COVID, Perioperative Complication, Surgery
Conditions
Keywords
Virtual care, Remote monitoring, Days alive at home
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.
Interventions
OTHERVirtual 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.
Sponsors
Hamilton Health Sciences Corporation
McMaster University
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department visit | 30 Days (after randomization); 6 months (after randomization) | — |
| Urgent Care centre visit | 30 Days (after randomization); 6 months (after randomization) | — |
| Brief acute hospital care | 30 Days (after randomization); 6 months (after randomization) | — |
| 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. |
| Hospital re-admission | 30 Days (after randomization); 6 months (after randomization) | — |
| Death | 30 Days (after randomization); 6 months (after randomization) | All cause mortality |
| 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) |
| Acute hospital care | 30 Days (after randomization); 6 months (after randomization) | Composite of hospital re-admission and emergency department or urgent-care centre visit |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ileus | 30 Days (after randomization); 6 months (after randomization) | — |
| Myocardial Infarction | 30 Days (after randomization); 6 months (after randomization) | — |
| Health services utilization-related costs | 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 |
| Patient level cost of recovery | 30 Days (after randomization) | Assessment performed using the Ambulatory Home Care Record |
| Re-operation | 30 Days (after randomization); 6 months (after randomization) | Any surgical procedure undertaken for any reason (e.g., wound dehiscence, infection) |
| Arrythmia resulting in electrical cardioversion | 30 Days (after randomization); 6 months (after randomization) | Arrythmia resulting in electrical cardioversion |
| Acute renal failure resulting in dialysis | 30 Days (after randomization); 6 months (after randomization) | Acute renal failure resulting in dialysis |
| Clinically important atrial fibrillation | 30 Days (after randomization); 6 months (after randomization) | — |
| Infection | 30 Days (after randomization); 6 months (after randomization) | Infection |
| Delirium | 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. |
| Surgeon, family physician, or specialist in-person clinic visit | 30 Days (after randomization); 6 months (after randomization) | — |
| Sepsis | 30 Days (after randomization); 6 months (after randomization) | — |
| Acute Heart Failure | 30 Days (after randomization); 6 months (after randomization) | — |
| Surgeon, family physician, or specialist virtual visit | 30 Days (after randomization); 6 months (after randomization) | — |
| Respiratory failure | 30 Days (after randomization); 6 months (after randomization) | Patient intubated or put on bilevel positive airway pressure (BiPAP). |
| Symptomatic proximal venous thrombo-embolism | 30 Days (after randomization); 6 months (after randomization) | — |
| Stroke | 30 Days (after randomization); 6 months (after randomization) | — |
| Non-fatal cardiac arrest | 30 Days (after randomization); 6 months (after randomization) | — |
| Clostridium difficile-associated diarrhea | 30 Days (after randomization); 6 months (after randomization) | — |
| Indwelling device | 30 Days (after randomization); 6 months (after randomization) | — |
| COVID-19 Infection | 30 Days (after randomization); 6 months (after randomization) | — |
| Surgical site infection | 30 Days (after randomization); 6 months (after randomization) | — |
| Life-threatening bleed | 30 Days (after randomization); 6 months (after randomization) | — |
| Major bleed | 30 Days (after randomization); 6 months (after randomization) | — |
| Critical organ bleed | 30 Days (after randomization); 6 months (after randomization) | — |
Countries
Canada
Outcome results
None listed