Virtual Care + RAM for Post-Surgery Recovery

(PVC-RAM-3 Trial)

Not currently recruiting at 1 trial location

Overseen By Stephanie Harrison, BAS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Disqualifiers: Language barrier, Cognitive impairment, 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: 15

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual care with remote automated monitoring (RAM) can improve recovery after elective surgeries not related to the heart. It compares patients using this virtual method to those receiving standard post-surgery care, focusing on hospital stay duration and the frequency of urgent medical needs. Participants will take health measurements at home, complete daily surveys, and have video check-ins with a medical team. This trial suits adults undergoing non-heart-related surgery who expect a hospital stay of three days or less. As an unphased trial, it offers a unique opportunity to explore innovative recovery methods and contribute to advancements in post-surgical care.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention evaluating medication use in patients with atherosclerotic disease and current smokers, so it's best to discuss your medications with the trial team.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is 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 recovery?

Research has shown that using virtual care with remote automated monitoring (RAM) is safe for patients after surgery. In past studies, RAM did not cause any major problems, and patients managed it well. Although RAM did not significantly increase the time patients spent at home, it helped identify medication mistakes and reduced pain. This indicates that the technology effectively catches issues early, enhancing patient safety. While researchers continue to test the RAM system, the evidence so far suggests it is a safe choice for recovery after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Care with Remote Automated Monitoring (RAM) for post-surgery recovery because it offers a new way to monitor patients remotely after they leave the hospital. Unlike standard care, which typically involves follow-up visits and self-reported symptoms, this approach uses technology to track vital signs and recovery progress in real-time. Patients take biophysical measurements and complete daily surveys, while healthcare providers can intervene quickly if any issues arise, potentially improving recovery outcomes. This method could make post-surgery care more responsive and personalized, addressing problems before they become serious.

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

This trial will compare virtual care with remote automated monitoring (RAM) to standard post-surgical care. Research has shown that virtual care with RAM allows patients to stay at home more days in the first month after surgery compared to traditional care. This method uses technology to monitor important health signs, aiming to make discharge safer and improve recovery. Participants in the virtual care arm will fill out daily surveys and have video calls with their healthcare team. If any health issues arise, a nurse can quickly contact a doctor. This approach aims to reduce hospital visits and catch medication mistakes early, making recovery smoother and safer. ^{1 2 3 4 5}

Who Is on the Research Team?

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 18 who've had elective noncardiac surgery with a hospital stay of ≤3 days expected. They must be able to give consent and use a tablet for communication. It's not for those with language barriers, cognitive issues, or living without cell coverage.

Inclusion Criteria

I am having a planned surgery that is not heart-related and I should be in the hospital for 3 days or less afterwards.

Patients provide informed consent to participate

Exclusion Criteria

Patients reside in an area without cellular network coverage

Patients 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive virtual care with remote automated monitoring technology for 14 days post-discharge

2 weeks

Daily virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 15 and 30 days post-randomization

4 weeks

Virtual assessments at 15 and 30 days

Long-term follow-up

Evaluation of optimal management of long-term health, including medication optimization and smoking cessation interventions

30 days post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• Virtual care with remote automated monitoring (RAM)

Trial Overview The study tests if virtual care using Remote Automated Monitoring (RAM) tech can shorten the hospital stay after surgery compared to standard care. It also looks at readmissions, ER visits, medication errors, infections, and pain within 30 days post-surgery.

How Is the Trial Designed?

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

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 II: Standard Care Active Control 1 Intervention

Standard post surgical care per treating institution.

Virtual care with remote automated monitoring (RAM) is already approved in Canada for the following indications:

Approved in Canada as Virtual care with remote automated monitoring for:

• Post-surgical care
• Monitoring after elective non-cardiac surgery

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Published Research Related to This Trial

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]

In a study of 59 patients who underwent either catheter ablation for atrial fibrillation or bariatric surgery, personal digital devices like Fitbits and KardiaMobile provided valuable data on activity levels and heart rhythms, highlighting their potential for remote patient monitoring.

Patients with palpitations after AF ablation had significantly lower daily step counts, and those who recorded atrial fibrillation episodes were more likely to receive new antiarrhythmic medications, suggesting that digital monitoring can help identify patients needing further intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices. Bartlett, VL., Ross, JS., Shah, ND., et al.[2022]

The study outlines a methodology for developing remote monitoring technology (RMT) aimed at improving patient safety during pandemics, particularly through virtual care technologies, highlighting the increasing need for such solutions during COVID-19.

A literature review identified gaps in current practices, leading to the creation of object-oriented models for RMT deployment, which are being used for educational purposes and to test new applications in a smart home laboratory setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Safety During a Pandemic Using Virtual Care Remote Monitoring Technologies and UML Modeling. Borycki, EM., Kushniruk, AW., Kletke, R., et al.[2023]

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]

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]

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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33653769/

Post Discharge after Surgery Virtual Care with Remote ... This trial will inform management of patients after discharge following surgery in the COVID-19 pandemic and offer insights for management of patients.

4. 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 ...

5. bmj.com bmj.com/content/bmj/374/bmj.n2209.full.pdf

Post-discharge after surgery Virtual Care with Remote ... OBJECTIVE. To determine if virtual care with remote automated monitoring (RAM) technology versus standard care increases days alive at home ...