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

Study Overview
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Brief Summary
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The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM)-2 Trial is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of virtual care with remote automated monitoring (RAM) technology compared to standard care on acute-hospital care during the 30-day follow up after randomization, in adults who have undergone semi-urgent (e.g., oncology), urgent (e.g., hip fracture), or emergency (e.g., ruptured abdominal aortic aneurysm) surgery. Secondary outcomes at 30 days after randomization include 1) hospital re-admission; 2) emergency department visit; 3) medication error detection; 4) medication error correction; and 5) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 7, 15, and 30 days. We will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease whether patients are taking classes of efficacious medications at 30 days.

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

Conditions
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Surgery, Perioperative Complication

Intervention / Treatment
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* Combination Product: Virtual care with remote automated monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are ≥40 years of age; have undergone inpatient semi-urgent, urgent, or emergency surgery and the most responsible physician has decided to discharge the patient; are on the day of being discharged home or are within 24 hours after discharge home without having obtained acute hospital care since discharge; and provide informed consent to participate. Exclusion Criteria: went to rehabilitation or convalescent care for more than 7 days after undergoing surgery; are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to cognitive, visual, or hearing impairment; or reside in an area without cellular network coverage.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Care with Remote Automated Monitoring<br>Patients randomized to the PVC-RAM-2 intervention will take biophysical measurements with the RAM technology, complete a daily recovery survey, complete video visits with a virtual care clinical team, and take would photos during the 30 days after randomization. If the patient's RAM measurements exceed predetermined thresholds, the patient reports specific symptoms (e.g., shortness of breath), a drug error is identified, or the virtual nurse has concerns about the patient's health that they cannot resolve, the virtual nurse will escalate care to a pre-assigned and available physician. | Combination Product: Virtual care with remote automated monitoring<br>* Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.<br>|
| No Intervention: Standard Care<br>Standard post-surgical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute-hospital care | Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit. | 30 days post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission | Patient admission to an acute-care hospital. | 30 days post randomization | 
| Emergency department visit | Patient visit to an emergency department. | 30 days post randomization | 
| Medication error detection | 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. | 30 days post randomization | 
| Medication error correction | Any medication error that is corrected. | 30 days post randomization | 
| Surgical site infection | 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). | 30 days post randomization | 
| Pain of any severity | Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).19 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). | 7, 15, and 30 days post randomization | 
| Moderate to severe pain | Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).19 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. | 7, 15, and 30 days post randomization | 
| Optimal pharmacological management for patients with atherosclerotic disease | 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 30 days (i.e., an antiplatelet or anticoagulant drug; an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker; and a statin). | 30 days post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual care, Remote monitoring, Acute hospital care