Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial

Abstract

Background: After nonelective (i.e., semiurgent, urgent and emergent) surgeries, patients discharged from hospitals are at risk of readmissions, emergency department visits or death. During the coronavirus disease 2019 (COVID-19) pandemic, we are undertaking the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) trial to determine if virtual care with remote automated monitoring (RAM) compared with standard care will increase the number of days adult patients remain alive at home after being discharged following nonelective surgery.

Methods: We are conducting a randomized controlled trial in which 900 adults who are being discharged after nonelective surgery from 8 Canadian hospitals are randomly assigned to receive virtual care with RAM or standard care. Outcome adjudicators are masked to group allocations. Patients in the experimental group learn how to use the study's tablet computer and RAM technology, which will measure their vital signs. For 30 days, patients take daily biophysical measurements and complete a recovery survey. Patients interact with nurses via the cellular modem-enabled tablet, who escalate care to preassigned and available physicians if RAM measurements exceed predetermined thresholds, patients report symptoms, a medication error is identified or the nurses have concerns they cannot resolve. The primary outcome is number of days alive at home during the 30 days after randomization.

Interpretation: This trial will inform management of patients after discharge following surgery in the COVID-19 pandemic and offer insights for management of patients who undergo nonelective surgery in a nonpandemic setting. Knowledge dissemination will be supported through an online multimedia resource centre, policy briefs, presentations, peer-reviewed journal publications and media engagement.

Trial registration: ClinicalTrials.gov, no. NCT04344665.

Conflict of interest statement

Competing interests: CloudDX undertook training sessions for study nurses, perioperative physicians and surgeons regarding how to use their technology. David Conen has received personal fees from Servier Canada, outside of the current work. Emil Schemitsch has received personal fees from Stryker, Smith & Nephew, ITS Implants, Acumed, Swemac and DePuy Synthes, outside the present work. Emilie Belley-Cote has received grants from Bayer and Roche, outside the present work. Richard Whitlock has received grants from Bayer, Roche and Boehringer Ingelheim, an honorarium from Boehringer Ingeheim and consulting fees from AtriCure and PhaseBio, outside the present work. P.J. Devereaux has received a grant from Roche Diagnostics for the present work and grants from Abbott Diagnostics, Boehringer Ingeheim, Roche Diagnostics and Siemens, outside the present work, as well as patient monitors from Philips Healthcare and troponin assays from Siemens, outside the present work.

© 2021 Joule Inc. or its licensors.

Figures

Figure 1:

Trial flow chart.

Figure 2:

Cloud DX Connected Health Kit, including Bluetooth-enabled Pulsewave wrist cuff blood pressure monitor, body weight scale, wireless oximeter and temperature probe, paired with Android health tablet. Reproduced with permission from Cloud DX.