- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07690267
Continuous Vital Sign Monitoring in a Surgical Ward
Continuous Vital Sign Monitoring in a Norwegian Hospital Surgical Ward: A Multi-Method Study of Patient Outcomes, Patient Safety Culture, and Nursing Staff Experiences
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Gørill H. Birkeli, PhD
- Telefonnummer: +47 47304895
- E-mail: gobi@ahus.no
Studiesteder
-
-
Akershus
-
Lørenskog, Akershus, Norge, 1478
- Rekruttering
- Akershus University Hospital HF
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Intervention ward
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. |
The 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.
|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
NEWS-2 Associated with RRT Activation
Tidsramme: Up to 12 months after implementation
|
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.
|
Up to 12 months after implementation
|
|
Patient Safety Culture (N-HSOPSC 2.0)
Tidsramme: Baseline, 5 months, and 12 months after implementation
|
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.
|
Baseline, 5 months, and 12 months after implementation
|
|
Nursing Staff Experiences with CVSM
Tidsramme: Approximately 6 months after implementation
|
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.
|
Approximately 6 months after implementation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rapid Response Team (RRT) Activation
Tidsramme: Up to 12 months after implementation
|
Number of Rapid Response Team (RRT) activation
|
Up to 12 months after implementation
|
|
Unplanned Transfers to Higher Level of Care
Tidsramme: Up to 12 months after implementation
|
Number of unplanned transfers to a higher level of care (intensive care unit or postoperative care unit)
|
Up to 12 months after implementation
|
|
Hospital Length of Stay
Tidsramme: Up to 12 months after implementation
|
Total hospital length of stay (hours)
|
Up to 12 months after implementation
|
|
NEWS-2 at Time of Clinical Deterioration
Tidsramme: Up to 12 months after implementation
|
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.
|
Up to 12 months after implementation
|
|
Pleasure of Work and Turnover Intention
Tidsramme: Baseline, 5 months, and 12 months after implementation
|
Healthcare professionals' perceived pleasure of work and turnover intention measured using validated composite measures.
Pleasure of work is assessed on a 4-point Likert scale (1-4) and turnover intention on a 5-point Likert scale (1-5).
Higher scores indicate greater pleasure of work and lower turnover intention.
|
Baseline, 5 months, and 12 months after implementation
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gørill H. Birkeli, PhD, University Hospital, Akershus
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Implementering
- Teleovervågning
- Patientsikkerhed
- kvalitativ undersøgelse
- Bærbare enheder
- Digital sundhed
- Sygeplejersker
- Patientovervågning
- Postoperative patienter
- Sundhedspersonale
- Fokusgruppeinterview
- Patient forværring
- Kvasi-eksperimentelt design
- Patientsikkerhedskultur
- Continuous vital sign monitoring
- Early warning scores
- National Early Warning Score (NEWS-2)
- Hospital Survey on Patient Safety Culture (HSOPSC 2.0)
- Employee motivation
- Work-related outcomes
- Technology implementation
- SEIPS
- Gastro-surgical ward
Andre undersøgelses-id-numre
- CVSM-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Patientsikkerhed
-
Columbia AsiaAfsluttetPatient Compliance | Læge-patient forholdIndien
-
University of AarhusUkendtPatientengagement | Patient Empowerment | Patient Compliance
-
Peking Union Medical College HospitalAfsluttetPatient efter hjerteklapkirurgi | Patient med langvarig mekanisk ventilationKina
-
University of British ColumbiaAfsluttetMeddelelse | Tilfredshed | Læge-patient forhold | Sygeplejerske-patient relationerCanada
-
University of California, San DiegoPatient-Centered Outcomes Research Institute; University of Massachusetts... og andre samarbejdspartnereAfsluttetPatientengagement | Læge-patient forhold | Lægens rolle | Patient aktiveringForenede Stater
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science UniversityAfsluttet
-
University of Dublin, Trinity CollegeDublin Dental University HospitalRekrutteringOverholdelse, patientIrland
-
Centre Hospitalier le MansAfsluttet
-
Fondazione Policlinico Universitario Agostino Gemelli...AfsluttetHjertekirurgisk patientItalien
-
Gustave Roussy, Cancer Campus, Grand ParisAfsluttet
Kliniske forsøg med Continuous Vital Sign Monitoring (CVSM)
-
Hamilton Health Sciences CorporationMcMaster University; Population Health Research Institute; Cloud DX Inc.Ikke rekrutterer endnu
-
Hamilton Health Sciences CorporationMcMaster University; Population Health Research Institute; Cloud DX Inc.AfsluttetBlodtryk | Respiration | Temperatur | Hjerterytme | Iltmætning | PulsfrekvensCanada
-
Sunnybrook Health Sciences CentreCanadian Consortium on Neurodegeneration in AgingRekrutteringDemens | Alzheimers sygdom | Søvnapnø | Mild kognitiv svækkelseCanada
-
University of Alabama at BirminghamNorthwestern University; University of Chicago; National Institutes of Health... og andre samarbejdspartnereIkke rekrutterer endnuTrauma | Pædiatrisk ALT | Appendektomi | Overvågning af vitale tegn
-
Ann & Robert H Lurie Children's Hospital of ChicagoRekrutteringPræmaturitetForenede Stater
-
Sunnybrook Health Sciences CentreAlzheimer Society of CanadaRekruttering
-
Abbott Diabetes CareLiverpool University Hospitals NHS Foundation Trust; NHS Lothian; Cardiff... og andre samarbejdspartnereAfsluttetDiabetes mellitusDet Forenede Kongerige
-
Barnev LtdAfsluttetArbejdskraft | ObstetrikIsrael
-
University Hospital, Basel, SwitzerlandClinical Trial Unit, University Hospital Basel, SwitzerlandAfsluttet