Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,000
- Locations
- 2
- Primary Endpoint
- Acute-hospital care
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Acute-hospital care
Time Frame: 45 days post randomization
Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.
Secondary Outcomes
- Days in hospital(45 days post randomization)
- Index length of hospital stay(45 days post randomization)
- Hospital readmission(45 days post randomization)
- Medication error detection(45 days post randomization)
- Emergency department visit(45 days post randomization)
- Moderate to severe pain(15 and 45 days post randomization)
- Medication error correction(45 days post randomization)
- Optimal pharmacological management for patients with atherosclerotic disease(45 days post randomization)
- Optimal pharmacological management self-reported current smokers(45 days post randomization)
- Surgical site infection(45 days post randomization)
- Pain of any severity(15 and 45 days post randomization)