Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorPopulation Health Research Institute
About this trial
The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology-2 (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 45-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 45 days after randomization include 1) days in hospital; 2) index length of hospital stay; 3) hospital re-admission; 4) emergency department visit; 5) medication error detection; 6) medication error correction; and 7) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 45 days. We will also assess optimal management of long-term health by evaluating among self-reported current smokers and those with atherosclerotic disease, whether patients are taking classes of efficacious medications at 45 days post randomization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
are ≥40 years of age;
will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and
provide informed consent to participate.
Disqualifiers
planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery;
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual care with remote automated monitoring
Combination productUse of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Virtual Care with Remote Automated MonitoringExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Acute-hospital care
Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.
Time frame
45 days post randomizationSecondary outcomes
1
Days in hospital
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.
Time frame
45 days post randomization2
Index length of hospital stay
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).
Time frame
45 days post randomization3
Hospital readmission
Patient admission to an acute-care hospital.
Time frame
45 days post randomization4
Emergency department visit
Patient visit to an emergency department.
Time frame
45 days post randomizationOther outcomes
1
Infection
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
45 days post randomization2
Re-operation
Re-operation refers to any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection).
Time frame
45 days post randomization3
Myocardial Infarction
4th Universal definition of myocardial infarction.
Time frame
45 days post randomization4
Acute Heart Failure
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: 1. radiographic findings of vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema, OR 2. heart failure treatment with a diuretic and documented clinical improvement.
Time frame
45 days post randomizationSponsors and contacts
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Source ClinicalTrials.gov