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Hospital Wide Roll-Out of Antimicrobial Stewardship

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ClinicalTrials.gov Identifier: NCT01587937
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

April 13, 2012
April 30, 2012
November 19, 2014
April 2010
April 2012   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01587937 on ClinicalTrials.gov Archive Site
  • 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)
  • 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.
  • 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.
  • 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) ]
Same as current
Not Provided
Not Provided
 
Hospital Wide Roll-Out of Antimicrobial Stewardship
Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Bacterial Infections
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.
  • Experimental: Antibiotic stewardship intervention
    Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial
    Intervention: Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19220
20000
April 2012
April 2012   (Final data collection date for primary outcome measure)

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: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01587937
416-2009
No
Not Provided
Not Provided
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Ontario Ministry of Health and Long Term Care
Principal Investigator: Nick Daneman Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP