Clinical Deterioration, Patient Deterioration, Patient Monitoring
Conditions
Keywords
monitoring, Post-discharge monitoring, Clinical deterioration
Brief summary
Hospital patient monitoring in Europe is often intermittent, which can delay detection of clinical deterioration during hospitalization and after discharge. The WARD-EU study aims to describe current monitoring practices and to evaluate the feasibility, acceptability, and usability of the WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System), an algorithm-based continuous monitoring system. The study seeks to assess whether WARD-CSS can be integrated into routine hospital and post-discharge care to support earlier detection of patient deterioration and improved patient monitoring.
Detailed description
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.
Interventions
DEVICEWARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System)
Participants in Phase 2 will be monitored using the WARD-CSS system, which combines wearable wireless vital sign sensors with an application that applies clinically modeled algorithms to detect early signs of respiratory and circulatory deterioration. The system provides real-time data to healthcare professionals, reduces unnecessary alerts, and supports both in-hospital and, where feasible, post-discharge home monitoring.
Sponsors
Eske Kvanner Aasvang
Rigshospitalet, Denmark
University Medical Center Groningen, Netherland
NOVA Medical School
Jagiellonian University
Bispebjerg Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults (≥18 years) admitted to hospitals due to medical or surgical conditions with an expected hospital stay of at least two days. * Adults discharged from the hospital who are receiving home-based monitoring using WARD-CSS (Phase 2 only). * Willingness to participate and provide informed consent.
Exclusion criteria
* Patients with severe comorbidities (e.g., severe dementia) that preclude continuous monitoring. * Patients unwilling or unable to provide informed consent. * Patients unable to wear the monitoring equipment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of monitoring practices and WARD-CSS feasibility | From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort. | Implementation of the WARD-CSS continuous monitoring system will be evaluated using structured surveys administered to healthcare professionals and patients. Surveys include: Self-developed questionnaires for patients and healthcare professionals administered before and after implementation to assess perceived system performance, usability, workflow integration, and implementation challenges. mHealth App Usability Questionnaire (MAUQ) administered after implementation to assess usability (total and subscale scores calculated according to scoring guidelines; higher scores indicate better usability). Normalization Measure Development Questionnaire (NoMAD) administered after implementation to assess implementation integration into routine practice (total score calculated according to scoring guidelines; higher scores indicate greater normalization/integration). For each instrument, mean total scores will be reported based on their respective validated scoring systems. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient experience and usability | From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort. | Patient-reported comfort, perceived safety, and usability of monitoring will be assessed using structured self-developed questionnaires. Surveys will evaluate: * Physical comfort during monitoring * Perceived safety while being monitored * Ease of use and overall usability of the monitoring system Responses will be scored using predefined scales. Higher scores will indicate more positive patient experience (greater comfort, safety, and usability). Assessments will be conducted during standard monitoring practice (pre-implementation) and during WARD-CSS-supported monitoring (post-implementation), including home monitoring where applicable. |
Countries
Denmark, Netherlands, Poland, Portugal
Contacts
CONTACTEske K Aasvang, DMSci
CONTACTSharri S Mortensen, MD
STUDY_CHAIREske K Aasvang, DMSci
Rigshospitalet, Denmark
Outcome results
None listed