Clinical trial NCT03253549: The SMArTVIEW, CoVeRed
Official title: TecHnology Enabled Self-MAnagemenT - VIsion for Remote Automated Patient Monitoring and EmpoWerment Following Cardiac and VasculaR Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery (Cardiac)
Surgery (Major Vascular)
Keywords: remote automated monitoring
hospital to home virtual care
cardiac surgery
major vascular surgery
self-management
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
name: Canadian Institutes of Health Research (CIHR)
name: Ontario Centres of Excellence
First posted: 2017-08-18
Enrollment: 572
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to SMArTVIEW or Standard Care.
Primary purpose: PREVENTION

Brief summary: The SMArTVIEW program evaluates the use of remote, automated monitoring in hospital and at home, on patients undergoing cardiac and major vascular surgery, to determine the effect on the 45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission). Half of participants will receive the SMArTVIEW intervention of increased monitoring, while the other half will receive standard care after surgery.

Detailed description: SMArTVIEW is an eHealth-enabled service delivery program that combines remote automated monitoring, education, and self-management training. SMArTVIEW is a two-stage intervention program. Stage 1 supports seniors after cardiac or major vascular surgery in hospital on the surgical unit (post-ICU). Participants are assigned automated, cableless, vital sign monitoring devices that are worn during their entire stay on the surgical unit (blood pressure cuff, respiration pod, and oxygen saturation probe). Any signs of deterioration are sent via handheld device to the primary care nurse for early intervention.

With a view to seamless transition home, Stage 2 supports these individuals at home during the first 30 days of recovery. Participants are sent home with Bluetooth enabled monitoring equipment including a tablet, blood pressure cuff, thermometer, pulse oximeter and weight scale. From home, the tablet uploads patients' vital signs and measurements automatically and sends them, via secure cloud infrastructure, to the SMArTVIEW Nurse on the surgical ward back at the hospital. The tablet interface also prompts patients to respond to brief, easy to read, daily surveys in order to inform the nurse about their status. The tablet also supports secure daily video visits and daily interaction with the nurse for postoperative assessment and support, surgical wound photographs, as well as patient access to customized educational materials.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 60 years;
2. Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the surgical floor;
3. Anticipated length of stay (LOS) on the surgical floor is ≥ 48 hours;
4. Patient has a negative Confusion Assessment Method (CAM) test result preceding, or within 12 hours of arriving on the surgical floor and is randomized within the first 24 hours after arriving on the ward;
5. Patient is able to provide consent autonomously.

Exclusion Criteria:

1. Patient is unable to communicate with research staff, complete surveys and questionnaires, or a telephone interview;
2. Patient has an intolerance/allergy to adhesive;
3. Patient unable to complete 30 days of at-home follow up due to current or planned relocation to nursing home or rehab facility; and
4. Patients with radial graft sites

Primary outcomes:
measure: Hospital Readmission Rate
timeFrame: Readmission within 45 days post discharge.
Secondary outcomes:
measure: Composite of Major Complications associated with Undetected Hemodynamic Compromise
timeFrame: 45 day and 6 months post discharge
measure: User Experience while on the SMArTVIEW Intervention compared to standard of care
timeFrame: 45 days and 6 months post discharge.
measure: Econometrics
timeFrame: 45 days and 6 months post discharge.
measure: Process & Implementation
timeFrame: Through study completion. An average of 1 year.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Liverpool
country: United Kingdom
facility: Liverpool Heart & Chest Hospital
state: England
Study officials:
References: