The WARD-EU study is a multinational, multicentric, mixed-methods observational investigation conducted across four European countries. The study is designed to explore variation in hospital patient monitoring practices and to evaluate the implementation potential of an algorithm-based continuous monitoring system across different healthcare settings.
The study consists of two sequential phases. Phase 1 (pre-implementation) focuses on mapping existing monitoring practices for adult patients admitted for medical or surgical conditions with an expected hospital stay of at least two days. Data will be collected using structured questionnaires administered to patients and nursing staff to characterize monitoring frequency, workflows, perceived safety, and user experience within participating healthcare systems.
Phase 2 (post-implementation) evaluates the integration of the WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System) into routine clinical practice. WARD-CSS combines wearable wireless sensors for continuous vital sign monitoring with an application incorporating clinically modelled algorithms designed to detect early signs of respiratory and circulatory deterioration while reducing unnecessary alerts. During this phase, the system will be used for in-hospital monitoring and, where feasible, extended to post-discharge home monitoring.
Data collection in Phase 2 will include questionnaires from healthcare professionals and patients to assess usability, feasibility, and acceptability of the system, as well as descriptive analysis of system-generated vital sign data, monitoring adherence, and measurement frequency. Complications occurring within 30 days following hospital discharge will be recorded. Qualitative feedback will be used to identify facilitators and barriers to implementation, including technological challenges, workflow integration, and patient compliance, particularly in home-monitoring settings.
The study will enroll adult patients and healthcare professionals from participating centers. Participants may be involved during hospitalization and, for selected patients, during home monitoring following discharge, with follow-up up to 30 days. Data will be analyzed descriptively using appropriate parametric and non-parametric methods to identify patterns and variability across countries and care settings.
The study will be conducted in accordance with the Clinical Study Protocol, ICH-GCP, ISO 14155, the Declaration of Helsinki, and applicable national regulatory requirements. Ethics approval will be obtained from relevant committees in all participating countries, and data handling will comply with the General Data Protection Regulation and local data protection laws.
