SurgeryPVC-RAMNCT04344665
Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial
A study testing Virtual Care and Remote Automated Monitoring in people with Surgery and Perioperative Complication, run by Population Health Research Institute at 7 sites in Canada.
Trial summary
The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) 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 days alive at home… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Surgery, Perioperative Complication, COVID
- What is being tested?
- Virtual Care and Remote Automated Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 905 participants
- Where
- 7 sitesCanada
- Study dates
- 23 Apr 2020to 2 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are ≥40 years of age;
- have undergone same-day or inpatient semi-urgent, urgent, or emergency surgery and are being discharged home or are within 24 hours after discharge home, as long as they have not had acute-hospital care since their discharge; and
- provide informed consent to participate.
Who cannot join
- underwent same-day surgery and the surgeon or anesthesiologist believe the case reflects a traditional same-day surgery case with a low likelihood of needing acute-hospital care;
- went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;
- are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a cognitive, language, visual, or hearing impairment; or
- reside in an area without cellular network coverage and no home Wi-Fi.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
University of Alberta Hospital
Edmonton, Alberta
Hamilton General Hospital
Hamilton
Juravinski Hospital
Hamilton
St. Joseph's Healthcare Hamilton
Hamilton
Kingston Health Sciences Centre
Kingston
London Health Sciences Centre
London
The Ottawa Hospital
Ottawa, Ontario
About this study
The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) 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 days alive at home during the 30-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. It will also determine, during the first 30 days, the effect of virtual care with RAM technology on several secondary outcomes, including: 1. hospital re-admission; 2. emergency department visit; 3. urgent-care centre visit; 4. acute-hospital care (i.e., a composite of hospital re-admission and emergency department or urgent-care centre visit) 5. brief acute-hospital care (i.e., acute-hospital care that lasts <24 hours); 6. all-cause hospital days; 7. medication error detection; 8. medication error correction; and 9. death. An additional secondary objective is to determine the effect of virtual care with RAM technology on pain at 7, 15, and 30 days and 6 months after randomization.
- Conditions
- Surgery, Perioperative Complication, COVID
- Being tested
- Virtual Care and Remote Automated Monitoring
- Keywords
- Virtual care, Remote monitoring, Days alive at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Care and Remote Automated MonitoringOther
Patients will measure daily vitals (blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, weight) with remote monitoring technology and complete recovery surveys daily in home after discharge from hospital. Patients will interact with a virtual nurse daily on days 1-15 and every other day from days 16-30. 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. Physicians will add or modify treatments as needed, and if required, they will have the patient come to an outpatient facility for evaluation or management. Via secure video or text messaging, patients will also have access to a virtual nurse at night, for any urgent issues.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Care and Remote Automated Monitoring | Experimental | Not described Receives: Other: Virtual Care and Remote Automated Monitoring |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive at home
Days alive at home are the number of days patients spend at their usual residence - be it a house or apartment, a group home or shelter, a seniors residence, or a nursing home - or at a community residence of a relative, friend, or acquaintance without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Thus, patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.
Measured: 30 Days (after randomization); 6 months (after randomization)
Secondary outcomes (10)
Hospital re-admission
Measured: 30 Days (after randomization); 6 months (after randomization)
Emergency Department visit
Measured: 30 Days (after randomization); 6 months (after randomization)
Urgent Care centre visit
Measured: 30 Days (after randomization); 6 months (after randomization)
Brief acute hospital care
Measured: 30 Days (after randomization); 6 months (after randomization)
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 and also report whether they resulted in harm.
Measured: Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Medication error correction
Any medication error that is corrected.
Measured: Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Death
All cause mortality
Measured: 30 Days (after randomization); 6 months (after randomization)
Participant Pain
Assessed using the Brief Pain Inventory Short Form (BPI-SF)
Measured: 7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization)
Acute hospital care
Composite of hospital re-admission and emergency department or urgent-care centre visit
Measured: 30 Days (after randomization); 6 months (after randomization)
All-cause hospital days
If a patient is admitted to the hospital for any reason anytime between midnight and 23:59 on a given day, this will count as a day in hospital.
Measured: 30 Days (after randomization); 6 months (after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start23 Apr 2020
- Primary completion28 Oct 2020
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 905 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, McMaster University
- Responsible party
- Sponsor
- Investigators
- Michael McGillion, PhD, Principal investigator, McMaster University, Population Health Research InstitutePJ Devereaux, PhD, Principal investigator, McMaster University, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344665
- Sponsor's protocol ID
- v5.0, 2020.09.12
- Acronym
- PVC-RAM
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritises access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee. Data are available to the journal for evaluation of reported analyses. Regarding the ICES data, while data sharing agreements prohibit ICES from making the data set publicly available, access can be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS.
