Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients.

Background. Stroke Units reduce mortality and dependence in acute stroke patients regardless of stroke subtype, severity, age or sex. However, in Andalusia, only a small proportion of acute stroke patients are admitted to an SU; many patients who are not candidates for mechanical thrombectomy remain hospitalized in non-SU wards of regional hospitals, with limited access to structured stroke-specific multidisciplinary care.

Rationale. Telemedicine-supported organizational models have shown promise to bridge the access gap for time-sensitive stroke care. The Virtual Stroke Unit (VSU) is a novel organizational model that combines (i) standardized monitoring boxes in non-SU hospitals with predefined nursing protocols, (ii) a daily synchronous joint visit between the local team and the reference SU team via the CATI telemedicine platform, and (iii) structured remote follow-up and discharge planning. The VSU model has not been formally evaluated in a comparative prospective study.

Objectives. Primary: to test whether VSU care is non-inferior to conventional SU care for 3-month functional outcome (mRS) in patients with acute stroke not eligible for mechanical thrombectomy. Secondary: to evaluate safety (in-hospital complications, mortality), efficiency (length of stay, inter-hospital transfers), patient and provider satisfaction (TUQ/TSQ/TMPQ), 1-year functional outcome and recurrence, and cost-effectiveness.

Design. Prospective multicenter cohort study with two parallel groups:

* VSU group: consecutive eligible patients admitted to Hospital de Riotinto (Huelva) or Hospital San Juan de Dios del Aljarafe (Bormujos), receiving structured remote care from the CATI/Virgen Macarena stroke team.
* Conventional SU group (control): consecutive eligible patients admitted to the Stroke Unit of Hospital Universitario Virgen Macarena (Sevilla), without telemedicine support.

Sample size. 363 patients per group (726 total) to detect non-inferiority of VSU vs SU on the primary outcome, with a non-inferiority margin of 10%, 80% power, two-sided α = 5%, and an estimated 15% loss to follow-up.

• (Healthcare organizational model) (Other): Structured multidisciplinary stroke care delivered remotely from the reference Stroke Unit (Hospital Universitario Virgen Macarena) to non-SU hospitals (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe). Components: (i) standardized stroke monitoring boxes with predefined nursing protocols; (ii) synchronous joint assessment between local team and reference stroke neurologist/nurse via CATI videoconferencing on day 1 of admission; (iii) structured remote follow-up during hospitalization; (iv) standardized teleconsultation discharge report; (v) protocolized scheduled remote re-assessment at 1 week, 1 month, 3 months and 12 months.
• Conventional care (Other): Bundle of conventional stroke unit care

Primary outcomes

• Death or dependency at 90 days (modified Rankin Scale 3-6) [90 days from index admission]: Proportion of participants who are dead or functionally dependent (mRS 3-6) at 90 ± 15 days post-admission. The mRS is a 7-level clinician-rated scale (0 = no symptoms; 6 = death); the 3-6 range is the canonical measure of stroke-unit effectiveness (avoidance of death or dependency). Non-inferiority of VSU versus conventional SU care is declared if the upper limit of the one-sided 95% confidence interval for the between-group difference does not exceed the pre-specified +10 percentage-point margin.

Secondary outcomes

• Adherence to the stroke-unit care quality bundle [Index admission]: Proportion of participants receiving a predefined stroke-unit care bundle during the index admission, equivalent to conventional SU standards: dysphagia screening before oral intake, early mobilization, neurological/vital-sign monitoring protocol, antithrombotic therapy within 48 h when indicated, and structured multidisciplinary assessment. Measures whether VSU care reproduces the quality of conventional stroke-unit care.
• In-hospital complications (composite safety endpoint) [Index admission (median 7-10 days)]: Composite of in-hospital medical complications: symptomatic intracranial hemorrhage, early neurological worsening (NIHSS ≥ 4 points), aspiration pneumonia, deep vein thrombosis, urinary tract infection, in-hospital death.
• Etiological classification (TOAST) [3 months]: Distribution of TOAST etiological categories in ischemic strokes (large-artery atherosclerosis, cardioembolic, small-vessel, other determined, undetermined).
• Adherence to secondary prevention [3 and 12 months]: Proportion of participants on guideline-concordant secondary prevention (antithrombotic therapy, antihypertensives, statins, anticoagulation if indicated) at 3 and 12 months.
• Length of hospital stay [Index admission]: Length of index admission in days, from admission to discharge

Sex: All, ages: 18 Years to any

Inclusion Criteria

* Age ≥ 18 years.
* Diagnosis of acute stroke (ischemic or hemorrhagic) confirmed by clinical assessment and neuroimaging (CT and/or MRI) within 24 hours of symptom onset or last-seen-well.
* Not a candidate for mechanical thrombectomy according to current clinical guidelines.
* Admission to a participating hospital (Hospital de Riotinto, Hospital San Juan de Dios del Aljarafe, or Hospital Universitario Virgen Macarena).
* Signed informed consent by the participant or legal representative. Exclusion Criteria
* Pre-stroke modified Rankin Scale (mRS) ≥ 4.
* Life expectancy < 6 months due to non-stroke comorbid conditions.
* Inability to complete protocolized follow-up (geographical, social, or clinical reasons).
* Concurrent participation in another interventional clinical trial that may affect study endpoints.
* Refusal to provide informed consent.

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