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Hospital Wide Roll-Out of Antimicrobial Stewardship

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bacterial Infections focused on measuring Antibiotic stewardship., Clostridium difficile infection., Antibiotic resistance.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antibiotic stewardship intervention

Control

Arm Description

Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Costs of antibiotic therapy ($) per patient day
Based on acquisition costs for each agent.
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.
Antibiotic susceptibility of gram negative bacterial isolates

Full Information

First Posted
April 13, 2012
Last Updated
November 17, 2014
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Ontario Ministry of Health and Long Term Care
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1. Study Identification

Unique Protocol Identification Number
NCT01587937
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Antibiotic stewardship., Clostridium difficile infection., Antibiotic resistance.

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic stewardship intervention
Arm Type
Experimental
Arm Description
Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics
Intervention Description
See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.
Primary Outcome Measure Information:
Title
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
Description
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)
Time Frame
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Secondary Outcome Measure Information:
Title
Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)
Description
-Definition as per primary outcome, but can include any antibiotic (not just those broadspectrum agents targeted by the intervention)
Time Frame
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Title
Costs of antibiotic therapy ($) per patient day
Description
Based on acquisition costs for each agent.
Time Frame
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Title
Hospital-acquired Clostridium difficile infection.
Description
Cases of Clostridium difficile infection deemed to have been acquired during the current hospital stay by prospective Infection Prevention & Control surveillance team.
Time Frame
patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Title
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)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Daneman
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22479110
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.
Results Reference
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PubMed Identifier
22418630
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.
Results Reference
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Hospital Wide Roll-Out of Antimicrobial Stewardship

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