The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.
The participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge. Monitoring devices used in this study will be validated FDA or/and CE approved devices used within their original purpose. Centers can choose to use Sotera Visimobile or Isansys Lifeguard with accompanying sensors. These devices will be used together with the CE approved WARD web and mobile application. Study sites include: St. Olav Hospital Trondheim, Royal Liverpool University Hospital, University Medical Centre Hamburg-Eppendorf,University Medical Centre Groningen, The Netherlands and the Cleveland Clinic.
Study Type
OBSERVATIONAL
Enrollment
100
The Cleveland Clinic Foundation, General Anesthesiology
Cleveland, Ohio, United States
NOT_YET_RECRUITINGUniversitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie
Hamburg, Germany
COMPLETEDUniversity Medical Center Groningen, Department of Anesthesiology
Groningen, Netherlands
RECRUITINGSt. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin
Trondheim, Norway
COMPLETEDLiverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
NOT_YET_RECRUITINGFrequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
Time frame: during monitoring period, on average 3 months
Technical feasibility
will be assessed as data capture of vital signs as percentage of data from each of the vital sign sensors of the total monitoring period.
Time frame: during monitoring period, on average 3 months
Alert relay to smartphones
will be assessed by comparing % of alerts received compared to alerts generated by the WARD24/7 App.
Time frame: during monitoring period, on average 3 months
Response to alerts
will be assessed using the response buttons as % of nurses pressing attend, snooze, or refer to colleague on the WARD24/7 App.
Time frame: during monitoring period, on average 3 months
Patients experiences from being monitored with wCSVM.
will be assessed by a questionnaire named "Patient experience with wireless vital sign monitorering" consisting of 8 items. Each item can be answered with: strongly agree, agree, neither agree nor disagree, disagree, and strongly disagree.
Time frame: during monitoring period, on average 3 months
Relevance of alarms
by using feedback from the nurses given in the app, % of relevant alerts
Time frame: during monitoring period, on average 3 months
Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day
Time frame: during monitoring period, on average 3 months
Frequency of delivered alarms on respiration rate (RR) pr patient pr day
Time frame: during monitoring period, on average 3 months
Frequency of delivered alarms on heart rate (HR) pr patient pr day
Time frame: during monitoring period, on average 3 months
Frequency of delivered alarms on blod pressure (BP) pr patient pr day
Time frame: during monitoring period, on average 3 months
Overall score of user satisfaction from use of WARD24/7 app
assessed by the mHealth App Usability Questionnaire (MAUQ) consisting of 18 items. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.
Time frame: during monitoring period, on average 3 months
Subscale MAUQ scores
assessed by the mHealth App Usability Questionnaire (MAUQ) consisting of 18 items. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app. Ease of use and satisfaction (5 items, MAUQ\_E), system information arrangement (7 items, MAUQ\_I), and usefulness (6 items, MAUQ\_U).
Time frame: during monitoring period, on average 3 months
Monitoring practices prior to the wCVSM
assessed by a semi structured interview guide including information on type of monitoring (manual/intermittent, type of vital signs collected, frequency of measurements, escalation protocols etc.).
Time frame: Baseline, on average 3 months
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