Integration of Machine Learning and Clinical Decision Support to Prevent Postoperative Delirium in Patients With Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7,412
- 试验地点
- 1
- 主要终点
- 4AT Delirium Score
研究概览
简要总结
Among patients with cognitive impairment (CI) that undergo surgery, the risk for developing postoperative delirium (POD) is high (50%) and associated with further morbidity and mortality. Yet, 30-40% of POD cases are preventable with perioperative management. This randomized pragmatic clinical trial aims to assess incidence of POD in adult surgical patients with CI, as well as provider adherence to a set of 12 perioperative best practice recommendations for perioperative management. Electronic health record (EHR) data will be used to identify patients as high risk for developing POD and clinical decision support (CDS) prompts within the EHR will display best practices. Cases will be randomized to either the control group, usual care or the intervention which includes the high-risk alert and best practice prompts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a history of cognitive impairment (CI) undergoing surgery at the Mount Sinai Health System.
- •Attending physicians, resident physicians, and nurse anesthetists at the Mount Sinai Health System receiving CDS alerts during EHR system implementation.
排除标准
- •Patients will be excluded if this not their first surgery since study start, if they do not have cognitive impairment based on EHR data, or if the surgery is for organ donation.
- •There will be no exclusion criteria for providers or historical controls.
研究组 & 干预措施
Clinical Decision Support
Clinical decision support alerts in the electronic health record directed towards anesthesiologists caring for patients with preexisting cognitive impairment.
干预措施: Clinical Decision Support (Other)
Standard of Care
No clinical decision support will appear, and standard of care procedures will take place.
结局指标
主要结局
4AT Delirium Score
时间窗: Postoperative day 7
Postoperative Delirium measured using the 4 A's Test (4AT) delirium assessment documentation. The 4AT is a commonly used tool that identifies the presence/absence of Postoperative Delirium (POD). It consists of 4 sections; alertness, AMT4: Abbreviated Mental Test -4, attention, and acute change of fluctuating course. The 4AT is scored from 0-12, with higher score indicating poorer health outcomes. Scoring: 4 or above: possible delirium +/- cognitive impairment 1-3: possible cognitive impairment 0: delirium or severe cognitive impairment unlikely (but delirium still possible if \[4\] information incomplete)
次要结局
- Number of Participants Where Perioperative Best Practices for Intervention Was Performed(Day 1)
- Mean Arterial Pressure >65 mmHg(Day 1)
- Age Adjusted Minimum Alveolar Concentration (MAC)(Day 1)
研究者
Ira Hofer
Associate Professor
Icahn School of Medicine at Mount Sinai