Implementation of Coordinated Spontaneous Awakening and Breathing Trials Using Telehealth-Enabled, Real-Time Audit and Feedback for Clinician Adherence: A Type II Hybrid Effectiveness-Implementation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13,400
- 试验地点
- 22
- 主要终点
- Ventilator-free days to day 28
研究概览
简要总结
The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.
详细描述
Sedation and analgesia are utilized with invasive mechanical ventilation (IMV) to improve patient comfort and synchrony with the mechanical ventilator. Prolonged sedation, however, may result in increased time on IMV and increased risk for ventilator associated pneumonia, delirium, and poor long-term cognitive outcomes. Daily interruptions in sedation [spontaneous awakening trials (SAT)] coordinated with daily spontaneous breathing trials (SBT) reduce mortality, increase ventilator free days, decrease intensive care unit (ICU) length of stay, and reduces ventilator-associated events. Coordination of spontaneous awakening and breathing trials (C-SAT/SBT), however, are underutilized due to significant barriers to implementation and adherence. This cluster-randomized hybrid implementation/effectiveness trial will compare C-SAT/SBT adherence and clinical outcomes in the presence of traditional audit and feedback implementation strategies alone or augmented with a novel Telehealth-Enabled, real-time Audit and feedback for Clinician adHerence ("TEACH") implementation strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ventilator-free days to day 28
时间窗: 28 days
ventilator-free days to day 28
Adherence to C-SAT/SBT
时间窗: intubation to extubation - an average of 5 days
Fraction of eligible days on which coordinated spontaneous awakening trial and spontaneous breathing trial completed.
次要结局
- 30-day Mortality(30 days)
- 90-day Mortality(90 Days)
- Reintubation(intubation to extubation - an average of 5 days)
- Hospital Length of Stay(Through hospital discharge, an average of 10 days)
- New ventilator-associated pneumonia(Through hospital discharge, an average of 10 days)
- ICU Length of Stay(Through hospital discharge, an average of 10 days)
- Unintentional Extubation(intubation to extubation - an average of 5 days)
