Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 15, 2025
Date Accepted: Apr 17, 2025
Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology 3 (PVC-RAM-3) trial: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
A substantial proportion of patients require acute hospital care after hospital discharge post-surgery, and many regions and countries have surgical backlogs.
Objective:
The post-discharge after surgery Virtual Care with Remote Automated Monitoring technology-3 (PVC-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VCRAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that post-discharge VCRAM will reduce acute hospital care.
Methods:
The PVC-RAM-3 trial is a randomized controlled trial that compares VCRAM to standard post-discharge care among 2500 adults undergoing elective non-cardiac surgery in three Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VCRAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada approved cellular modem-enabled tablet computer and Bluetooth-enabled RAM technology from Cloud Dx to take daily wound photos for 7 days, and measure daily vital signs (i.e., blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post-discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a pre-assigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive post discharge care as per the standard of care at the hospital where they undergo surgery. The co-primary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization.
Results:
Study recruitment and follow up is completed and analysis of the study results is underway.
Conclusions:
This trial will offer insights into the role of VCRAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. Clinical Trial: ClinicalTrials.gov, no. NCT05171569
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