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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344665
Recruitment Status : Active, not recruiting
First Posted : April 14, 2020
Last Update Posted : July 23, 2021
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
McMaster University
Information provided by (Responsible Party):
Population Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Surgery Perioperative Complication COVID Other: Virtual Care and Remote Automated Monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 905 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial
Actual Study Start Date : April 23, 2020
Actual Primary Completion Date : October 28, 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
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.

No Intervention: Standard Care



Primary Outcome Measures :
  1. Days alive at home [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    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.


Secondary Outcome Measures :
  1. Hospital re-admission [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  2. Emergency Department visit [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  3. Urgent Care centre visit [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  4. Brief acute hospital care [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  5. Medication error detection [ Time Frame: 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 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.

  6. Medication error correction [ Time Frame: 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) ]
    Any medication error that is corrected.

  7. Death [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    All cause mortality

  8. Participant Pain [ Time Frame: 7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization) ]
    Assessed using the Brief Pain Inventory Short Form (BPI-SF)

  9. Acute hospital care [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    Composite of hospital re-admission and emergency department or urgent-care centre visit

  10. All-cause hospital days [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    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.


Other Outcome Measures:
  1. Health services utilization-related costs [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    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

  2. Patient level cost of recovery [ Time Frame: 30 Days (after randomization) ]
    Assessment performed using the Ambulatory Home Care Record

  3. Re-operation [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    Any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection)

  4. Arrythmia resulting in electrical cardioversion [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    Arrythmia resulting in electrical cardioversion

  5. Acute renal failure resulting in dialysis [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    Acute renal failure resulting in dialysis

  6. Respiratory failure [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    Patient intubated or put on bilevel positive airway pressure (BiPAP).

  7. Infection [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    Infection

  8. Surgical site infection [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  9. Life-threatening bleed [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  10. Major bleed [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  11. Critical organ bleed [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  12. Ileus [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  13. Myocardial Infarction [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  14. Clinically important atrial fibrillation [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  15. Symptomatic proximal venous thrombo-embolism [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  16. Stroke [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  17. Non-fatal cardiac arrest [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  18. Clostridium difficile-associated diarrhea [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  19. Indwelling device [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  20. COVID-19 Infection [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  21. Delirium [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
    Positive history of delirium in hospital health records, positive 3D-CAM assessment, or FAM-CAM assessment. Assessments performed by telephone or in person.

  22. Surgeon, family physician, or specialist in-person clinic visit [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  23. Sepsis [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  24. Acute Heart Failure [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]
  25. Surgeon, family physician, or specialist virtual visit [ Time Frame: 30 Days (after randomization); 6 months (after randomization) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344665


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada
Canada
Hamilton General Hospital
Hamilton, Canada
Juravinski Hospital
Hamilton, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Canada
Kingston Health Sciences Centre
Kingston, Canada
London Health Sciences Centre
London, Canada
Sponsors and Collaborators
Population Health Research Institute
Hamilton Health Sciences Corporation
McMaster University
Investigators
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Principal Investigator: Michael McGillion, PhD McMaster University, Population Health Research Institute
Principal Investigator: PJ Devereaux, PhD McMaster University, Population Health Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.

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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT04344665    
Other Study ID Numbers: v5.0, 2020.09.12
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Population Health Research Institute:
Virtual care
Remote monitoring
Days alive at home