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Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) -2 Trial (PVC-RAM-2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04876950
Recruitment Status : Not yet recruiting
First Posted : May 7, 2021
Last Update Posted : October 3, 2022
Sponsor:
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)-2 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 acute-hospital care 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. Secondary outcomes at 30 days after randomization include 1) hospital re-admission; 2) emergency department visit; 3) medication error detection; 4) medication error correction; and 5) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 7, 15, and 30 days. We will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease whether patients are taking classes of efficacious medications at 30 days.

Condition or disease Intervention/treatment Phase
Surgery Perioperative Complication Combination Product: Virtual care with remote automated monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 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)-2 Trial
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Care with Remote Automated Monitoring
Patients randomized to the PVC-RAM-2 intervention will take biophysical measurements with the RAM technology, complete a daily recovery survey, complete video visits with a virtual care clinical team, and take would photos during the 30 days after randomization. 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.
Combination Product: Virtual care with remote automated monitoring
Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.

No Intervention: Standard Care
Standard post-surgical care.



Primary Outcome Measures :
  1. Acute-hospital care [ Time Frame: 30 days post randomization ]
    Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.


Secondary Outcome Measures :
  1. Hospital readmission [ Time Frame: 30 days post randomization ]
    Patient admission to an acute-care hospital.

  2. Emergency department visit [ Time Frame: 30 days post randomization ]
    Patient visit to an emergency department.

  3. Medication error detection [ Time Frame: 30 days post randomization ]
    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.

  4. Medication error correction [ Time Frame: 30 days post randomization ]
    Any medication error that is corrected.

  5. Surgical site infection [ Time Frame: 30 days post randomization ]
    Surgical site infection is an infection that occurs within 30 days after randomization and involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional).

  6. Pain of any severity [ Time Frame: 7, 15, and 30 days post randomization ]
    Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).19 The BPI-SF includes four 11-point numeric rating scales (NRS) of pain intensity, which measure "average", "least", and "worst" pain intensity in the past 24 hours (hrs.), respectively, as well as pain intensity "now" (0= no pain, 10= pain as bad as you can imagine).

  7. Moderate to severe pain [ Time Frame: 7, 15, and 30 days post randomization ]
    Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).19 The BPI-SF includes four 11-point numeric rating scales (NRS) of pain intensity, which measure "average", "least", and "worst" pain intensity in the past 24 hours (hrs.), respectively, as well as pain intensity "now" (0= no pain, 10= pain as bad as you can imagine). Pain is of moderate or greater severity is defined by a score of ≥4/10 on a standard numeric rating scale (NRS) for pain.

  8. Optimal pharmacological management for patients with atherosclerotic disease [ Time Frame: 30 days post randomization ]
    Among patients with atherosclerotic disease, we will also assess optimal pharmacological management based upon whether patients are taking 0, 1, 2, or 3 of the following classes of efficacious medications at 30 days (i.e., an antiplatelet or anticoagulant drug; an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker; and a statin).


Other Outcome Measures:
  1. Health services utilization-related costs [ Time Frame: 30 days post 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. Administrative databases used to describe the health service utilization include: 1. Registered Persons Database (RPDB) - demographics and vital statistics of all legal residents of Ontario; 2. Discharge Abstract Database - records of inpatient hospitalizations from the Canadian Institute for Health Information (CIHI); 3. Ontario Health Insurance Plan (OHIP) Database - physician billing claims, and the National Ambulatory Care Reporting System - information on emergency department visits from CIHI.

  2. Patient-level cost of recovery [ Time Frame: 30 days post randomization ]
    The Ambulatory and Home Care Record (AHCR) will be used to comprehensively measure patient-level costs of illness from a societal perspective. This approach gives equal consideration to health system costs and costs borne by patients and unpaid caregivers (e.g., family members, friends). AHCR items can be categorized as publicly financed (e.g., public sector paid resources) or privately financed care (e.g., all out-of-pocket and third-party insurance payments, and time costs incurred by caregiver). Face validity and reliability of the AHCR is well established in multiple groups, including surgical patients.

