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

Official title

Virtual Stroke Units Versus Conventional Stroke Unit Care in Non-Thrombectomy-Candidate Patients: A Non-Inferiority Prospective Cohort Study

Overview

Stroke is the leading cause of acquired disability in adults and a major cause of mortality worldwide; in Spain, Andalusia shows the highest stroke-related mortality rate. Comprehensive Stroke Units (SU) are the gold-standard organizational model for acute stroke care; however, only a fraction of patients have direct access to an SU, particularly those not eligible for mechanical thrombectomy who are admitted to regional or district hospitals without on-site SU capacity. The Virtual Stroke Unit (VSU) concept extends specialized stroke care to non-SU hospitals by combining standardized in-hospital monitoring boxes with synchronous remote multidisciplinary assessment by a stroke neurologist and stroke nurse from a reference center, via the regional telemedicine platform (CATI). This prospective, multicenter, non-inferiority cohort study compares effectiveness, safety, and feasibility of VSU care versus conventional SU care in patients with acute ischemic or hemorrhagic stroke who are not candidates for mechanical thrombectomy. Recruitment targets 363 patients per arm (726 total). The primary outcome is death or dependency at 3 months (modified Rankin Scale 3-6) - the canonical measure of stroke-unit effectiveness - with functional independence (mRS 0-2), adherence to the stroke-unit care quality bundle, safety, mortality, recurrence, length of stay, satisfaction (TUQ/TSQ/TMPQ) and cost-effectiveness as secondary outcomes.

Detailed description

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.

Interventions

• Other (Healthcare organizational model)
  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 hospitalizati
• Other Conventional care
  Bundle of conventional stroke unit care

Primary outcome measures

• Death or dependency at 90 days (modified Rankin Scale 3-6) [Time frame: 90 days from index admission]

Secondary outcome measures (5)

• Adherence to the stroke-unit care quality bundle [Time frame: Index admission]
• In-hospital complications (composite safety endpoint) [Time frame: Index admission (median 7-10 days)]
• Etiological classification (TOAST) [Time frame: 3 months]
• Adherence to secondary prevention [Time frame: 3 and 12 months]
• Length of hospital stay [Time frame: Index admission]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 1 center

• Hospital San Juan de Dios, Bormujos — Seville

Publications

• Behrens JR, Kaffes M, Aigner A, Herm J, Erdur H, Siepmann T, Barlinn J, Hubert G, Wiestler H, Gumbinger C, Ranta A, von Weitzel-Mudersbach P, Rocco A, Hofmann-Shen C, Muhn F, Liman T, Rozanski M, Litmeier S, Riegler C, Hellwig S, Geran R, Koschutzke L, Ditsche H, Kotlarz-Bottcher M, Kinze S, Audebert H. Teleneurology vs On-Site Neurology Consultation for Postadmission Hospital Care of Stroke. JAMA PMID 41941227
• Martins SO, Feigin V, Carbonera LA, de Souza AC, Secchi TL, Nair B, Sposato LA, Liu L, Molina CA, Nogueira RG. Integrating Digital Health Into Stroke Policies. Stroke. 2026 Jun;57(6):1796-1809. doi: 10.1161/STROKEAHA.125.050451. Epub 2026 Mar 30. PMID 41906872
• Barragan-Prieto A, Perez-Sanchez S, Moniche F, Moyano RV, Delgado F, Martinez-Sanchez P, Moya M, Oropesa JM, Minguez-Castellanos A, Villegas I, Alvarez Soria MJ, Tamayo Toledo JA, de la Cruz Cosme C, Canto Neguillo R, Herrerias Esteban JM, Montero Cobos DJ, Moreno Munoz JA, Gonzalez A, Montaner J. Express improvement of acute stroke care accessibility in large regions using a centralized telestrok PMID 36082245

Identifiers

NCT: NCT07635498 · PI24/01807

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