Virtual Care + RAM for Post-Surgery Complications

(PVC-RAM-2 Trial)

Recruiting at 2 trial locations

Overseen By Stephanie Harrison

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Disqualifiers: Rehabilitation, Communication impairment, No network, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual care with remote automated monitoring (RAM) reduces complications after surgery compared to standard care. The focus is on minimizing hospital visits and improving recovery for patients who have undergone semi-urgent, urgent, or emergency surgeries. Participants in the experimental group will use technology to monitor their health and interact with healthcare professionals through video calls. Ideal candidates are adults who have recently had surgery and expect to remain in the hospital for at least two days. As an unphased trial, this study provides patients the opportunity to contribute to innovative healthcare solutions that could enhance post-surgery recovery and shorten hospital stays.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual care with remote automated monitoring is safe for post-surgery patients?

Research has shown that Virtual Care with Remote Automated Monitoring (RAM) is generally safe for patients. This method involves monitoring vital signs, such as heart rate and blood pressure, after surgery. Studies have found that it can help patients spend more days at home post-surgery, indicating good tolerance. The research available has reported no major safety issues, suggesting that RAM is a safe option for those recovering from surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual care with remote automated monitoring (RAM) for post-surgery complications because it offers a proactive, tech-driven approach to patient recovery. Unlike standard care, which typically involves in-person follow-ups and relies heavily on patient self-reporting, this method uses RAM technology to continuously track biophysical markers and daily recovery surveys. This allows for early detection of potential issues, enabling timely intervention by healthcare professionals through virtual check-ins. The integration of daily wound photography and real-time data analysis can help catch complications before they become severe, improving recovery outcomes and patient safety.

What evidence suggests that virtual care with remote automated monitoring is effective for post-surgery complications?

Research has shown that virtual care using remote automated monitoring (RAM), which participants in this trial may receive, can greatly improve recovery after surgery. One study found that patients using RAM technology spent more days at home within 31 days after being discharged from non-elective surgery. This method also helps catch medication mistakes and reduces the chances of needing to return to the hospital, a common occurrence after surgery. By monitoring patients' vital signs and symptoms remotely, RAM can quickly identify potential issues and lessen the need for emergency room visits. This setup aims to enhance recovery and smooth the transition to home. Meanwhile, participants in the standard care arm will receive post-discharge care according to the standard of care at the hospital where they undergo surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Sandra Ofori, M.D., PhD

Principal Investigator

Hamilton Health Sciences, Population Health Research Institute

Michael McGillion, PhD

Principal Investigator

McMaster University, Population Health Research Institute

PJ Devereaux, M.D, PhD

Principal Investigator

McMaster University, Population Health Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 40 who've had semi-urgent, urgent, or emergency surgery and are being discharged. They must be able to use a tablet computer for communication and surveys without cognitive, visual, or hearing issues. Those in rehab more than 7 days post-surgery or living without cell coverage can't join.

Inclusion Criteria

are on the day of being discharged home or are within 24 hours after discharge home without having obtained acute hospital care since discharge; and

I had an urgent surgery and my doctor has decided I can be discharged.

I am 40 years old or older.

Exclusion Criteria

You live in an area where there is no cell phone service.

I can communicate and use a tablet for surveys or interviews despite any impairments.

I spent over a week in rehab after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual care with remote automated monitoring (RAM) technology for 14 days after index hospital discharge, including biophysical measurements and daily recovery surveys.

2 weeks

Scheduled video visits with a nurse on days 1, 3, 7, and 14, and with a physician on days 1 and 14

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on acute-hospital care and secondary outcomes over a 45-day period.

45 days

Extension

Two 7-day extensions to the intervention are possible based on the patient's need for continued support.

Up to 2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual care with remote automated monitoring

Trial Overview The PVC-RAM-2 Trial tests if virtual care with remote automated monitoring tech is better than standard care after surgery. It looks at hospital visits within 30 days of discharge and checks medication errors and surgical site infections. Pain levels will also be monitored up to a month later.

How Is the Trial Designed?

Group I: Virtual Care with Remote Automated Monitoring Experimental Treatment 1 Intervention

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.

Group II: Standard Care Active Control 1 Intervention

Patients randomized to standard care will receive post discharge care as per the standard of care at the hospital where they undergo surgery.

