Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial
- Conditions
- COVIDSurgeryPerioperative Complication
- Interventions
- Other: Virtual Care and Remote Automated Monitoring
- Registration Number
- NCT04344665
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 905
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Care and Remote Automated Monitoring Virtual Care and Remote Automated Monitoring -
- Primary Outcome Measures
Name Time Method Days alive at home 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
Name Time Method 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) 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.
Urgent Care centre visit 30 Days (after randomization); 6 months (after randomization) All-cause hospital days 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.
Hospital re-admission 30 Days (after randomization); 6 months (after randomization) Emergency Department visit 30 Days (after randomization); 6 months (after randomization) Brief acute hospital care 30 Days (after randomization); 6 months (after randomization) Death 30 Days (after randomization); 6 months (after randomization) All cause mortality
Acute hospital care 30 Days (after randomization); 6 months (after randomization) Composite of hospital re-admission and emergency department or urgent-care centre visit
Participant Pain 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)
Medication error correction 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.
Trial Locations
- Locations (7)
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Hamilton General Hospital
🇨🇦Hamilton, Canada
Juravinski Hospital
🇨🇦Hamilton, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Canada
London Health Sciences Centre
🇨🇦London, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Canada