Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

Postoperative Complications Clinical Trial

Official title:

Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289699
• Other study ID #: WARD-CSS international 1251
• Status: Recruiting
• Start date: February 26, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Katja K Head of Clinical, MD
• Phone: 555-555-5555
• Email: katja.groenbaek[@]ward247.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (=18 years)
• Expected stay in the hospital =2 days
• Admitted for surgery with expected duration of surgery >2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff
• RR > 21 breaths pr minute
• RR < 11 breaths pr minute
• Pulse (P) > 91 beats pr minute
• Pulse (P) < 50 beats pr minute
• SpO2 < 94 % without oxygen supplementation
• Systolic BP < 110 mmHg
• Systolic BP > 220 mmHg

Exclusion Criteria:

• Participant expected not to cooperate with study procedures.
• Allergy to plaster or silicone.
• Pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
• Inability to give informed consent.

Related Conditions & MeSH terms

• Acute Medical Conditions
• Postoperative Complications
• User Experience

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie	Hamburg
Netherlands	University Medical Center Groningen, Department of Anesthesiology	Groningen
Norway	St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin	Trondheim
United Kingdom	Liverpool University Hospitals NHS Foundation Trust	Liverpool
United States	The Cleveland Clinic Foundation, General Anesthesiology	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Christian S. Meyhoff	Rigshospitalet, Denmark

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative duration of SpO2<88% and SpO2 < 85%		during monitoring period, on average 3 months
Other	Cumulative duration of respiratory rate = 5 min-1 and Respiratory rate > 24 min-1		during monitoring period, on average 3 months
Other	Cumulative duration of Heart rate > 130 min-1 and Heart rate = 30 min-1		during monitoring period, on average 3 months
Other	Cumulative duration of Systolic blood pressure = 90 mmHg and Systolic blood pressure > 220 mmHg o		during monitoring period, on average 3 months
Other	Cumulative duration of Circulatory failure		during monitoring period, on average 3 months
Other	Cumulative duration of Systolic blood pressure = 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o		during monitoring period, on average 3 months
Other	Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88%		during monitoring period, on average 3 months
Primary	Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data		during monitoring period, on average 3 months
Secondary	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.	during monitoring period, on average 3 months
Secondary	Alert relay to smartphones	will be assessed by comparing % of alerts received compared to alerts generated by the WARD24/7 App.	during monitoring period, on average 3 months
Secondary	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.	during monitoring period, on average 3 months
Secondary	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.	during monitoring period, on average 3 months
Secondary	Relevance of alarms	by using feedback from the nurses given in the app, % of relevant alerts	during monitoring period, on average 3 months
Secondary	Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day		during monitoring period, on average 3 months
Secondary	Frequency of delivered alarms on respiration rate (RR) pr patient pr day		during monitoring period, on average 3 months
Secondary	Frequency of delivered alarms on heart rate (HR) pr patient pr day		during monitoring period, on average 3 months
Secondary	Frequency of delivered alarms on blod pressure (BP) pr patient pr day		during monitoring period, on average 3 months
Secondary	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.	during monitoring period, on average 3 months
Secondary	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).	during monitoring period, on average 3 months
Secondary	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.).	Baseline, on average 3 months