention group will receive a personalized antibiotic prescribing feedback letter that will include personalized data regarding total antibiotic prescribing per 1000 patient visits and proportion of antibiotic prescriptions provided for a duration of >7 days. The letter will also contain two experimental factors: 1: Simple vs complex peer comparators; and 2) Emphasis or not on antibiotic harms. For the complex (adjusted) comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. For the harms vs no harms factor, physicians will be either provided with information that focuses on lack of benefit for certain conditions (no harms), or with information that emphasizes the potential harms caused by unnecessary use of antibiotics. The feedback letters will be mailed to each physicians' primary practice address, along with a viral prescription pad developed by Choosing Wisely Canada.
One month after the initial intervention, 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
- Audit and Feedback (A&F)
- Keywords
- Antibiotics, Audit and Feedback
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and Feedback (A&F)Behavioural
In this protocol, we propose comparing 2 intervention design elements in a multifactorial design. Specifically, we will evaluate:
- an emphasis on antibiotic-associated harms in comparison to messages that focus on lack of benefit; ii) simple versus adjusted peer comparators to represent a target for the prescribing quality indicators
We will also investigate the effects of the inclusion 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: Harms Emphasis - Simple Comparator | Experimental | Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a simple comparator to represent a target or benchmark for antibiotic prescribing. For the simple comparator, we will rank the antibiotic prescribing outcomes for all Ontario family physicians and use the lowest quartile as the benchmark. The letter will also include information on both lack of benefit and potential harms caused by unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month post initial dissemination. Receives: Behavioral: Audit and Feedback (A&F) |
| Intervention Group: Harms Emphasis - Complex Comparator | Experimental | Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a complex (adjusted) comparator to represent a target or benchmark for antibiotic prescribing. For the complex comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. We will adjust the prescribing indicators for patient sex, number of patients >85 years, rurality, continuity of care score, proportion of emergency room practice, proportion nursing home practice, neighborhood income quintile of patients, and rates of common patient comorbidities. The letter will also include information on both lack of benefit and potential harms caused by unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month later. Receives: Behavioral: Audit and Feedback (A&F) |
| Intervention Group: No Harms Emphasis - Simple Comparator | Experimental | Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a simple comparator to represent a target or benchmark for antibiotic prescribing. For the simple comparator we will rank the antibiotic prescribing outcomes for all Ontario family physicians and use the lowest quartile as the benchmark. The letter will also include information on lack of benefit of unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month post initial dissemination. Receives: Behavioral: Audit and Feedback (A&F) |
| Intervention Group: No Harms Emphasis - Complex Comparator | Experimental | Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a complex (adjusted) comparator to represent a target or benchmark for antibiotic prescribing. For the complex comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. We will adjust the prescribing indicators for patient sex, number of patients >85 years, rurality, continuity of care score, proportion of emergency room practice, proportion nursing home practice, neighborhood income quintile of patients, and rates of common patient comorbidities. The letter will also include information on lack of benefit of unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month later. Receives: Behavioral: Audit and Feedback (A&F) |
| Control Group | No intervention | Participants in this group will not receive a personalized antibiotic prescribing feedback letter and they will not receive a viral prescription pad. |
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 posted20 Oct 2020
- Study start15 Jan 2022
- Primary completion15 Jul 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Factorial
- Model description
- 2x2 Pragmatic Factorial Randomized Control Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 5,107 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, Principal investigator, WCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594200
- Sponsor's protocol ID
- 2020-0024-E (PHO Trial)
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2020
- 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
Schwartz KL, Bai L, Brown KA, Tadrous M, Grimshaw JM, Witteman HO, Friedman L, Langford BJ, Leung V, Gomes T, Garber G, Taljaard M, Shuldiner J, Gushue S, Silverman M, Daneman N, Brehaut J, Presseau J, Leis JA, Lacroix M, Zwarenstein M, Masucci L, Thavorn K, Ivers N. Safety of antibiotic audit and feedback: secondary analysis of a randomized controlled trial. J Antimicrob Chemother. 2026 Jun 3;81(7):dkag216. doi: 10.1093/jac/dkag216.
PubMed 42313420Saqib K, Ivers N, Brown KA, Daneman N, Leung V, Langford BJ, Garber G, Grimshaw JM, Silverman MS, Taljaard M, Brehaut J, Thavorn K, Lacroix M, Friedman L, Shuldiner J, Gomes T, Gushue S, Leis JA, Zwarenstein M, Schwartz KL. Spillover From an Intervention on Antibiotic Prescribing for Family Physicians: A Post Hoc Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518261. doi: 10.1001/jamanetworkopen.2025.18261.
