Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 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)-3 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 length of index hospital stay after randomization, in adults who have undergone elective non cardiac surgery. Secondary outcomes at 30 days after randomization include 1) acute hospital care (composite of hospital readmission and emergency department visit) 2) hospital re-admission; 3) emergency department visit; 4) medication error detection; 5) medication error correction; 6) surgical site infection; and 7) days in hospital. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 30 days after randomization. The investigators will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease and current smokers 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-3 (PVC-RAM-3) Trial

Conditions
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Surgery

Intervention / Treatment
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* Device: Virtual care with remote automated monitoring (RAM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are ≥18 years of age; are undergoing inpatient elective noncardiac surgery with an expected length of hospital stay ≤3 days after surgery; and provide informed consent to participate. Exclusion Criteria: are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a language barrier or a cognitive, visual, or hearing impairment; or reside in an area without cellular network coverage.

Ages Eligible for Study
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Minimum Age: 18 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: Other
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-3 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 wound photos during the 14 days after discharge. 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. | Device: Virtual care with remote automated monitoring (RAM)<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 per treating institution. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index hospital length of stay | Length of stay from randomization until discharge from the index hospitalization (measured in days and hours) | 30 Days post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute hospital care (composite of hospital readmission and emergency department visit) | Acute-hospital care is a composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit. | 30 Days post randomization | 
| Hospital readmission | Patient admission to an acute-care hospital. | 30 days post randomization | 
| Emergency department visit (includes urgent care centre visit) | Patient visit to an emergency department, which includes urgent-care centre visit. | 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. | 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 | 
| Days in hospital | Days in hospital | 30 days post randomization | 
| Level of pain and pain related interference in recovery | Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).4 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). The BPI-SF interference subscale will also be used, which measures the degree to which pain interferes with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life (NRS for each item; 0=does not interfere, 10=completely interferes). A total interference score is determined by calculating the sum of these 7 items. The BPI-SF has strong psychometric properties with well-established reliability and validity across divergent surgical groups. Moderate to severe pain is defined by a score of ≥4/10 on a standard numeric rating scale (NRS) for pain. | 15 and 30 days post randomization | 
| Optimization of medications for long-term health | 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). Among active smokers before surgery we will assess if patients are receiving pharmacological smoking cessation interventions at 30 days after randomization. | 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