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SurgeryPVC-RAM-3NCT05171569

Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 Trial

A study testing Virtual care with remote automated monitoring (RAM) in people with Surgery, run by Population Health Research Institute at 2 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery
What is being tested?
Virtual care with remote automated monitoring (RAM)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
2 sitesCanada
Study dates
28 Dec 2021to 31 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • are ≥18 years of age;
  • are undergoing inpatient elective noncardiac surgery with an expected length of hospital stay ≤3 days after surgery; and
  • provide informed consent to participate.

Who cannot join

  • 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
  • reside in an area without cellular network coverage.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Hamilton General Hospital

    Hamilton, Ontario

  • Juravinski Hospital

    Hamilton, Ontario

Other trials in Canada

About this study

Official title: Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 (PVC-RAM-3) 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.

Conditions
Surgery
Being tested
Virtual care with remote automated monitoring (RAM)
Keywords
Virtual care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual care with remote automated monitoring (RAM)Device

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

Study groups in NCT05171569
Study groupRoleWhat they receive
Virtual Care with Remote Automated MonitoringExperimentalPatients 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.
Receives: Device: Virtual care with remote automated monitoring (RAM)
Standard CareNo interventionStandard post surgical care per treating institution.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Index hospital length of stay

    Length of stay from randomization until discharge from the index hospitalization (measured in days and hours)

    Measured: 30 Days post randomization

  2. Acute hospital care (composite of hospital readmission and emergency department visit)

    Acute-hospital care is a composite outcome of hospital re-admission and emergency department visit, which includes urgent-care centre visit.

    Measured: 30 Days post randomization

Secondary outcomes (8)

  1. Hospital readmission

    Patient admission to an acute-care hospital.

    Measured: 30 days post randomization

  2. Emergency department visit (includes urgent care centre visit)

    Patient visit to an emergency department, which includes urgent-care centre visit.

    Measured: 30 days post randomization

  3. Medication error detection

    Medication errors include mistakes in medication prescribing, transcribing, dispensing, administering, or monitoring due to preventable events or actions taken by a patient, caregiver, or healthcare worker. Medication errors include: drug omission (i.e., patient did not take a drug they were supposed to take), drug commission (i.e., patient taking a drug they were not supposed to take), duration error, dosing error, frequency error, route error, and timing error. We will record all drug errors identified.

    Measured: 30 days post randomization

  4. Medication error correction

    Any medication error that is corrected.

    Measured: 30 days post randomization

  5. Surgical site infection

    Surgical site infection is an infection that occurs within 30 days after randomization and involves the skin, subcutaneous tissue of the incision (superficial incisional), or the deep soft tissue (e.g., fascia, muscle) of the incision (deep incisional).

    Measured: 30 days post randomization

  6. Days in hospital

    Days in hospital

    Measured: 30 days post randomization

  7. Level of pain and pain related interference in recovery

    Pain intensity and related interference with usual daily activities, will be measured via the Brief Pain Inventory-Short Form (BPI-SF).4 The BPI-SF includes four 11-point numeric rating scales (NRS) of pain intensity, which measure "average", "least", and "worst" pain intensity in the past 24 hours (hrs.), respectively, as well as pain intensity "now" (0= no pain, 10= pain as bad as you can imagine). The BPI-SF interference subscale will also be used, which measures the degree to which pain interferes with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life (NRS for each item; 0=does not interfere, 10=completely interferes). A total interference score is determined by calculating the sum of these 7 items. The BPI-SF has strong psychometric properties with well-established reliability and validity across divergent surgical groups. Moderate to severe pain is defined by a score of ≥4/10 on a standard numeric rating scale (NRS) for pain.

    Measured: 15 and 30 days post randomization

  8. Optimization of medications for long-term health

    Among patients with atherosclerotic disease, we will also assess optimal pharmacological management based upon whether patients are taking 0, 1, 2, or 3 of the following classes of efficacious medications at 30 days (i.e., an antiplatelet or anticoagulant drug; an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker; and a statin). Among active smokers before surgery we will assess if patients are receiving pharmacological smoking cessation interventions at 30 days after randomization.

    Measured: 30 days post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start28 Dec 2021
  3. Primary completion30 Nov 2024
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171569
Sponsor's protocol ID
v2.0_2025-01-25
Acronym
PVC-RAM-3
Status last verified
Mar 2025
First submitted
10 Dec 2021
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ofori S, McGillion MH, Borges FK, Ouellette C, Patel A, Conen D, Marcucci M, Wang MK, Park LJ, Bell C, Lounsbury J, Nagatani K, Tandon V, Wilkieson TJ, Wyne A, Harvey V, Harrison S, Nenshi R, Bogach J, Harlock J, Cadeddu M, Forbes S, Haider S, Mirza RD, Narang S, Reade CJ, Tushinski DM, Raut A, Raza S, Scott T, Adili A, Petch J, Devereaux PJ. Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial. JMIR Res Protoc. 2025 Jun 2;14:e72672. doi: 10.2196/72672.

    PubMed 40456137

Questions about this trial

What is this clinical trial studying?

A study testing Virtual care with remote automated monitoring (RAM) in people with Surgery, run by Population Health Research Institute at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Index hospital length of stay (time frame: 30 Days post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05171569, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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