Vitaliti Continuous Vital Signs Monitor User-Testing Protocol: VERDICT-2
- Conditions
- Surgery
- Interventions
- Other: User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A
- Registration Number
- NCT06464094
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
- Age >18 years
- Family or non-family member, residing in the same household as the patient or closely involved in the patient's postoperative recovery
- Provide written informed consent to participate in the VERDICT-2 Study
Family/Care Giver
- Caregivers with cognitive or physical impairments hindering understanding the scope of the device or ability to interact with the device or unable to communicate with research staff, complete study surveys, or undertake an interview using technology will not be eligible for recruitment
Clinician Inclusion Criteria:
- Registered Nurse or Physician engaged in perioperative care
- Employed at Hamilton Health Sciences
- Provide written informed consent to participate in the VERDICT-2 Study
Clinician Exclusion Criteria:
- Clinicians unable to understand the scope of the device or ability to interact with the device or unable to communicate with research staff, complete study surveys, or undertake an interview using technology due to language barriers will not be eligible for recruitment
- Non-practicing class of licensure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A Participants enrolled to engage in user-testing of the Vitaliti Continuous Vital Sign Monitor Model CVSM-1A 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.
- Primary Outcome Measures
Name Time Method Task analysis During user testing (Single sitting; 30-60 Minute duration) 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.
Impressions of usability (Caregivers) 72 hour (single sitting; 30-60 Minute interview) 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.
Wearability (Patients) 72 hours 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.
Impressions of usability (Patients) 72 hours (single sitting; 30-60 Minute interview) 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.
Impressions of usability (Clinicians) During user testing (single sitting; 30-60 Minute interview) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
McMaster University
🇨🇦Hamilton, Ontario, Canada