Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-2 (PVC-RAM-2) Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Hamilton General Hospital
RECRUITING
Hamilton
Juravinski Hospital
RECRUITING
Hamilton
Contact Information
Primary
Stephanie Harrison
stephanie.harrison@phri.ca
905-594-0564
Backup
Valerie Harvey
valerie.harvey@phri.ca
905-594-0563
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2026-03
Participants
Target number of participants: 2000
Treatments
Experimental: 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.
No_intervention: Standard Care
Patients randomized to standard care will receive post discharge care as per the standard of care at the hospital where they undergo surgery.
Sponsors
Leads: Population Health Research Institute

This content was sourced from clinicaltrials.gov