About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Patients with delirium.
Patients with cognitive impairment interfering with sensor use.
Patients who decline participation.
Patients with allergy to electrode adhesives.
Trial population
The study population includes adult patients admitted to a gastro-surgical ward before and after implementation of continuous vital sign monitoring (CVSM), as well as adult patients admitted to a non-equivalent comparison ward at the same Norwegian teaching hospital. The study population also includes healthcare professionals working in these wards.
Trial design
Cohort
Other
Treatments tested in this trial
Continuous Vital Sign Monitoring (CVSM)
Other interventionThe intervention consists of continuous vital sign monitoring (CVSM) using wearable sensors applied to patients. A total of 16 sensors are implemented in a 29-bed gastro-surgical ward. The system continuously records patients' vital signs and transfers data to the electronic health record. Alerts are generated when predefined thresholds are exceeded and are delivered to nursing staff via smartphones and workstation monitors. The intervention is implemented in addition to usual practice with intermittent monitoring using the National Early Warning Score (NEWS-2), according to hospital protocol. Nursing staff receive training prior to implementation, and clinical responses to alerts are managed in accordance with hospital procedures. The intervention was implemented from September 2025 and continues during the study period.
Treatment groups
Trial outcomes
Primary outcomes
NEWS-2 Associated with RRT Activation
National Early Warning Score 2 (NEWS2) associated with rapid response team (RRT) activation. NEWS2 is a physiological deterioration score ranging from 0 to 20 points. Higher scores indicate greater physiological deterioration and worse clinical status. According to hospital protocol, RRT consultation is recommended at NEWS2 ≥7. NEWS2 at the time of RRT activation will be assessed.
Patient Safety Culture (N-HSOPSC 2.0)
Healthcare professionals' perceptions of patient safety culture measured as changes in the ten composite dimensions and two single-item measures of the Norwegian Hospital Survey on Patient Safety Culture (N-HSOPSC 2.0). Responses are recorded using 5-point Likert scales ranging from 1 to 5. Higher scores indicate more positive perceptions of patient safety culture.
Nursing Staff Experiences with CVSM
Nursing staff experiences with the implementation and perceived usefulness of continuous vital sign monitoring (CVSM) for patient safety, explored through qualitative focus group interviews. This is a qualitative outcome measure and no numerical score will be calculated.
Secondary outcomes
Rapid Response Team (RRT) Activation
Number of Rapid Response Team (RRT) activation
Unplanned Transfers to Higher Level of Care
Number of unplanned transfers to a higher level of care (intensive care unit or postoperative care unit)
NEWS-2 at Time of Clinical Deterioration
National Early Warning Score 2 (NEWS2) measured at the time of unplanned transfer to a higher level of care. NEWS2 is a physiological deterioration score ranging from 0 to 20 points. Higher scores indicate greater physiological deterioration and worse clinical status.
Hospital Length of Stay
Total hospital length of stay (hours)
Locations
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Sponsors and contacts
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University Hospital, Akershus
Lead sponsor
Norwegian University of Science and Technology
Collaborator