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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
905
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.
University of Alberta Hospital
Edmonton, Alberta, Canada
The Ottawa Hospital
Ottawa, Ontario, 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
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.
Time frame: 30 Days (after randomization); 6 months (after randomization)
Hospital re-admission
Time frame: 30 Days (after randomization); 6 months (after randomization)
Emergency Department visit
Time frame: 30 Days (after randomization); 6 months (after randomization)
Urgent Care centre visit
Time frame: 30 Days (after randomization); 6 months (after randomization)
Brief acute hospital care
Time frame: 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.
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 error correction
Any medication error that is corrected.
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)
Death
All cause mortality
Time frame: 30 Days (after randomization); 6 months (after randomization)
Participant Pain
Assessed using the Brief Pain Inventory Short Form (BPI-SF)
Time frame: 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
Time frame: 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.
Time frame: 30 Days (after randomization); 6 months (after randomization)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.