GEMINI Research Program
Toronto, Ontario, M5B 1T8, Canada
NCT Number: NCT07189364
The purpose of this study is to evaluate the effect of a peer comparison feedback report, combined with a best practices toolkit, on the volume of antimicrobial use by general medicine physicians. The study also aims to understand the qualitative and quantitative impact of peer comparison feedback on antimicrobial prescribing in hospital.
This study will leverage data from GEMINI, a hospital research collaborative that collects administrative and clinical data from 30+ Ontario hospitals, to create these peer comparison feedback reports.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5B 1T8, Canada
Antimicrobial resistance (AMR) is a critical threat to human health, having led to the deaths of 14,000 people in Canada in 2018 and 1.25 million people globally in 2019. There has been limited success in overcoming AMR through developing new antimicrobials, primarily due to inadequate investment in new antimicrobial discovery, and economic and regulatory hurdles. Acquired resistance is also likely to occur as newer agents come to market. The World Health Organization and the Public Health Agency of Canada have identified overuse of antimicrobials as a primary ongoing driver of AMR. Therefore, optimizing antimicrobial use must be a cornerstone of our response to the AMR crisis.
Antimicrobial stewardship (AMS) interventions (activities designed to safely improve antimicrobial use) can lead to reductions in antimicrobial use, antimicrobial costs, hospital length of stay, and C. difficile rates. Previous work has demonstrated that audit and feedback with peer comparison in a primary care setting can lead to a clinically significant reduction in antimicrobial use, with no demonstrable safety concerns. For example, the study team previously tested a peer comparison letter to primary care providers in the highest quartile of antimicrobial prescribing across Ontario and found a clinically significant 4% relative reduction in total antimicrobial prescribing. This extrapolates to nearly 150,000 fewer prescriptions and drug-cost savings of $2.7 million annually for the province.
General medicine wards are an important target for antimicrobial stewardship efforts, as they care for the largest group of hospital inpatients, patients are often medically complex, and admissions are heterogeneous in condition/disease. However, physician-level prescribing data for hospitalized patients has historically been difficult to collect and attribute to a specific clinician, limiting rigorous evaluation. This trial will leverage GEMINI's pharmacy data to create physician-level peer-comparison reports for physicians practicing on general medical wards. Building on a previous CIHR-funded RCT led by Drs. Desveaux and Ivers, this trial will also develop a mixed methods process evaluation methodology to assess fidelity and mechanism of action.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention will be an electronic, individualized, peer-comparison feedback report on the participant's antimicrobial prescribing practices, combined with a knowledge toolkit focused on optimizing antimicrobial use.
Time frame: The primary outcome will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
The primary trial outcome will be aggregate DOT (Days of Therapy)/100 days present, at the physician level. DOT are defined by the sum of days treated with each antimicrobial agent (e.g., 2 agents each day over 2 days is 4 DOT/days present). Days present are defined by the number of days between hospital admission and discharge attributed to each physician. Partial days are considered days present based upon the percentage of the day in hospital calculated by hour of admission and discharge. This highly relevant outcome captures many axes of use including initiation and discontinuation decisions.
Time frame: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
Initiation of antimicrobial therapy (as measured by the number of antimicrobial agents per admission within the first 24 hours of hospital admission for each physician)
Time frame: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
Discontinuation of antimicrobial therapy within 72 hours (as measured by patients on antimicrobials initially with subsequent stopping event and no antimicrobial exposure for greater than or equal to 48 hours).
Time frame: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
Antimicrobial-free days (expressed as a percentage of all days present per physician without exposure to antimicrobial agents)
Time frame: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
Antimicrobial choice (as assessed by antimicrobial drug and drug class as a percentage of overall antimicrobial use).
Time frame: This process evaluation outcome will be measured within 12 months of the intervention delivery (i.e., during the follow-up period).
As part of the embedded process evaluation methodology, the mechanism of action will be assessed via an optional follow-up interview.
Time frame: This process evaluation outcome will be measured within 12 months of the intervention delivery (i.e., during the follow-up period).
As part of the embedded process evaluation methodology, fidelity of receipt will be assessed via the inclusion of an optional online survey in the report delivery email.
Time frame: This process evaluation outcome will be measured within 12 months of the intervention delivery (i.e., during the follow-up period).
As part of the embedded process evaluation methodology, fidelity of implementation will be assessed via the inclusion of an optional online survey in the report delivery email.
Time frame: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
Though this study is low-risk, this patient level clinical outcome will help assess any impact to patient safety.
Time frame: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
Though this study is low-risk, this patient level clinical outcome will help assess any impact to patient safety.
Time frame: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
Though this study is low-risk, this patient level clinical outcome will help assess any impact to patient safety.
Time frame: All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).
Though this study is low-risk, this patient level clinical outcome will help assess any impact to patient safety.
Fahad Razak
Other
Acronym: PEER AIMS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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