Do Fair Comparisons or Harms Data Increase Responsiveness to Feedback About Antibiotic Prescribing: 2x2 Factorial Trial

NCT04594200 | Completed

• 1 other identifier: 2020-0024-E (PHO Trial)
• Study Type: interventional
• Target: 5,107
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infection

Keywords

Antibiotics; Audit and Feedback

Outcome Measures

Primary Outcomes (1)

• Antibiotic prescribing rate

  total number of antibiotic prescriptions per 1000 65+ patient visits

  6 months

Secondary Outcomes (10)

• Proportion Antibiotic Rx with Prolonged Duration

  6 months

• Proportion Antibiotic Rx with Prolonged Duration

  12 months

• Antibiotic drug costs

  6 months

• Antibiotic drug costs

  12 months

• Antibiotics prescribed for viral infections

  6 months

Study Arms (5)

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.

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.

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.

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.

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.

Interventions

Audit and Feedback (A&F) BEHAVIORAL

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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)

Sponsors & Collaborators

• Women's College Hospital: lead
• Ontario Agency for Health Protection and Promotion: collaborator
• College of Family Physicians of Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5G 1N8, Canada

Location

Related Publications (4)

• Saqib 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.

  PMID: 40591360 DERIVED

• 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.

  PMID: 39285305 DERIVED

• Schwartz 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.

  PMID: 38839101 DERIVED

• Shuldiner 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.

  PMID: 35164805 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Noah M Ivers

  WCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Physician, Canada Research Chair (Tier 2) in Implementation of Evidence Based Practice

Model Details: 2x2 Pragmatic Factorial Randomized Control Trial

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 20, 2020
• Study Start: January 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: January 1, 2023
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)