Recruiting

PVC-RAM-2

Sponsor:

Population Health Research Institute

Code:

NCT04876950

Conditions

Surgery

Perioperative Complication

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Virtual care with remote automated monitoring

Study Details

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.

Conditions

Surgery

Perioperative Complication

Study ID

NCT04876950

Start date

Oct 4, 2024

Status verified date

Nov, 2024

Completion date

Mar, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. are ≥40 years of age;
2. will undergo or have undergone semi-urgent, urgent, or emergency surgery requiring expected hospital stay of ≥2 days; and
3. provide informed consent to participate.

Exclusion Criteria:

1. planned transfer to a rehabilitation or convalescent facility, or repatriation from trial hospital site to local community hospital following surgery;
2. 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
3. reside in an area without cellular network coverage.

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Virtual care with remote automated monitoring

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

Primary outcome measure

  • Acute-hospital care [ Time Frame: 45 days post randomization ]

Central Contacts and Locations

Central contacts

Stephanie Harrison

905-594-0564stephanie.harrison@phri.ca

Valerie Harvey

905-594-0563valerie.harvey@phri.ca

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada

Contacts

Krysten Gregus

gregusk@hhsc.ca

Juravinski Hospital

Recruiting

Hamilton, Ontario, Canada

Contacts

Kelly Lawrence

lawrenceke@hhsc.ca

More Information

Sponsor

Population Health Research Institute

Last update posted

Nov 15, 2024

Last verified

Nov, 2024

Keywords

  • Virtual care
  • Remote monitoring
  • Acute hospital care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2024-11-15.