Acute Medical Conditions, Postoperative Complications, User Experience
Conditions
Keywords
continuous wireless vital sign monitoring, vital sign deviation, healthcare system and culture, User Experience, Postoperative Complications, Acute Medical Conditions
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Rigshospitalet, Denmark
Christian S. Meyhoff
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patients experiences from being monitored with wCSVM. | during monitoring period, on average 3 months | 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. |
| Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day | during monitoring period, on average 3 months | — |
| Frequency of delivered alarms on respiration rate (RR) pr patient pr day | during monitoring period, on average 3 months | — |
| Frequency of delivered alarms on heart rate (HR) pr patient pr day | during monitoring period, on average 3 months | — |
| Frequency of delivered alarms on blod pressure (BP) pr patient pr day | during monitoring period, on average 3 months | — |
| Overall score of user satisfaction from use of WARD24/7 app | during monitoring period, on average 3 months | 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. |
| Subscale MAUQ scores | during monitoring period, on average 3 months | 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). |
| Monitoring practices prior to the wCVSM | Baseline, on average 3 months | 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.). |
| Response to alerts | during monitoring period, on average 3 months | will be assessed using the response buttons as % of nurses pressing attend, snooze, or refer to colleague on the WARD24/7 App. |
| Alert relay to smartphones | during monitoring period, on average 3 months | will be assessed by comparing % of alerts received compared to alerts generated by the WARD24/7 App. |
| Technical feasibility | during monitoring period, on average 3 months | 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. |
| Relevance of alarms | during monitoring period, on average 3 months | by using feedback from the nurses given in the app, % of relevant alerts |
Other
| Measure | Time frame |
|---|---|
| Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1 | during monitoring period, on average 3 months |
| Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o | during monitoring period, on average 3 months |
| Cumulative duration of Circulatory failure | during monitoring period, on average 3 months |
| 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 |
| Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88% | during monitoring period, on average 3 months |
| Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1 | during monitoring period, on average 3 months |
| Cumulative duration of SpO2<88% and SpO2 < 85% | during monitoring period, on average 3 months |
Countries
Germany, Netherlands, Norway, United Kingdom, United States
Contacts
Primary ContactKatja K Head of Clinical, MD
Backup ContactEske Kvanner Aasvang, MD
Outcome results
None listed