THE SMArTVIEW, CoVeRed

Surgery (Cardiac) Clinical Trial

— SMArTVIEW  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03253549
• Other study ID #: SMArTVIEW v1.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: August 15, 2024

Study information

• Verified date: January 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 572
• Est. completion date: August 15, 2024
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery (Cardiac)
• Surgery (Major Vascular)

Intervention

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.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
United Kingdom	Liverpool Heart & Chest Hospital	Liverpool	England

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), Ontario Centres of Excellence, Population Health Research Institute

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	Econometrics	Health service utilization-related costs and patient-level of cost of recovery.	45 days and 6 months post discharge.
Secondary	Process & Implementation	Barriers and facilitators to the intervention	Through study completion. An average of 1 year.