Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial

Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.

Total number of days in hospital from randomization to 45 days post-randomization, including index hospital stay and any hospital readmission (s). A day in hospital is counted if a participant spends 1 minute of any day admitted to hospital.

Length of hospital stay calculated from time of surgery completion (i.e., time of surgical wound closure) until discharge from the index hospitalization (measured in days and hours).

Patient admission to an acute-care hospital.

Patient visit to an emergency department.

Medication errors include mistakes in medication prescribing, transcribing, dispensing, administering, or monitoring due to preventable events or actions taken by a patient, caregiver, or healthcare worker. Medication errors include: drug omission (i.e., patient did not take a drug they were supposed to take), drug commission (i.e., patient taking a drug they were not supposed to take), duration error, dosing error, frequency error, route error, and timing error. We will record all drug errors identified and also report whether they resulted in harm.

Any medication error that is corrected.

Surgical site infection is an infection that occurs within 30 days after randomization and involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional).

Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).The BPI-SF includes four 11-point numeric rating scales (NRS) of pain intensity, which measure "average", "least", and "worst" pain intensity in the past 24 hours (hrs.), respectively, as well as pain intensity "now" (0= no pain, 10= pain as bad as you can imagine).

Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).The BPI-SF includes four 11-point numeric rating scales (NRS) of pain intensity, which measure "average", "least", and "worst" pain intensity in the past 24 hours (hrs.), respectively, as well as pain intensity "now" (0= no pain, 10= pain as bad as you can imagine). Pain is of moderate or greater severity is defined by a score of ≥4/10 on a standard numeric rating scale (NRS) for pain.

Among patients with atherosclerotic disease, we will also assess optimal pharmacological management based upon whether patients are taking 0, 1, 2, or 3 of the following classes of efficacious medications at 45 days (i.e., an antiplatelet or anticoagulant drug; an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker; and a statin).

Among patient who self-report to be current smokers at baseline, we will assess if patients are receiving pharmacological smoking cessation interventions at 45 days after randomization.

Infection is defined as a pathologic process caused by the invasion of normally sterile tissue, fluid, or body cavity by pathogenic or potentially pathogenic organisms.

Re-operation refers to any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection).

4th Universal definition of myocardial infarction.

The definition of acute heart failure requires at least one of the following clinical signs (i.e., elevated jugular venous pressure, respiratory rales or crackles, crepitations, or presence of S3) with at least one of the following:

• radiographic findings of vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema, OR
• heart failure treatment with a diuretic and documented clinical improvement.

Any arrhythmia that results in patient presenting to an emergency department, which includes an urgent care centre, or being admitted to hospital.

All cause mortality.

HRQL will be measured with the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument (https://euroqol.org/eq-5d-instruments/sample-demo) due to its increased sensitivity and validation in several countries including Canada. The EQ-5D-5L is also recommended in Canada to calculate the Quality Adjusted Life Years (QALYs) when conducting cost-effectiveness analyses.

The EQ-5D-5L questionnaire consists of descriptive questions regarding 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with a 5-level scale for participants to indicate the most accurate response (ranging from no problems to extreme problems).

Costs associated with hospital re-admission, length of stay, and healthcare utilization will be obtained from administrative datasets.