Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,220
- 试验地点
- 1
- 主要终点
- Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to the medical/surgical services will be included in statistical analysis of program evaluation. The inclusion/
排除标准
- •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
研究组 & 干预措施
Antibiotic stewardship intervention
Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial
干预措施: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics (Other)
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.
结局指标
主要结局
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
时间窗: 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)
次要结局
- 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))
- Antibiotic susceptibility of gram negative bacterial isolates(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))
- Costs of antibiotic therapy ($) per patient day(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))