Hospital Wide Roll-Out of Antimicrobial Stewardship

NCT01587937 | Completed

• 1 other identifier: 416-2009
• Study Type: interventional
• Target: 19,220
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)

  patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)

• Costs of antibiotic therapy ($) per patient day

  patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)

• Hospital-acquired Clostridium difficile infection.

  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)

Study Arms (2)

Antibiotic stewardship intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics OTHER

See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.

Antibiotic stewardship intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• patient being followed by the infectious diseases consult service

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (2)

• 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.

  PMID: 22479110 BACKGROUND

• 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.

  PMID: 22418630 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections; Clostridium Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Gram-Positive Bacterial Infections

Study Officials

• Nick Daneman

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 30, 2012
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

CA (1)