PubMed 40591360Shuldiner 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 39285305Schwartz KL, Shuldiner J, Langford BJ, Brown KA, Schultz SE, Leung V, Daneman N, Tadrous M, Witteman HO, Garber G, Grimshaw JM, Leis JA, Presseau J, Silverman MS, Taljaard M, Gomes T, Lacroix M, Brehaut J, Thavorn K, Gushue S, Friedman L, Zwarenstein M, Ivers N. Mailed feedback to primary care physicians on antibiotic prescribing for patients aged 65 years and older: pragmatic, factorial randomised controlled trial. BMJ. 2024 Jun 5;385:e079329. doi: 10.1136/bmj-2024-079329.
PubMed 38839101Shuldiner 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 (PHO Trial)
- ClinicalTrials.gov ID
- NCT04594200
- Acronym / sponsor ID
- 2020-0024-E (PHO Trial)
- Conditions
- Infection
- Keywords
- Antibiotics, Audit and Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,107 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 Jan 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 20 Oct 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.
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.
Peer comparison audit and feedback (A\&F) can act as an effective behavioural intervention to reduce unnecessary antibiotic use. The range of effects seen in prior A\&F trials could be attributed, at least in part, to differences in the way the feedback interventions were designed. In fall 2018, the investigators conducted an audit and feedback trial of mailed letters to 3500 family physicians in Ontario who prescribe the highest volume of antibiotics [NCT03776383]. While effective, family physicians questioned the credibility of the report in terms of its ability to fairly account for their practice size and population.
In Ontario, 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 A\&F in family physicians not already receiving A\&F through a MyPractice: Primary Care report. Physicians who do not already receive antibiotic prescribing feedback through a MyPractice report will receive personalized antibiotic prescribing feedback through a letter mailed out from PHO. This large-scale evaluation provides an opportunity to evaluate not only whether A\&F using such data is helpful in the post-covid context, but how best to design the A\&F intervention and to explore why we observed (or not) changes in 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 answer the following questions:
- Do patients of family physicians receiving A\&F about antibiotic prescribing receive fewer antibiotics compared to patients of family physicians that do not receive A\&F?
- Does the effects of A\&F vary with the following design features? i) case-mix adjusted (or simple) peer comparators to represent a target for the prescribing quality indicators ii) emphasis (or not) on antibiotic-associated harms in addition to messages that focus on lack of benefit
This trial will include family physicians who did not opt-in to receive MyPractice: Primary Care report from Ontario Health. Physicians will be randomized to the control group or intervention group. Physicians in the intervention group will receive a personalized antibiotic prescribing feedback letter that will include personalized data regarding total antibiotic prescribing per 1000 patient visits and proportion of antibiotic prescriptions provided for a duration of >7 days. The letter will also contain two experimental factors: 1: Simple vs complex peer comparators; and 2) Emphasis or not on antibiotic harms. For the complex (adjusted) comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. For the harms vs no harms factor, physicians will be either provided with information that focuses on lack of benefit for certain conditions (no harms), or with information that emphasizes the potential harms caused by unnecessary use of antibiotics. The feedback letters will be mailed to each physicians' primary practice address, along with a viral prescription pad developed by Choosing Wisely Canada.
