Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 Trial

NCT05171569 | Active Not Recruiting DMC

• 1 other identifier: v2.0_2025-01-25
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Surgery

Keywords

Virtual care

Outcome Measures

Primary Outcomes (2)

• Index hospital length of stay

  Length of stay from randomization until discharge from the index hospitalization (measured in days and hours)

  30 Days post randomization

• Acute hospital care (composite of hospital readmission and emergency department visit)

  Acute-hospital care is a composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.

  30 Days post randomization

Secondary Outcomes (8)

• Hospital readmission

  30 days post randomization

• Emergency department visit (includes urgent care centre visit)

  30 days post randomization

• Medication error detection

  30 days post randomization

• Medication error correction

  30 days post randomization

• Surgical site infection

  30 days post randomization

Other Outcomes (6)

• Infection

  30 days post randomization

• Re-operation

  30 days post randomization

• Composite of myocardial infarction, acute heart failure, and arrhythmia that results in acute hospital care

  30 days post randomization

Study Arms (2)

Virtual Care with Remote Automated Monitoring

EXPERIMENTAL

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.

Device: Virtual care with remote automated monitoring (RAM)

Standard Care

NO INTERVENTION

Standard post surgical care per treating institution.

Interventions

Virtual care with remote automated monitoring (RAM) DEVICE

Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.

Virtual Care with Remote Automated Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Population Health Research Institute: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (2)

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

Related Publications (1)

• Ofori S, McGillion MH, Borges FK, Ouellette C, Patel A, Conen D, Marcucci M, Wang MK, Park LJ, Bell C, Lounsbury J, Nagatani K, Tandon V, Wilkieson TJ, Wyne A, Harvey V, Harrison S, Nenshi R, Bogach J, Harlock J, Cadeddu M, Forbes S, Haider S, Mirza RD, Narang S, Reade CJ, Tushinski DM, Raut A, Raza S, Scott T, Adili A, Petch J, Devereaux PJ. Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial. JMIR Res Protoc. 2025 Jun 2;14:e72672. doi: 10.2196/72672.

  PMID: 40456137 DERIVED

Study Officials

• Michael McGillion, PhD

  McMaster University, Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• PJ Devereaux, M.D, PhD

  McMaster University, Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: December 29, 2021
• Study Start: December 28, 2021
• Primary Completion: November 30, 2024
• Study Completion: May 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)