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

Trial Summary

What is the purpose of this trial?

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.

Is Virtual Care with Remote Automated Monitoring (RAM) safe for humans?

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 and oxygen levels to quickly detect any issues. However, the technology's effectiveness and safety can depend on proper implementation and use. ^{1 2 3 4}

How is the Virtual Care + RAM treatment different from other treatments for post-surgery complications?

The Virtual Care + RAM treatment is unique because it uses remote automated monitoring (RAM) technology to continuously track multiple health parameters like oxygen levels and heart rate from home, allowing for early detection of complications and timely medical response, unlike traditional care which relies on in-person visits. ^{1 2 3 5 6}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial. [2021]

3. Canada 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Screening for postoperative complications by continuous monitoring: protocol for the Biobeat-Postop cohort study. [2022]

5. France pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Beyond Wellness Monitoring: Continuous Multiparameter Remote Automated Monitoring of Patients. [2022]