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

NCT ID: NCT05171569

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2025-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Virtual Care with Remote Automated Monitoring

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.

Group Type: EXPERIMENTAL

Virtual care with remote automated monitoring (RAM)

Intervention Type: DEVICE

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

Standard Care

Standard post surgical care per treating institution.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual care with remote automated monitoring (RAM)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael McGillion, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Population Health Research Institute

PJ Devereaux, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Population Health Research Institute

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Juravinski Hospital

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 40456137 (View on PubMed)

Other Identifiers

v2.0_2025-01-25

Identifier Type: -

Identifier Source: org_study_id