  3. Infection [ Time Frame: 30 days post randomization ]
    Infection is defined as a pathologic process caused by the invasion of normally sterile tissue, fluid, or body cavity by pathogenic or potentially pathogenic organisms.

  4. Re-operation [ Time Frame: 30 days post randomization ]
    Re-operation refers to any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection) that is related to the index surgery.

  5. composite of myocardial infarction, acute heart failure, arrhythmia that results in patient presenting to an emergency department/urgent care centre or being admitted to hospital. [ Time Frame: 30 days post randomization ]

    Myocardial infarction: 4th Universal definition of myocardial infarction.

    Acute Heart Failure: The definition of acute heart failure requires at least one of the following clinical signs (i.e., elevated jugular venous pressure, respiratory rales or crackles, crepitations, or presence of S3) with at least one of the following:

    1. radiographic findings of vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema, OR
    2. heart failure treatment with a diuretic and documented clinical improvement.

    Arrhythmia that results in patient presenting to an emergency department/urgent care centre or being admitted to hospital: Any Arrhythmia that results in patient presenting to an emergency department/urgent care centre or being admitted to hospital.


  6. Death [ Time Frame: 30 days post randomization ]
    All cause mortality.

  7. COVID Infection [ Time Frame: 30 days post randomization ]
    Any laboratory confirmed evidence of COVID-19 infection.

  8. surgeon, family physician, or specialist in-person visit [ Time Frame: 30 days post randomization ]
    Patient has a in-person clinical visit with a surgeon, family physician, or specialist.

  9. surgeon, family physician, or specialist virtual clinic visit [ Time Frame: 30 days post randomization ]
    Patient has a virtual clinical visit with a surgeon, family physician, or specialist.

  10. moderate-to-severe persistent post-surgical pain [ Time Frame: 6 months post randomization ]
    Persistent post-surgical pain at has been adopted by the proposed classification for chronic post-surgical pain established by the International Association for the Study of Pain (IASP). A patient will meet the primary outcome if: 1) the patient reports non-zero pain (NRS pain score >0 at rest) in the last 24-hours, 2) located around the surgical incision (i.e., axilla, medial arm, shoulder, or chest wall on the side of surgery), 3) at 3-months after surgery (IASP's time required for normal healing from injury), 4) with no other identifiable cause of pain (e.g., no pre-existing pain condition, infection, or malignancy). Pain is of moderate or greater severity is defined by a score of ≥4/10 on a standard numeric rating scale (NRS) for pain.



Information from the National Library of Medicine

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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 inpatient semi-urgent, urgent, or emergency surgery and the most responsible physician has decided to discharge the patient;
  3. are on the day of being discharged home or are within 24 hours after discharge home without having obtained acute hospital care since discharge; and
  4. provide informed consent to participate.

Exclusion Criteria:

  1. went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;
  2. are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to cognitive, visual, or hearing impairment; or
  3. reside in an area without cellular network coverage.

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): NCT04876950


Contacts
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Contact: Valerie Harvey 905-527-4322 ext 40793 valerie.harvey@phri.ca

Locations
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Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada
Contact: Krysten Gregus       gregusk@hhsc.ca   
Principal Investigator: John Harlock, M.D         
Principal Investigator: Sultan Chaudhry, M.D         
Juravinski Hospital
Hamilton, Ontario, Canada
Contact: Kelly Lawrence       lawrenceke@hhsc.ca   
Principal Investigator: Ameen Patel, M.D         
Principal Investigator: Flavia Borges, M.D         
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Contact: Faraaz Quraishi       quraishif@HHSC.CA   
Principal Investigator: Vikas Tandon, M.D         
Principal Investigator: Rahima Nenshi, M.D         
Principal Investigator: Anthony Adili, M.D         
Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Michael McGillion, PhD McMaster University, Population Health Research Institute
Principal Investigator: PJ Devereaux, M.D, PhD McMaster University, Population Health Research Institute
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT04876950    
Other Study ID Numbers: 1.0.2021.04.30
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Acute hospital care