Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB): A Stepped Wedge Clinical Trial Evaluating the Effectiveness of a Centralized S. Aureus Management Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,542
- 试验地点
- 202
- 主要终点
- Adherence to quality-of-care indicators
研究概览
简要总结
Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.
Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.
The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years at the time of hospital admission
- •Confirmed S. aureus bacteremia by blood culture performed at a laboratory in Alberta, Canada
- •Admitted to a designated acute care site in Alberta, Canada
排除标准
- •The treating team believes death is imminent or inevitable .
- •GCD are C-level within 48 hours of admission.
- •The patient is transferred in from an out-of-province acute care center with a pre-existing SAB diagnosis.
研究组 & 干预措施
Standard of care
OPTIMUS-SAB care pathway
Province-wide real time automated notifications of new SAB cases will be established and delivered to a centralized SAB care team electronically through Connect Care. The centralized SAB care team consists of a SAB clinical coordinator, ID specialists and other ad hoc representation depending on patient needs. Following patient chart review, the centralized SAB care team contacts the most responsible physician (MRP) to provide preliminary recommendations to optimize care, both verbally and in written format, facilitated by Connect Care (Alberta Health Services electronic medical record).
干预措施: OPTIMUS-SAB clinical care pathway (Other)
结局指标
主要结局
Adherence to quality-of-care indicators
时间窗: Within 90 days
Defined as: 1. ID involvement and time to ID involvement, defined by the presence of an ID consult note and/or recommendations in the chart. 2. Repeat blood cultures, to document clearance of bacteremia, within 72 hours from the last positive blood culture. 3. Guideline-concordant empiric antibiotic administered and time to receipt. 4. Guideline concordant definitive antibiotic administered and time to receipt. 5. Therapeutic drug monitoring of patents treatments with vancomycin. 6. Appropriate dose adjustment of antimicrobials based on renal function according to local guidelines. 7. Echocardiogram (transthoracic or transesophageal) performed within 72 hours of diagnosis. 8. Source control achieved. 9. Appropriate duration of antibiotic therapy ordered and delivered.
次要结局
- In hospital mortality(90 days)
- Costing evaluation(One year)
- Implementation evaluation(3 years)
- Hospital re-admission rates(90 days)
- All-cause mortality(180 days)
- Length of stay(180 days maximum)