Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial (PVC-RAM)

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.

Study Overview

• Status: Completed
• Conditions: Surgery; COVID; Perioperative Complication
• Intervention / Treatment: Other: Virtual Care and Remote Automated Monitoring

• Study Type: Interventional
• Enrollment (Actual): 905
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Hamilton, Canada
    • Hamilton General Hospital
  • Hamilton, Canada
    • Juravinski Hospital
  • Hamilton, Canada
    • St. Joseph's Healthcare Hamilton
  • Kingston, Canada
    • Kingston Health Sciences Centre
  • London, Canada
    • London Health Sciences Centre
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care
Experimental: Virtual Care and Remote Automated Monitoring	Other: Virtual Care and Remote Automated Monitoring; Patients will measure daily vitals (blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, weight) with remote monitoring technology and complete recovery surveys daily in home after discharge from hospital. Patients will interact with a virtual nurse daily on days 1-15 and every other day from days 16-30. If the patient's RAM measurements exceed predetermined thresholds, the patient reports specific symptoms (e.g., shortness of breath), a drug error is identified, or the virtual nurse has concerns about the patient's health that they cannot resolve, the virtual nurse will escalate care to a pre-assigned and available physician. Physicians will add or modify treatments as needed, and if required, they will have the patient come to an outpatient facility for evaluation or management. Via secure video or text messaging, patients will also have access to a virtual nurse at night, for any urgent issues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days alive at home	Days alive at home are the number of days patients spend at their usual residence - be it a house or apartment, a group home or shelter, a seniors residence, or a nursing home - or at a community residence of a relative, friend, or acquaintance without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Thus, patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.	30 Days (after randomization); 6 months (after randomization)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital re-admission		30 Days (after randomization); 6 months (after randomization)
Emergency Department visit		30 Days (after randomization); 6 months (after randomization)
Urgent Care centre visit		30 Days (after randomization); 6 months (after randomization)
Brief acute hospital care		30 Days (after randomization); 6 months (after randomization)
Medication error detection	Medication errors include mistakes in medication prescribing, transcribing, dispensing, administering, or monitoring due to preventable events or actions taken by a patient, caregiver, or healthcare worker. Medication errors include: drug omission (i.e., patient did not take a drug they were supposed to take), drug commission (i.e., patient taking a drug they were not supposed to take), duration error, dosing error, frequency error, route error, and timing error. We will record all drug errors identified and also report whether they resulted in harm.	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)
Medication error correction	Any medication error that is corrected.	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)
Death	All cause mortality	30 Days (after randomization); 6 months (after randomization)
Participant Pain	Assessed using the Brief Pain Inventory Short Form (BPI-SF)	7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization)
Acute hospital care	Composite of hospital re-admission and emergency department or urgent-care centre visit	30 Days (after randomization); 6 months (after randomization)
All-cause hospital days	If a patient is admitted to the hospital for any reason anytime between midnight and 23:59 on a given day, this will count as a day in hospital.	30 Days (after randomization); 6 months (after randomization)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health services utilization-related costs	Data on hospital re-admission, healthcare utilization, and costs of health service utilization will be obtained from the Institute for Clinical Evaluative Sciences (ICES) data repository	30 Days (after randomization); 6 months (after randomization)
Patient level cost of recovery	Assessment performed using the Ambulatory Home Care Record	30 Days (after randomization)
Re-operation	Any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection)	30 Days (after randomization); 6 months (after randomization)
Arrythmia resulting in electrical cardioversion	Arrythmia resulting in electrical cardioversion	30 Days (after randomization); 6 months (after randomization)
Acute renal failure resulting in dialysis	Acute renal failure resulting in dialysis	30 Days (after randomization); 6 months (after randomization)
Respiratory failure	Patient intubated or put on bilevel positive airway pressure (BiPAP).	30 Days (after randomization); 6 months (after randomization)
Infection	Infection	30 Days (after randomization); 6 months (after randomization)
Surgical site infection		30 Days (after randomization); 6 months (after randomization)
Life-threatening bleed		30 Days (after randomization); 6 months (after randomization)
Major bleed		30 Days (after randomization); 6 months (after randomization)
Critical organ bleed		30 Days (after randomization); 6 months (after randomization)
Ileus		30 Days (after randomization); 6 months (after randomization)
Myocardial Infarction		30 Days (after randomization); 6 months (after randomization)
Clinically important atrial fibrillation		30 Days (after randomization); 6 months (after randomization)
Symptomatic proximal venous thrombo-embolism		30 Days (after randomization); 6 months (after randomization)
Stroke		30 Days (after randomization); 6 months (after randomization)
Non-fatal cardiac arrest		30 Days (after randomization); 6 months (after randomization)
Clostridium difficile-associated diarrhea		30 Days (after randomization); 6 months (after randomization)
Indwelling device		30 Days (after randomization); 6 months (after randomization)
COVID-19 Infection		30 Days (after randomization); 6 months (after randomization)
Delirium	Positive history of delirium in hospital health records, positive 3D-CAM assessment, or FAM-CAM assessment. Assessments performed by telephone or in person.	30 Days (after randomization); 6 months (after randomization)
Surgeon, family physician, or specialist in-person clinic visit		30 Days (after randomization); 6 months (after randomization)
Sepsis		30 Days (after randomization); 6 months (after randomization)
Acute Heart Failure		30 Days (after randomization); 6 months (after randomization)
Surgeon, family physician, or specialist virtual visit		30 Days (after randomization); 6 months (after randomization)

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: McMaster University; Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: PJ Devereaux, PhD, McMaster University, Population Health Research Institute; Principal Investigator: Michael McGillion, PhD, McMaster University, Population Health Research Institute

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: CMAJ Open. 2021 Jun 18;9(2):E680.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): October 28, 2020
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Remote monitoring; Virtual care; Days alive at home
• Other Study ID Numbers: v5.0, 2020.09.12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritises access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee. Data are available to the journal for evaluation of reported analyses. Regarding the ICES data, while data sharing agreements prohibit ICES from making the data set publicly available, access can be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No