Virtual Care + RAM for Post-Surgery Recovery

(PVC-RAM-3 Trial)

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

2500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Virtual Care + RAM for Post-Surgery Recovery is an effective treatment?

The available research shows that Virtual Care + RAM can help patients recover better after surgery. For example, studies have been conducted to see if this treatment helps patients stay at home longer without needing to go back to the hospital after surgeries. One study focused on patients who had urgent surgeries and found that using Virtual Care + RAM might help them stay alive and at home longer compared to standard care. Another study looked at patients who had heart and major blood vessel surgeries and suggested that this treatment could improve their recovery by reducing complications and hospital readmissions. Overall, these studies suggest that Virtual Care + RAM can be a helpful way to support recovery after surgery. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for post-surgery recovery?

Research suggests that using virtual care with remote automated monitoring (RAM) can help patients stay at home longer after surgery by continuously tracking important health signs like heart rate and oxygen levels, allowing for early detection of potential issues. ^{1 2 3 4 5}

What safety data exists for virtual care with remote automated monitoring after surgery?

The safety data for virtual care with remote automated monitoring (RAM) after surgery is being evaluated in several studies. The PVC-RAM trial is assessing if this approach increases the number of days patients remain alive at home after nonelective surgeries. Another study focuses on the potential of RAM and virtual hospital-to-home care systems to improve outcomes following cardiac and major vascular surgeries, highlighting the complexity and risks of implementation. Additionally, the PVC-RAM-1 trial compares RAM technology to standard care for patients discharged after non-elective surgery during the COVID-19 pandemic. While continuous multiparameter RAM devices are being explored for their potential to enhance virtual patient care, the regulation and evaluation of these technologies vary, with many lacking comprehensive safety data. Overall, these studies aim to determine the effectiveness and safety of RAM technologies in post-surgery recovery. ^{1 2 3 5 6}

Is virtual care with remote automated monitoring (RAM) technology safe for humans?

Research on virtual care with remote automated monitoring (RAM) technology suggests it is generally safe for humans, as it is being used to monitor patients after surgeries and during pandemics to enhance safety and improve outcomes. However, the technology's regulation and evaluation can vary, and more comprehensive studies are needed to fully understand its safety profile. ^{1 2 3 5 6}

Is Virtual care with remote automated monitoring (RAM) a promising treatment for post-surgery recovery?

Yes, Virtual care with remote automated monitoring (RAM) is a promising treatment for post-surgery recovery. It can help patients stay at home longer after surgery by reducing the chances of needing to go back to the hospital. This treatment uses technology to keep an eye on important health signs like heart rate and oxygen levels, which helps doctors catch any problems early and respond quickly. This makes recovery safer and more comfortable for patients. ^{1 2 3 4 5}

How is the Virtual Care with Remote Automated Monitoring (RAM) treatment different from other post-surgery recovery treatments?

This treatment is unique because it uses technology to monitor patients remotely after surgery, allowing for continuous tracking of vital signs like heart rate and oxygen levels. This can help detect health issues early and reduce the need for hospital readmissions, which is different from standard care that typically involves in-person follow-ups. ^{1 2 3 4 5}

Research Team

PJ Devereaux, M.D, PhD

Principal Investigator

McMaster University, Population Health Research Institute

Michael McGillion, PhD

Principal Investigator

McMaster University, Population Health Research Institute

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. 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]

2. 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]

3. 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]

4. United States pubmed.ncbi.nlm.nih.gov

Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

Enhancing Safety During a Pandemic Using Virtual Care Remote Monitoring Technologies and UML Modeling. [2023]