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

Published Research Related to This Trial

A user testing study involving 37 participants (26 nurses and 11 patients) showed high acceptance and satisfaction with the Philips Guardian and eTrAC systems for remote monitoring and virtual care after cardiac and major vascular surgeries.

Most participants were able to complete tasks independently, indicating good comprehension of the systems, although some required additional support for specific features, highlighting the need for further practice to enhance proficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Remote Automated Monitoring and Virtual Hospital-to-Home Care System Following Cardiac and Major Vascular Surgery: User Testing Study. McGillion, M., Ouellette, C., Good, A., et al.[2020]

In a study involving 905 adults discharged after non-elective surgery, virtual care with remote automated monitoring (RAM) did not significantly increase the number of days alive at home compared to standard care, with an average of 29.7 days versus 29.5 days.

However, the virtual care group had a lower rate of acute hospital care (22.0% vs. 27.3%) and reported less pain at 7, 15, and 30 days post-discharge, indicating potential benefits in managing recovery and reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial. McGillion, MH., Parlow, J., Borges, FK., et al.[2021]

Continuous multiparameter remote automated monitoring (CM-RAM) devices can significantly enhance virtual patient care by continuously tracking multiple health indicators, such as oxygen saturation and heart rate, which allows for early detection of health issues.

The integration of CM-RAM technologies can generate large amounts of data that can be used to develop algorithms for timely clinician responses, potentially revolutionizing how cardiovascular patients are monitored and treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Wellness Monitoring: Continuous Multiparameter Remote Automated Monitoring of Patients. McGillion, MH., Allan, K., Ross-Howe, S., et al.[2022]

This study will monitor 114 adult patients after non-cardiac surgery using a wearable sensor for 72 hours to detect hemodynamic, respiratory, and temperature abnormalities, aiming to improve postoperative care.

The researchers hypothesize that remote monitoring with the wearable device will identify vital sign abnormalities more effectively and quickly than traditional nurse follow-ups, potentially leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for postoperative complications by continuous monitoring: protocol for the Biobeat-Postop cohort study. Paternot, A., Aegerter, P., Martin, A., et al.[2022]

Modern digital tools, such as mobile apps and teleconferencing, can enhance the monitoring of patients after ambulatory surgery, helping to detect postoperative complications that traditional hospital methods might miss.

These digital solutions offer various advantages, like convenience and real-time communication, but also come with limitations that need to be considered for effective patient surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital tools for ambulatory surgery patient surveillance and beyond…. Raspado, O.[2021]

The PVC-RAM trial is a randomized controlled study involving 900 adults discharged after nonelective surgery, comparing the effectiveness of virtual care with remote automated monitoring (RAM) against standard care in improving patient outcomes post-discharge.

The primary goal is to increase the number of days patients remain alive at home within 30 days of surgery, potentially providing valuable insights for post-surgical care during and after the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial. McGillion, MH., Parlow, J., Borges, FK., et al.[2021]

Citations

1. bmj.com bmj.com/content/374/bmj.n2209

Post-discharge after surgery Virtual Care with Remote ... Virtual care with RAM compared with standard care increases days alive at home within 31 days of discharge after non-elective surgery in adults.

2. researchprotocols.org researchprotocols.org/2025/1/e72672/

Impact of Virtual Care With Remote Automated Monitoring ... The goal is to optimize safe discharge and patient outcomes while addressing significant systemic challenges like bed capacity and surgical ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05171569

Post Discharge After Surgery Virtual Care With Remote ... Secondary outcomes at 30 days after randomization include: 1) hospital re-admission; 2) emergency department visit; 3) medication error detection;4) medication ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074825003154

Impact of Virtual Care With Remote Automated Monitoring ... The goal is to optimize safe discharge and patient outcomes while addressing significant systemic challenges like bed capacity and surgical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04876950

NCT04876950 | Post Discharge After Surgery Virtual Care ... Secondary outcomes at 45 days after randomization include 1) days in hospital; 2) index length of hospital stay; 3) hospital re-admission; 4) emergency ...

6. withpower.com withpower.com/trial/phase-2-2022-72b62?lat=36.65114&lng=-97.3517

Virtual Care + RAM for Post-Surgery Complications The studies suggest that Virtual Care with Remote Automated Monitoring (RAM) is generally safe for humans, as it involves monitoring vital signs like heart rate ...