Virtual care with remote automated monitoring (RAM)
DeviceUse of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.
NCT Number: NCT05171569
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 and use of acute hospital care (composite of hospital readmission and emergency department visit) after randomization, in adults who have undergone elective non cardiac 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; 5) surgical site infection; and 6) 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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hamilton General Hospital, Hamilton, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.
Time frame: 30 Days post randomization
Length of stay from randomization until discharge from the index hospitalization (measured in days and hours)
Time frame: 30 Days post randomization
Acute-hospital care is a composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.
Time frame: 30 days post randomization
Patient admission to an acute-care hospital.
Time frame: 30 days post randomization
Patient visit to an emergency department, which includes urgent-care centre visit.
Time frame: 30 days post randomization
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.
Time frame: 30 days post randomization
Any medication error that is corrected.
Time frame: 30 days post randomization
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).
Time frame: 30 days post randomization
Days in hospital
Time frame: 15 and 30 days post randomization
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.
Time frame: 30 days post randomization
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.
Time frame: 30 days post 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.
Time frame: 30 days post randomization
Re-operation refers to any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection).
Time frame: 30 days post randomization
The diagnosis of myocardial infarction requires criteria meeting 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:
Any arrhythmia that results in patient presenting to an emergency department, which includes an urgent care centre visit or being admitted to hospital.
Time frame: 30 days post randomization
All cause mortality
Time frame: 30 days post randomization
HRQoL will be measured with the EQ-5D-5L instrument (https://euroqol.org/eq-5d-instruments/sample-demo) due to its increased sensitivity and validation in several countries including Canada.4 The EQ-5D-5L is also recommended in Canada5 to calculate the Quality Adjusted Life Years (QALYs) when conducting cost-effectiveness analyses.
Time frame: 30 days post randomization
Data on hospital re-admission, length of stay, and healthcare utilization will be obtained from the Ontario Hospital Association Integrated Decision Support (IDS) database. IDS is a comprehensive platform with an integrated view of patient activity, allowing for access to health systems data for any patients enrolled. Data on costs of health service utilization will be obtained from the Ontario Case Costing Database.
Population Health Research Institute
Other
Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 (PVC-RAM-3) Trial
Acronym: PVC-RAM-3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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