TraceBook: the Clinical Proof of Concept on the Intensive Care.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 408
- 试验地点
- 2
- 主要终点
- Checked items
研究概览
简要总结
The effectiveness of current checklists is hampered by lack of acceptance and compliance. Recently, a new type of checklist with dynamic properties has been created to provide more specific checklist items for each individual patient. The proof of concept of this dynamic clinical checklist (DCC; BJA 2017 (DOI: 10.1093/bja/aex129)) was tested in a simulation trial with improved outcomes and high acceptance scores. The purpose of this study is to investigate if the outcomes of this real-life clinical proof of concept study are similar with the outcomes of the simulation trial for the intensive care unit (ICU) ward.
详细描述
Method A prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study.
The before period will be used as control group in which ward rounds and nurse handovers will be observed by the investigators for two months. Then TraceBook will be introduced and clinicians, ICU doctors and nurses, will be able to use checklists of TraceBook for ward rounds, their shifts and handovers in which they will be observed for two months. The goal is at least 120 observations per period.
Endpoints The primary outcome is the percentage of items that were checked per ward rounds and nurse handovers during the before and the after implementation period. Secondary outcomes will be clinical outcomes of admitted patients, pharmacist specific outcomes, specific checkable item related outcomes, and user experience and acceptance scores.
Hypothesis TraceBook, with the use of digital dynamic checklists, improves compliance to care processes on the intensive care with a high user acceptance score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physicians working on the ICU
- •All admitted patients on the ICU during the study periods.
排除标准
- •Physicians objecting participation in the trial
结局指标
主要结局
Checked items
时间窗: 24 hours (each day)
The percentage of daily checked checkable items overall and items requiring an intervention per patient.
次要结局
- Pharmacists' interventions(4 months)
- Incorrect prescribed proton pump inhibitors(4 months)
- Opiates use(4 months)
- User experience(6 months)
- Ventilator days(9 months)
- Sedation days(9 months)
- Number of gastro-intestinal bleedings(4 months)
- Incorrect prescribed anticoagulation or thrombosis prophylaxis.(4 months)
- Central-venous-catheter-related bloodstream infections.(4 months)
- Spontaneous breathing trials(4 months)
- Sedation wake up calls(4 months)
- Antibiotics use(4 months)
- Complication registration(4 months)
- Length of stay(9 months)
- Daily intensive care medication alerts(4 months)
- Ventilator and hospital associated pneumonia on the intensive care.(4 months)
- Incorrect prescribed selective digestive decontamination(4 months)
- Energy deficit(4 months)
- User acceptance(6 months)
- Hedonic and pragmatic quality(6 months)
- Intravenous sedatives use(4 months)
- Automatically checked items(4 months)
- User experience outcomes(6 months)
- Mortality(9 months)
研究者
Ashley De Bie
Physician-scientist
Catharina Ziekenhuis Eindhoven