Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial.
Journal
CMAJ open
ISSN: 2291-0026
Titre abrégé: CMAJ Open
Pays: Canada
ID NLM: 101620603
Informations de publication
Date de publication:
Historique:
entrez:
3
3
2021
pubmed:
4
3
2021
medline:
11
3
2021
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov, no. NCT04344665.
Sections du résumé
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.
Identifiants
pubmed: 33653769
pii: 9/1/E142
doi: 10.9778/cmajo.20200176
pmc: PMC8034369
doi:
Banques de données
ClinicalTrials.gov
['NCT04344665']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
E142-E148Investigateurs
Darrin Payne
(D)
Rachael DaCunha
(R)
Sunil Patel
(S)
Michael Yacob
(M)
Siddhartha Srivastava
(S)
Lisa Nguyen
(L)
Curtis Nickel
(C)
Tyler Hands
(T)
Elorm Vowotor
(E)
Emile Peponoulas
(E)
Angela Webster
(A)
Tammy Doyle
(T)
Kajenny Srivaratharajah
(K)
Dave Szalay
(D)
Deborah Bedini
(D)
Victor Chu
(V)
Jason Busse
(J)
Sandra Carroll
(S)
Jeremy Petch
(J)
Duane Bender
(D)
Dina Brooks
(D)
Krysten Gregus
(K)
Patricia Power
(P)
Dale Williams
(D)
Amitabha Chakroborty
(A)
Samir Raza
(S)
Amna Ahmed
(A)
Kelly Lawrence
(K)
Derek Hunt
(D)
David Cowan
(D)
Jehonathan Pinthus
(J)
David Wilson
(D)
Clare Reade
(C)
Leslie Gauthier
(L)
Stephen Kelly
(S)
Kirsten Krull
(K)
Kim Alvarado
(K)
Susan Reid
(S)
Mohit Bhandari
(M)
Derek Dillane
(D)
James Greene
(J)
David Bigam
(D)
Ryan Snelgrove
(R)
Brian Buchanan
(B)
Oleksa Rewa
(O)
Ronald Brisebois
(R)
Nadr Jomha
(N)
Bruce Ritchie
(B)
Sherry Reid
(S)
Adrian Fairey
(A)
Greg Hrynchyshyn
(G)
Bobby Shayegan
(B)
Christian Finley
(C)
Wendy Lim
(W)
Maria Tiboni
(M)
David Choi
(D)
Anne-Marie MacDonald
(AM)
Deanna Burnette
(D)
Tom Stewart
(T)
Melissa Farrell
(M)
Carolyn Goss
(C)
Faraaz Quiraishi
(F)
Daniel McIsaac
(D)
Sarah Tierney
(S)
Shawn Hicks
(S)
Kathryn Wheeler
(K)
Josh Robert
(J)
Colleen McFaul
(C)
Greg Krolczyk
(G)
Purnima Rao
(P)
Stephane Moffett
(S)
Dan Dubois
(D)
Catherine Code
(C)
Heather Clark
(H)
Melissa Rousseau
(M)
Catherine Gray
(C)
Dominique Yelle
(D)
Youssef Tawil
(Y)
Babak Rashidi
(B)
Weiwei Beckerleg
(W)
Shipa Gupta
(S)
Sudhir Sundaresan
(S)
Suzanne Madore
(S)
Andrew Seely
(A)
Reece Bearnes
(R)
Dean Fergusson
(D)
Susan Madden
(S)
Jad Abou Khalil
(J)
John Sinclair
(J)
Moein Momtazi
(M)
Rodney Breau
(R)
Humberto Vigil
(H)
James Chan
(J)
Freddy Nguyen
(F)
George Nicolaou
(G)
Yamini Subramani
(Y)
Ashraf Fayad
(A)
Amit Garg
(A)
Cathy Vandersluis
(C)
Glen Kearns
(G)
Cheryl Churcher
(C)
Carla Cormack
(C)
Brenda Maxwell
(B)
Johana Halabi
(J)
James Calvin
(J)
Douglas Naudie
(D)
Melfort Boulton
(M)
Stephanie Handsor
(S)
Heather Whittle
(H)
Charlotte Kenning
(C)
Lori Blake
(L)
Sanela Dragic-Taylor
(S)
Arielle Fernandez
(A)
Peggy Gao
(P)
Valerie Harvey
(V)
Peter Koh
(P)
Louise Mastrangelo
(L)
John Liu
(J)
Yan Yun Liu
(YY)
Rajibul Mian
(R)
Wesley Tong
(W)
Jessica Vincent
(J)
Heidi Wilton
(H)
Flavia K. Borges
(FK)
Sandra Ofori
(S)
Michael Wang
(M)
James Khan
(J)
Rahima Nenshi
(R)
Maura Marcucci
(M)
Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2021 Joule Inc. or its licensors.
Déclaration de conflit d'intérêts
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.
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