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Recruiting NCT04876950

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

Trial Parameters

Condition Surgery
Sponsor Population Health Research Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 2,000
Sex ALL
Min Age 40 Years
Max Age N/A
Start Date 2024-10-04
Completion 2025-12
Interventions
Virtual care with remote automated monitoring

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.

Eligibility Criteria

Inclusion Criteria: 1. are ≥40 years of age; 2. will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and 3. provide informed consent to participate. Exclusion Criteria: 1. planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery; 2. 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 3. reside in an area without cellular network coverage.

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