Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual care with remote automated monitoring.
- Who it may be relevant to
- Registry conditions: Surgery, Perioperative Complication. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Combination product Virtual care with remote automated monitoring
Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.
Primary outcome measures
- Acute-hospital care [Time frame: 45 days post randomization]
Secondary outcome measures (11)
- Days in hospital [Time frame: 45 days post randomization]
- Index length of hospital stay [Time frame: 45 days post randomization]
- Hospital readmission [Time frame: 45 days post randomization]
- Emergency department visit [Time frame: 45 days post randomization]
- Medication error detection [Time frame: 45 days post randomization]
- Medication error correction [Time frame: 45 days post randomization]
- Surgical site infection [Time frame: 45 days post randomization]
- Pain of any severity [Time frame: 15 and 45 days post randomization]
- Moderate to severe pain [Time frame: 15 and 45 days post randomization]
- Optimal pharmacological management for patients with atherosclerotic disease [Time frame: 45 days post randomization]
- Optimal pharmacological management self-reported current smokers [Time frame: 45 days post randomization]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Canada · 2 centers
- Hamilton General Hospital — Hamilton
- Juravinski Hospital — Hamilton
Identifiers
NCT: NCT04876950 · 1.0.2021.04.30