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Completed

NCT Number: NCT04344665

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

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.

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Key information

Conditions

Surgery COVID Perioperative Complication

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Virtual Care and Remote Automated Monitoring

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • McMaster University

Registry information

Acronym: PVC-RAM

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 14, 2020
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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