Clinical trial NCT01587937: Hospital Wide Roll-Out of Antimicrobial Stewardship
Official title: Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infections
Keywords: Antibiotic stewardship.
Clostridium difficile infection.
Antibiotic resistance.
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2012-04-30
Enrollment: 19220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
timeFrame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Secondary outcomes:
measure: Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)
timeFrame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
measure: Costs of antibiotic therapy ($) per patient day
timeFrame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
measure: Hospital-acquired Clostridium difficile infection.
timeFrame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
measure: Antibiotic susceptibility of gram negative bacterial isolates
timeFrame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Nick Daneman
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.4212/cjhp.v65i1.1101. No abstract available.
citation: 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.