One month after the initial intervention, 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
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 2x2 Pragmatic Factorial Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Harms Emphasis - Simple Comparator | Experimental | Behavioral: Audit and Feedback (A&F)Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a simple comparator to represent a target or benchmark for antibiotic prescribing. For the simple comparator, we will rank the antibiotic prescribing outcomes for all Ontario family physicians and use the lowest quartile as the benchmark. The letter will also include information on both lack of benefit and potential harms caused by unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month post initial dissemination. |
| Intervention Group: Harms Emphasis - Complex Comparator | Experimental | Behavioral: Audit and Feedback (A&F)Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a complex (adjusted) comparator to represent a target or benchmark for antibiotic prescribing. For the complex comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. We will adjust the prescribing indicators for patient sex, number of patients >85 years, rurality, continuity of care score, proportion of emergency room practice, proportion nursing home practice, neighborhood income quintile of patients, and rates of common patient comorbidities. The letter will also include information on both lack of benefit and potential harms caused by unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month later. |
| Intervention Group: No Harms Emphasis - Simple Comparator | Experimental | Behavioral: Audit and Feedback (A&F)Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a simple comparator to represent a target or benchmark for antibiotic prescribing. For the simple comparator we will rank the antibiotic prescribing outcomes for all Ontario family physicians and use the lowest quartile as the benchmark. The letter will also include information on lack of benefit of unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month post initial dissemination. |
| Intervention Group: No Harms Emphasis - Complex Comparator | Experimental | Behavioral: Audit and Feedback (A&F)Physicians in this group will receive a personalized antibiotic prescribing feedback letter which contains a complex (adjusted) comparator to represent a target or benchmark for antibiotic prescribing. For the complex comparator, recipients will be compared only to top-performing 'like-peers' - the group of physicians with similar complexity and numbers of patients. We will adjust the prescribing indicators for patient sex, number of patients >85 years, rurality, continuity of care score, proportion of emergency room practice, proportion nursing home practice, neighborhood income quintile of patients, and rates of common patient comorbidities. The letter will also include information on lack of benefit of unnecessary use of antibiotics. Physicians will also receive a paper-copy viral prescription pad and will receive the intervention letter again 1-month later. |
| Control Group | No intervention | –Participants in this group will not receive a personalized antibiotic prescribing feedback letter and they will not receive a viral prescription pad. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Family physicians with an active practice who prescribe antibiotics in Ontario to patients aged 65 or older.
- Family physicians who did not sign up by September 2021 to receive the MyPractice report
Key exclusion criteria (3 listed)
- <100 unique patient visits in the most recent year or two of the three prior years for patients 65 years of age or older;
- <10 antibiotic prescriptions to patients 65+ in the most recent year or two of the three prior years; or
- previously opted out of antibiotic prescribing letters from PHO (n= 15)
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 (A&F)In this protocol, we propose comparing 2 intervention design elements in a multifactorial design. Specifically, we will evaluate: i) an emphasis on antibiotic-associated harms in comparison to messages that focus on lack of benefit; ii) simple versus adjusted peer comparators to represent a target for the prescribing quality indicators We will also investigate the effects of the inclusion 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: Harms Emphasis - Complex Comparator, Intervention Group: Harms Emphasis - Simple Comparator, Intervention Group: No Harms Emphasis - Complex Comparator, Intervention Group: No Harms Emphasis - Simple Comparator |
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 42313420Schwartz KL, Bai L, Brown KA, Tadrous M, Grimshaw JM, Witteman HO, Friedman L, Langford BJ, Leung V, Gomes T, Garber G, Taljaard M, Shuldiner J, Gushue S, Silverman M, Daneman N, Brehaut J, Presseau J, Leis JA, Lacroix M, Zwarenstein M, Masucci L, Thavorn K, Ivers N. Safety of antibiotic audit and feedback: secondary analysis of a randomized controlled trial. J Antimicrob Chemother. 2026 Jun 3;81(7):dkag216. doi: 10.1093/jac/dkag216.
- Derived from this study: PubMed 40591360Saqib K, Ivers N, Brown KA, Daneman N, Leung V, Langford BJ, Garber G, Grimshaw JM, Silverman MS, Taljaard M, Brehaut J, Thavorn K, Lacroix M, Friedman L, Shuldiner J, Gomes T, Gushue S, Leis JA, Zwarenstein M, Schwartz KL. Spillover From an Intervention on Antibiotic Prescribing for Family Physicians: A Post Hoc Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518261. doi: 10.1001/jamanetworkopen.2025.18261.
- 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 38839101Schwartz KL, Shuldiner J, Langford BJ, Brown KA, Schultz SE, Leung V, Daneman N, Tadrous M, Witteman HO, Garber G, Grimshaw JM, Leis JA, Presseau J, Silverman MS, Taljaard M, Gomes T, Lacroix M, Brehaut J, Thavorn K, Gushue S, Friedman L, Zwarenstein M, Ivers N. Mailed feedback to primary care physicians on antibiotic prescribing for patients aged 65 years and older: pragmatic, factorial randomised controlled trial. BMJ. 2024 Jun 5;385:e079329. doi: 10.1136/bmj-2024-079329.
- 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.
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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.
Noah M Ivers principal investigator
WCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Feedback (A&F) 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 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 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 NCT04594200, which also lists 5 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.