Acute Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Spontaneous, Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
DEVICEClinical Decision Support System (CDSS) for Early Mobilization
The CDSS is a tablet- and smartphone-based system designed to standardize safety screening and guide early mobilization decisions for neuro-ICU patients. It provides graded mobility level recommendations based on neurological, physiological, and device-related parameters.
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Adherence Rate | 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 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Mobilization at Level ≥2 | From ICU admission until the first mobilization (up to 30 days). | The number of days from ICU admission to the first mobilization episode reaching Level 2 or higher (e.g., edge-of-bed sitting or above) as determined by the CDSS mobility scale. |
| Highest Mobility Level Achieved by Day 5 | First 5 days after ICU admission. | The maximum mobility level achieved by each participant within the first three ICU days, based on the modified 0-10 ICU Mobility Scale recorded through the CDSS. Modified ICU Mobility Scale (0-10) ranges from 0 to 10, with higher scores indicating greater mobility and functional independence. |
| Highest Mobility Level at ICU Discharge | From ICU admission to ICU discharge (approximately up to 30 days). | The highest mobility level reached before ICU discharge, as recorded by the CDSS daily log. |
| Incidence of Mobilization-Related Adverse Events | From the first mobilization session until ICU discharge (up to 30 days). | The frequency and type of adverse events occurring during CDSS-guided mobilization, including hemodynamic instability (MAP \<65 mmHg or SBP drop \>20 mmHg), oxygen desaturation (SpO₂ \<90% for \>30 seconds), or device dislodgement (unplanned removal of EVD, central line, or ventilator tubing). |
Countries
Taiwan
Outcome results
None listed