THE SMArTVIEW, CoVeRed (SMArTVIEW)

TecHnology Enabled Self-MAnagemenT - VIsion for Remote Automated Patient Monitoring and EmpoWerment Following Cardiac and VasculaR Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery (Cardiac); Surgery (Major Vascular)
• Intervention / Treatment: Device: SMArTVIEW

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.

• Study Type: Interventional
• Enrollment (Actual): 572
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
• United Kingdom
  • England
    • Liverpool, England, United Kingdom, L14 3PE
      • Liverpool Heart & Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care
Experimental: SMArTVIEW	Device: SMArTVIEW; Remote automated, continuous monitoring in hospital after cardiac or vascular surgery, followed by 30-day at home monitoring, daily nurse video visits and a self-management training program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Readmission Rate	45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission).	Readmission within 45 days post discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Major Complications associated with Undetected Hemodynamic Compromise	Composite death, non-fatal myocardial infarction, non-fatal stroke, non-fatal cardiac arrest, congestive heart failure, clinically important atrial fibrillation, deep vein thrombosis or pulmonary embolism, bleeding, respiratory failure, falls, delirium, reoperation, important hypotension, acute kidney injury w/ dialysis, infection/sepsis and medication error detection and correction.	45 day and 6 months post discharge
User Experience while on the SMArTVIEW Intervention compared to standard of care	Patient and clinician experience, family/caregiver experience, patient's functional status, patient activation, postoperative pain and satisfaction with care.	45 days and 6 months post discharge.
Econometrics	Health service utilization-related costs and patient-level of cost of recovery.	45 days and 6 months post discharge.
Process & Implementation	Barriers and facilitators to the intervention	Through study completion. An average of 1 year.

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); Population Health Research Institute; Ontario Centres of Excellence

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): November 15, 2021
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; self-management; remote automated monitoring; hospital to home virtual care; major vascular surgery
• Other Study ID Numbers: SMArTVIEW v1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No