The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with post-surgical participants, their family members (caregiver support role) and clinicians (nurses and physicians) at Hamilton Health Sciences to examine user acceptance and user experiences, while soliciting user feedback on wearability compliance and proposed clinical workflows.
Effective postoperative care is faced with several challenges- patients experience major complications following surgery, which often require re-hospitalization or utilization of healthcare services (i.e., emergency room visits) once discharged into the community. New remote automated monitoring (RAM) technologies that enable data integration, synthesis, and real-time alerts to clinicians have the potential to transform postoperative care, similar to how intraoperative care has evolved. The Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) is a continuous vital sign monitor intended to measure vital metrics including systolic and diastolic blood pressures (via ECG/ photoplethysmography \[PPG\]), pulse (via PPG), respiration rate (via impedance respiration waveform), core body temperature (via infrared sensor), and blood oxygen saturation levels (via PPG) of an adult individual using non-invasive techniques. The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with post-surgical participants, their family members (caregiver support role) and clinicians (nurses and physicians) at Hamilton Health Sciences to examine user acceptance and user experiences, while soliciting user feedback on wearability compliance and proposed clinical workflows.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
45
Single group enrollment to examine user-acceptance and user experiences, while soliciting user feedback on wearability compliance (patient) and proposed clinical workflows using the most recent Vitaliti™ CVSM device.
McMaster University
Hamilton, Ontario, Canada
Task analysis
Assessment of all users' (patient, caregiver, clinician) performance of the required tasks during Vitaliti™ CVSM user testing according to the following designations: 'completed', 'completed with difficulty', or 'missed'. Descriptive data will be generated to summarize operational tasks that required the most support to complete.
Time frame: During user testing (Single sitting; 30-60 Minute duration)
Wearability (Patients)
Participant journal used to record any device removal occurrences reason why it was taken off, and for how long. Participants will also be asked to keep track of any experiential information they note while wearing the device, which will then be provided to the research team for review.
Time frame: 72 hours
Impressions of usability (Patients)
In-person post-test debrief interviews for patients, caregivers, and clinicians will be conducted using semi-structured interview methods following the task analysis user-testing exercise. These interviews will focus on perceptions of usability as they relate to root causes of sources of difficulty and particular events that may have occurred. Participants' overall impressions of the usability of the Vitaliti™ system will also be captured, focusing on perceived successes and failures, impressions of what may be done differently next time, as well as feedback on the in-service and training materials provided. Analysis by qualitative methods.
Time frame: 72 hours (single sitting; 30-60 Minute interview)
Impressions of usability (Caregivers)
In-person post-test debrief interviews for patients, caregivers, and clinicians will be conducted using semi-structured interview methods following the task analysis user-testing exercise. These interviews will focus on perceptions of usability as they relate to root causes of sources of difficulty and particular events that may have occurred. Participants' overall impressions of the usability of the Vitaliti™ system will also be captured, focusing on perceived successes and failures, impressions of what may be done differently next time, as well as feedback on the in-service and training materials provided. Analysis by qualitative methods.
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Time frame: 72 hour (single sitting; 30-60 Minute interview)
Impressions of usability (Clinicians)
In-person post-test debrief interviews for patients, caregivers, and clinicians will be conducted using semi-structured interview methods following the task analysis user-testing exercise. These interviews will focus on perceptions of usability as they relate to root causes of sources of difficulty and particular events that may have occurred. Participants' overall impressions of the usability of the Vitaliti™ system will also be captured, focusing on perceived successes and failures, impressions of what may be done differently next time, as well as feedback on the in-service and training materials provided. Analysis by qualitative methods.
Time frame: During user testing (single sitting; 30-60 Minute interview)