Clinical Decision Support System for Early Mobilization in the Neuro-ICU

National Taiwan University Hospital25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury Intracerebral Hemorrhage Subarachnoid Hemorrhage, Spontaneous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Protocol Adherence Rate

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.

Time frame: From ICU admission to ICU discharge (approximately up to 30 days).

Data Completeness Rate

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.

Time frame: Throughout the 6-month study implementation period.

User Acceptability (System Usability Scale Score)

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.

Time frame: Assessed at the end of the 6-month study period.

Secondary Outcomes

Time to First Mobilization at Level ≥2

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.

Time frame: From ICU admission until the first mobilization (up to 30 days).

Highest Mobility Level Achieved by Day 5

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.

Time frame: First 5 days after ICU admission.

Highest Mobility Level at ICU Discharge

The highest mobility level reached before ICU discharge, as recorded by the CDSS daily log.

Time frame: From ICU admission to ICU discharge (approximately up to 30 days).

Incidence of Mobilization-Related Adverse Events

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).

Time frame: From the first mobilization session until ICU discharge (up to 30 days).