Hospital Wide Roll-Out of Antimicrobial Stewardship

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587937
• Other study ID #: 416-2009
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: November 17, 2014
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19220
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Antibiotic susceptibility of gram negative bacterial isolates		patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)	No