Hospital Wide Roll-Out of Antimicrobial Stewardship

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Bacterial Infections	Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	19220 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial
Study Start Date :	April 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	April 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Antibiotic stewardship intervention; 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; See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.
No Intervention: Control; 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.

Outcome Measures

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Primary Outcome Measures :

1. Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs) [ Time Frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) ]
   • 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)

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Ontario Ministry of Health and Long Term Care

Investigators

Principal Investigator:	Nick Daneman	Sunnybrook Health Sciences Centre

More Information

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Publications:

Elligsen M, Walker SA, Simor A, Daneman N. Prospective audit and feedback of antimicrobial stewardship in critical care: program implementation, experience, and challenges. Can J Hosp Pharm. 2012 Jan;65(1):31-6.

Elligsen M, Walker SA, Pinto R, Simor A, Mubareka S, Rachlis A, Allen V, Daneman N. Audit and feedback to reduce broad-spectrum antibiotic use among intensive care unit patients: a controlled interrupted time series analysis. Infect Control Hosp Epidemiol. 2012 Apr;33(4):354-61. doi: 10.1086/664757.

Responsible Party:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT01587937 History of Changes
Other Study ID Numbers:	416-2009
First Posted:	April 30, 2012
Last Update Posted:	November 19, 2014
Last Verified:	November 2014

Keywords provided by Sunnybrook Health Sciences Centre:

Antibiotic stewardship.; Clostridium difficile infection.; Antibiotic resistance.

Additional relevant MeSH terms:

Bacterial Infections; Anti-Bacterial Agents; Antibiotics, Antitubercular; Anti-Infective Agents; Antitubercular Agents