Hospital Wide Roll-Out of Antimicrobial Stewardship

Study Overview
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Brief Summary
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Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has published guidelines stating that all hospitals should develop an institutional program to enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic stewardship audit-and-feedback intervention for all patients reaching their third or tenth day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The investigators hypothesize that this intervention will result in similar benefits outside of the intensive care unit, and so expanded the intervention to non-ICU medical and surgical wards. To increase the rigor of our program evaluation, the roll-out was conducted in a stepped-wedge randomized controlled design.

Official Title
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Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial

Conditions
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Bacterial Infections

Intervention / Treatment
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* Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics


Participation Criteria
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Eligibility Criteria
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All patients admitted to the medical/surgical services will be included in statistical analysis of program evaluation. The inclusion/exclusion criteria below, just define who receives the antibiotic stewardship intervention on each service. Inclusion Criteria: admitted to one of these services: general internal medicine, cardiology, nephrology, orthopedic surgery, neurosurgery, general surgery or trauma surgery receiving 3rd or 10th day of treatment with one of the following antibiotics: ceftriaxone, ceftazidime, piperacillin-tazobactam, ciprofloxacin, levofloxacin, meropenem, ertapenem, vancomycin Exclusion Criteria: patient being followed by the infectious diseases consult service
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic stewardship intervention<br>Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial | Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics<br>* See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.<br>|
| No Intervention: Control<br>The pre-intervention period will serve as the control period on each medical and surgical service. The cross-over is uni-directional from control to intervention; all services receive the intervention by the end of the study. This is a stepped wedge design. The order of roll-out is randomized. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs) | Targeted broadspectrum antibiotics include third generation cephalosporins (ceftriaxone, ceftazidime), beta-lactam beta-lactamase inhibitors (piperacillin-tazobactam), fluoroquinolones (ciprofloxacin, levofloxacin), carbapenems (ertapenem and meropenem), and glycopeptides (vancomycin) DOTs are defined as the number of unique antibiotic agents prescribed each day (regardless of dose) | patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs) | -Definition as per primary outcome, but can include any antibiotic (not just those broadspectrum agents targeted by the intervention) | patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) | 
| Costs of antibiotic therapy ($) per patient day | Based on acquisition costs for each agent. | patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) | 
| Hospital-acquired Clostridium difficile infection. | Cases of Clostridium difficile infection deemed to have been acquired during the current hospital stay by prospective Infection Prevention & Control surveillance team. | patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) | 
| Antibiotic susceptibility of gram negative bacterial isolates |  | patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic stewardship., Clostridium difficile infection., Antibiotic resistance.