Clinical trial NCT04344665: Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial
Official title: Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Perioperative Complication
COVID
Keywords: Virtual care
Remote monitoring
Days alive at home
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: McMaster University
First posted: 2020-04-14
Enrollment: 905
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) 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 days alive at home during the 30-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. It will also determine, during the first 30 days, the effect of virtual care with RAM technology on several secondary outcomes, including: 1. hospital re-admission; 2. emergency department visit; 3. urgent-care centre visit; 4. acute-hospital care (i.e., a composite of hospital re-admission and emergency department or urgent-care centre visit) 5. brief acute-hospital care (i.e., acute-hospital care that lasts \<24 hours); 6. all-cause hospital days; 7. medication error detection; 8. medication error correction; and 9. death. An additional secondary objective is to determine the effect of virtual care with RAM technology on pain at 7, 15, and 30 days and 6 months after randomization.


Eligibility criteria: Inclusion Criteria:

1. are ≥40 years of age;
2. have undergone same-day or inpatient semi-urgent, urgent, or emergency surgery and are being discharged home or are within 24 hours after discharge home, as long as they have not had acute-hospital care since their discharge; and
3. provide informed consent to participate.

Exclusion Criteria:

1. underwent same-day surgery and the surgeon or anesthesiologist believe the case reflects a traditional same-day surgery case with a low likelihood of needing acute-hospital care;
2. went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;
3. are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a cognitive, language, visual, or hearing impairment; or
4. reside in an area without cellular network coverage and no home Wi-Fi.

Primary outcomes:
measure: Days alive at home
timeFrame: 30 Days (after randomization); 6 months (after randomization)
Secondary outcomes:
measure: Hospital re-admission
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Emergency Department visit
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Urgent Care centre visit
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Brief acute hospital care
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Medication error detection
timeFrame: Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
measure: Medication error correction
timeFrame: Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
measure: Death
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Participant Pain
timeFrame: 7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization)
measure: Acute hospital care
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: All-cause hospital days
timeFrame: 30 Days (after randomization); 6 months (after randomization)
Other outcomes:
measure: Health services utilization-related costs
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Patient level cost of recovery
timeFrame: 30 Days (after randomization)
measure: Re-operation
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Arrythmia resulting in electrical cardioversion
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Acute renal failure resulting in dialysis
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Respiratory failure
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Infection
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Surgical site infection
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Life-threatening bleed
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Major bleed
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Critical organ bleed
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Ileus
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Myocardial Infarction
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Clinically important atrial fibrillation
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Symptomatic proximal venous thrombo-embolism
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Stroke
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Non-fatal cardiac arrest
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Clostridium difficile-associated diarrhea
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Indwelling device
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: COVID-19 Infection
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Delirium
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Surgeon, family physician, or specialist in-person clinic visit
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Sepsis
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Acute Heart Failure
timeFrame: 30 Days (after randomization); 6 months (after randomization)
measure: Surgeon, family physician, or specialist virtual visit
timeFrame: 30 Days (after randomization); 6 months (after randomization)
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
city: Hamilton
country: Canada
facility: Juravinski Hospital
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
city: London
country: Canada
facility: London Health Sciences Centre
Study officials:
affiliation: McMaster University, Population Health Research Institute
name: Michael McGillion, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University, Population Health Research Institute
name: PJ Devereaux, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Ouellette C, Bird M, Ofori S, Roshanov PS, Patel A, Yang H, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Conen D, Harvey V, Lounsbury J, Mian R, Bangdiwala SI, Arellano R, Scott T, Guyatt GH, Gao P, Graham M, Nenshi R, Forster AJ, Nagappa M, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Harlock J, Meyer RM, Taylor DA, Shanthanna H, Schlachta CM, Parry N, Pichora DR, Yousuf H, Peter E, Lamy A, Petch J, Moloo H, Sehmbi H, Waggott M, Shelley J, Belley-Cote EP, Devereaux PJ; PVC-RAM-1 Investigators. Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial. BMJ. 2021 Sep 30;374:n2209. doi: 10.1136/bmj.n2209.
citation: McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Yang H, Patel A, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Ouellette C, Bird M, Ofori S, Conen D, Roshanov PS, Harvey V, Guyatt GH, Le Manach Y, Bangdiwala SI, Arellano R, Scott T, Lounsbury J, Taylor DA, Nenshi R, Forster AJ, Nagappa M, Lamy A, Peter E, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, Paul J, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Schlachta CM, Shelley J, Harlock J, Meyer RM, Graham M, Shanthanna H, Parry N, Pichora DR, Yousef H, Moloo H, Sehmbi H, Waggott M, Belley-Cote EP, Whitlock R, Devereaux PJ; PVC-RAM Investigators. Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial. CMAJ Open. 2021 Mar 2;9(1):E142-E148. doi: 10.9778/cmajo.20200176. Print 2021 Jan-Mar.