Continuous Vital Sign Monitoring in a Norwegian Hospital Surgical Ward: A Multi-Method Study of Patient Outcomes, Patient Safety Culture, and Nursing Staff Experiences
| Registry | NCT07690267 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 9600 (Estimated) |
| Sponsor | University Hospital, Akershus (Other); collaborators: Norwegian University of Science and Technology |
| Conditions | Patient Monitoring, Wearable Devices, Telemonitoring, Patient Safety, Patient Deterioration, Nurses, Healthcare Professionals, Work-related Outcomes, Implementation, Implementation Research |
| Interventions | Continuous Vital Sign Monitoring (CVSM) (Other) |
| Dates | start 2025-09-01, primary completion 2026-10-01 (estimated), completion 2026-10-01 (estimated), first posted 2026-07-08, last updated 2026-07-09 |
| Locations | 1 site in Norway |
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All trials for Patient Monitoring All trials for Wearable Devices All trials of Continuous Vital Sign Monitoring (CVSM)
Unsafe patient care remains a major contributor to global morbidity and mortality. In surgical wards, postoperative patients are typically monitored intermittently using the National Early Warning Score (NEWS-2), leaving periods during which clinical deterioration may go undetected. Continuous vital sign monitoring (CVSM) using wearable sensors offers the potential for earlier identification of deterioration compared with intermittent assessments.
CVSM was introduced in a hospital ward as part of a hospital-initiated pilot implementation and is used alongside standard monitoring with NEWS-2. The purpose of the study is to evaluate this implementation.
This observational study uses a pragmatic, quasi-experimental, multi-method, longitudinal design. The overall aims of the study are to evaluate the impact of CVSM implementation on patient outcomes, to explore healthcare professionals' perceptions of patient safety culture, turnover intention and pleasure of work, and to describe their experiences with implementation.
Unsafe care is a major contributor to global morbidity and mortality. In surgical wards, postoperative patients are typically monitored intermittently using the National Early Warning Score (NEWS-2), which may leave periods during which changes in vital signs go undetected, potentially increasing the risk of clinical deterioration. Continuous vital sign monitoring (CVSM) using wearable sensors may enable earlier detection of deterioration compared with intermittent monitoring.
This study evaluates the implementation of CVSM using 16 wearable sensors in a 29-bed gastro-surgical ward beginning in September 2025. CVSM is based on wearable sensors that continuously monitor patients' respiratory rate, heart rate, and oxygen saturation. The system transfers data to the electronic health record, and alerts are generated when predefined thresholds are exceeded and delivered to nursing staff via smartphones and workstation monitors. CVSM is implemented in addition to usual care, including intermittent NEWS-2 monitoring, in accordance with hospital protocol.
The intervention was implemented as part of a hospital-initiated pilot programme that was supported by hospital management and aimed to evaluate the feasibility and potential effects of broader CVSM adoption. The intervention ward was selected by the hospital for pragmatic reasons, based on managers' agreement to implement CVSM. Implementation was overseen by a hospital-appointed project manager. Members of the research team participated in implementation meetings and provided input on potential implementation strategies. However, responsibility for implementation decisions remained with hospital management and the clinical departments, and implementation was primarily guided by clinical priorities and operational constraints within the hospital. The primary role of the research team was to support and conduct the empirical evaluation of the intervention and its implementation.
It is hypothesised that CVSM may enable earlier detection of patient deterioration compared with intermittent monitoring alone and thereby influence patient outcomes. It is also hypothesised that CVSM may influence healthcare professionals' perceptions of patient safety culture, turnover intention, and work-related well-being. The study will further generate knowledge about healthcare professionals' experiences with the implementation.
While data collection for the studies on patient safety culture and nurses' experiences with implementation has started, the patient outcome study is currently awaiting a decision from the Norwegian Directorate of Health. Data collection for this study has not yet commenced. The studies on patient safety culture and nurses' experiences with implementation have been preregistered in the Open Science Framework (OSF).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention ward | Other: Continuous Vital Sign Monitoring (CVSM) | All patients admitted to the gastro-surgical ward during the 12-month implementation of continuous vital sign monitoring (CVSM). Healthcare professionals (physicians, nursing assistants, and registered nurses) working predominantly in the intervention ward. | |
| Control group | All patients admitted to the same gastro surgical ward will be its own control group 1 year before the intervention. Patients received standard care before the intervention. This means that relevant outcomes during the implementation (2026) is compared to the same outcomes before the intervention (i.e., 2024) in the same ward. | ||
| Non-equivalent comparison group | All patients admitted to a non-equivalent comparison ward for the period spanning from January 1, 2024, to January 1, 2025, and from October 1, 2025, to October 1, 2026, during which CVSM was not implemented. Healthcare professionals (physicians, nursing assistants, and registered nurses) working predominantly in a comparable gastro-surgical ward at the same hospital during the 12-month implementation period of CVSM in the intervention ward. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Patients aged 18 years or older admitted to the gastro-surgical ward. * Healthcare professionals aged 18 years or older employed in the participating wards for survey participation. * Nursing staff with at least 6 months of work experience and experience using CVSM for participation in qualitative focus group interviews. Exclusion Criteria: * Patients with delirium. * Patients with cognitive impairment interfering with sensor use. * Patients who decline participation. * Patients with allergy to electrode adhesives.
| Facility | City | Country | Status |
|---|---|---|---|
| Akershus University Hospital HF | Lørenskog, Akershus | Norway | Recruiting |