NCT04344665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
905

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

April 23, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

April 9, 2020

Last Update Submit

February 2, 2024

Conditions

SurgeryPerioperative ComplicationCOVID

Keywords

Virtual careRemote monitoringDays alive at home

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

    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)

  • +5 more secondary outcomes

Other Outcomes (25)

  • Health services utilization-related costs

    30 Days (after randomization); 6 months (after randomization)

  • Patient level cost of recovery

    30 Days (after randomization)

  • Re-operation

    30 Days (after randomization); 6 months (after randomization)

  • +22 more other outcomes

Study Arms (2)

Virtual Care and Remote Automated Monitoring

EXPERIMENTAL
Other: Virtual Care and Remote Automated Monitoring

Standard Care

NO INTERVENTION

Interventions

Virtual Care and Remote Automated MonitoringOTHER

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.

Virtual Care and Remote Automated Monitoring

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are ≥40 years of age;
  • 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
  • provide informed consent to participate.

You may not qualify if:

  • 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;
  • went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;
  • 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
  • reside in an area without cellular network coverage and no home Wi-Fi.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Hamilton General Hospital

Hamilton, Canada

Location

Juravinski Hospital

Hamilton, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Canada

Location

Kingston Health Sciences Centre

Kingston, Canada

Location

London Health Sciences Centre

London, Canada

Location

Related Publications (2)

  • 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.

    PMID: 34593374DERIVED

  • 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.

    PMID: 33653769DERIVED

Study Officials

  • Michael McGillion, PhD

    McMaster University, Population Health Research Institute

    PRINCIPAL INVESTIGATOR

  • PJ Devereaux, PhD

    McMaster University, Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 14, 2020

Study Start

April 23, 2020

Primary Completion

October 28, 2020

Study Completion

June 2, 2021

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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.

Locations

CA(7)