NCT04594200

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

Completed NA Last updated 5 January 2023

What this trial tests

NA trial testing Audit and Feedback (A&F) in Infection in 5,107 participants. Completed in 1 January 2023.

Timeline

15 January 2022

Primary endpoint
15 July 2022

1 January 2023

Quick facts

Lead sponsor	Women's College Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	health services research
Enrollment	5,107
Start date	15 January 2022
Primary completion	15 July 2022
Estimated completion	1 January 2023
Sites	1 location across Canada

Drugs / interventions tested

• Audit and Feedback (A&F)

Conditions studied

• Infection — all drugs for Infection →

Sponsor

Women's College Hospital

Who can join

Eligibility, any sex, with Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mailed feedback to primary care physicians on antibiotic prescribing for patients aged 65 years and older: pragmatic, factorial randomised controlled trial.
   Schwartz KL, Shuldiner J, Langford BJ, Brown KA, et al · · 2024 · cited 9× · PMID 38839101 · DOI 10.1136/bmj-2024-079329
2. Optimizing responsiveness to feedback about antibiotic prescribing in primary care: protocol for two interrelated randomized implementation trials with embedded process evaluations.
   Shuldiner J, Schwartz KL, Langford BJ, Ivers NM, et al · · 2022 · cited 6× · PMID 35164805 · DOI 10.1186/s13012-022-01194-8
3. Process evaluation of two large randomized controlled trials to understand factors influencing family physicians' use of antibiotic audit and feedback reports.
   Shuldiner J, Lacroix M, Saragosa M, Reis C, et al · · 2024 · cited 2× · PMID 39285305 · DOI 10.1186/s13012-024-01393-5
4. Spillover From an Intervention on Antibiotic Prescribing for Family Physicians: A Post Hoc Secondary Analysis of a Randomized Clinical Trial.
   Saqib K, Ivers N, Brown KA, Daneman N, et al · · 2025 · cited 1× · PMID 40591360 · DOI 10.1001/jamanetworkopen.2025.18261
5. 2024 Annual Conference Conférence Annuelle.
   · 2024 · PMID 40678421 · DOI 10.3138/jammi.9.s1.abst
6. Evaluating Audit and Feedback Strategies to Reduce Antibiotic Prescribing in Primary Care: A Randomized Controlled Trial
   · 2023