Implementation and Feasibility of a Clinical Decision Support System for Early Mobilization in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Protocol Adherence Rate
研究概览
简要总结
This study aims to evaluate the feasibility, safety, and user acceptability of a tablet- and smartphone-based Clinical Decision Support System (CDSS) designed to guide early mobilization for patients with severe neurological conditions in the intensive care unit (ICU). The CDSS standardizes safety screening across neurological, physiological, and device-related domains and provides graded mobility recommendations from Level 0 (passive range of motion) to Level 10 (independent ambulation).
The single-center, single-arm feasibility study will be conducted over six months in neurosurgical and trauma ICUs. Adult patients (≥18 years) with traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or acute ischemic stroke will be included. Primary outcomes include protocol adherence, data completeness, and user satisfaction (System Usability Scale). Secondary outcomes include time to first mobilization, maximum mobility level achieved, and adverse event incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) admitted to the neuro-ICU or trauma ICU.
- •Diagnosis of acute neurological conditions, including traumatic brain injury (TBI), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or acute ischemic stroke (AIS).
- •Hemodynamically stable and deemed eligible for rehabilitation evaluation.
- •Expected ICU stay ≥48 hours.
排除标准
- •Pre-existing severe physical disability (modified Rankin Scale ≥4 before admission).
- •Unstable intracranial pressure or craniectomy with active cerebrospinal fluid leakage.
- •Unstable fractures or contraindications for mobilization as determined by the attending physician.
- •Palliative care status or do-not-resuscitate (DNR) orders.
- •Patients unable to participate in mobilization assessment due to medical instability or family refusal.
结局指标
主要结局
Protocol Adherence Rate
时间窗: From ICU admission to ICU discharge (approximately up to 30 days).
The proportion of ICU patient-days in which the mobilization activity executed by the therapist matches the mobility level recommended by the Clinical Decision Support System (CDSS). An adherence rate of ≥80% will be considered acceptable implementation fidelity.
Data Completeness Rate
时间窗: Throughout the 6-month study implementation period.
The proportion of required data fields accurately completed within the CDSS interface. A data completeness rate of ≥90% will indicate adequate system usability and workflow compliance.
User Acceptability (System Usability Scale Score)
时间窗: Assessed at the end of the 6-month study period.
The mean System Usability Scale (SUS) score obtained from ICU clinicians after using the CDSS for at least 4 weeks. A mean score ≥70 will be considered satisfactory usability. The System Usability Scale (SUS) is a validated 10-item questionnaire with scores ranging from 0 to 100. Higher scores indicate better usability and greater user acceptability. A score of 70 or above is generally considered acceptable usability.
次要结局
- Time to First Mobilization at Level ≥2(From ICU admission until the first mobilization (up to 30 days).)
- Highest Mobility Level Achieved by Day 5(First 5 days after ICU admission.)
- Highest Mobility Level at ICU Discharge(From ICU admission to ICU discharge (approximately up to 30 days).)
- Incidence of Mobilization-Related Adverse Events(From the first mobilization session until ICU discharge (up to 30 days).)