Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial
- Conditions
- SurgeryPerioperative Complication
- Interventions
- Combination Product: Virtual care with remote automated monitoring
- Registration Number
- NCT04876950
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology-2 (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 45-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 45 days after randomization include 1) days in hospital; 2) index length of hospital stay; 3) hospital re-admission; 4) emergency department visit; 5) medication error detection; 6) medication error correction; and 7) surgical site infection. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 45 days. We will also assess optimal management of long-term health by evaluating among self-reported current smokers and those with atherosclerotic disease, whether patients are taking classes of efficacious medications at 45 days post randomization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- are ≥40 years of age;
- will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and
- provide informed consent to participate.
- planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery;
- are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a language barrier or a cognitive, visual, or hearing impairment; or
- reside in an area without cellular network coverage.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Care with Remote Automated Monitoring Virtual care with remote automated monitoring Patients randomized to the PVC-RAM-2 intervention will take biophysical measurements with the RAM technology and complete a daily recovery survey for 14 days after index hospital discharge, and nurses will review these results daily. Through scheduled video visits, patients will virtually interact with a nurse on days 1, 3, 7 and 14, and a physician on days 1 and 14. Patients will take a photograph of their wound daily for the first 7 days on the program, and nurses will review these pictures. 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, they will escalate care to a pre-assigned and available physician. Two 7-day extensions to the intervention will be possible, based on the patient's need for continued support. This decision will be based on standardized criteria.
- Primary Outcome Measures
Name Time Method Acute-hospital care 45 days post randomization Composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.
- Secondary Outcome Measures
Name Time Method Days in hospital 45 days post randomization Total number of days in hospital from randomization to 45 days post-randomization, including index hospital stay and any hospital readmission (s). A day in hospital is counted if a participant spends 1 minute of any day admitted to hospital.
Index length of hospital stay 45 days post randomization Length of hospital stay calculated from time of surgery completion (i.e., time of surgical wound closure) until discharge from the index hospitalization (measured in days and hours).
Hospital readmission 45 days post randomization Patient admission to an acute-care hospital.
Medication error detection 45 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.
Emergency department visit 45 days post randomization Patient visit to an emergency department.
Moderate to severe pain 15 and 45 days post randomization Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).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.
Medication error correction 45 days post randomization Any medication error that is corrected.
Optimal pharmacological management for patients with atherosclerotic disease 45 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 45 days (i.e., an antiplatelet or anticoagulant drug; an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker; and a statin).
Optimal pharmacological management self-reported current smokers 45 days post randomization Among patient who self-report to be current smokers at baseline, we will assess if patients are receiving pharmacological smoking cessation interventions at 45 days after randomization.
Surgical site infection 45 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).
Pain of any severity 15 and 45 days post randomization Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).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).
Trial Locations
- Locations (2)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Juravinski Hospital
🇨🇦Hamilton, Ontario, Canada