Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 Trial (PVC-RAM-3)

Population Health Research Institute (PHRI)

Status: Active, not recruiting

Conditions: Surgery

Treatments: Device: Virtual care with remote automated monitoring (RAM)

Study type: Interventional

Funder types: Other

Identifiers

NCT05171569

v2.0_2025-01-25

Details and patient eligibility

About

The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM)-3 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 length of index hospital stay and use of acute hospital care (composite of hospital readmission and emergency department visit) after randomization, in adults who have undergone elective non cardiac surgery. Secondary outcomes at 30 days after randomization include: 1) hospital re-admission; 2) emergency department visit; 3) medication error detection;4) medication error correction; 5) surgical site infection; and 6) days in hospital. Additional secondary outcomes are pain of any severity, and moderate-to-severe pain assessed at 15 and 30 days after randomization. The investigators will also assess optimal management of long-term health by evaluating among patients with atherosclerotic disease and current smokers whether patients are taking classes of efficacious medications at 30 days.

Enrollment: 2,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. are ≥18 years of age;
2. are undergoing inpatient elective noncardiac surgery with an expected length of hospital stay ≤3 days after surgery; and
3. provide informed consent to participate.

Exclusion criteria

1. 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
2. reside in an area without cellular network coverage.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,500 participants in 2 patient groups

Virtual Care with Remote Automated Monitoring

Experimental group

Description:

Patients randomized to the PVC-RAM-3 intervention will take biophysical measurements with the RAM technology, complete a daily recovery survey, complete video visits with a virtual care clinical team, and take wound photos during the 14 days after discharge. 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.

Treatment:

Device: Virtual care with remote automated monitoring (RAM)

Standard Care

No Intervention group

Description:

Standard post surgical care per treating institution.