Publications
McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Ouellette C, Bird M, Ofori S, Roshanov PS, Patel A, Yang H, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Conen D, Harvey V, Lounsbury J, Mian R, Bangdiwala SI, Arellano R, Scott T, Guyatt GH, Gao P, Graham M, Nenshi R, Forster AJ, Nagappa M, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Harlock J, Meyer RM, Taylor DA, Shanthanna H, Schlachta CM, Parry N, Pichora DR, Yousuf H, Peter E, Lamy A, Petch J, Moloo H, Sehmbi H, Waggott M, Shelley J, Belley-Cote EP, Devereaux PJ; PVC-RAM-1 Investigators. Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial. BMJ. 2021 Sep 30;374:n2209. doi: 10.1136/bmj.n2209.
PubMed 34593374McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Yang H, Patel A, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Ouellette C, Bird M, Ofori S, Conen D, Roshanov PS, Harvey V, Guyatt GH, Le Manach Y, Bangdiwala SI, Arellano R, Scott T, Lounsbury J, Taylor DA, Nenshi R, Forster AJ, Nagappa M, Lamy A, Peter E, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, Paul J, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Schlachta CM, Shelley J, Harlock J, Meyer RM, Graham M, Shanthanna H, Parry N, Pichora DR, Yousef H, Moloo H, Sehmbi H, Waggott M, Belley-Cote EP, Whitlock R, Devereaux PJ; PVC-RAM Investigators. Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial. CMAJ Open. 2021 Mar 2;9(1):E142-E148. doi: 10.9778/cmajo.20200176. Print 2021 Jan-Mar.
PubMed 33653769
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) Trial
- ClinicalTrials.gov ID
- NCT04344665
- Acronym / sponsor ID
- PVC-RAM / v5.0, 2020.09.12
- Conditions
- Surgery, Perioperative Complication, COVID
- Keywords
- Virtual care, Remote monitoring, Days alive at home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 905 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, McMaster University
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Post discharge after surgery Virtual Care with Remote Automated Monitoring technology (PVC-RAM) 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 days alive at home during the 30-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. It will also determine, during the first 30 days, the effect of virtual care with RAM technology on several secondary outcomes, including: 1. hospital re-admission; 2. emergency department visit; 3. urgent-care centre visit; 4. acute-hospital care (i.e., a composite of hospital re-admission and emergency department or urgent-care centre visit) 5. brief acute-hospital care (i.e., acute-hospital care that lasts <24 hours); 6. all-cause hospital days; 7. medication error detection; 8. medication error correction; and 9. death. An additional secondary objective is to determine the effect of virtual care with RAM technology on pain at 7, 15, and 30 days and 6 months after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Care and Remote Automated Monitoring | Experimental | Other: Virtual Care and Remote Automated Monitoring |
| Standard Care | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- are ≥40 years of age;
- have undergone same-day or inpatient semi-urgent, urgent, or emergency surgery and are being discharged home or are within 24 hours after discharge home, as long as they have not had acute-hospital care since their discharge; and
- provide informed consent to participate.
Key exclusion criteria (4 listed)
- underwent same-day surgery and the surgeon or anesthesiologist believe the case reflects a traditional same-day surgery case with a low likelihood of needing acute-hospital care;
- went to rehabilitation or convalescent care for more than 7 days after undergoing surgery;
- are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to a cognitive, language, visual, or hearing impairment; or
- reside in an area without cellular network coverage and no home Wi-Fi.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Care and Remote Automated MonitoringPatients will measure daily vitals (blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, weight) with remote monitoring technology and complete recovery surveys daily in home after discharge from hospital. Patients will interact with a virtual nurse daily on days 1-15 and every other day from days 16-30. 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. Physicians will add or modify treatments as needed, and if required, they will have the patient come to an outpatient facility for evaluation or management. Via secure video or text messaging, patients will also have access to a virtual nurse at night, for any urgent issues. | Other | Virtual Care and Remote Automated Monitoring |
Primary outcome
Days alive at home
Time frame: 30 Days (after randomization); 6 months (after randomization)
Days alive at home are the number of days patients spend at their usual residence - be it a house or apartment, a group home or shelter, a seniors residence, or a nursing home - or at a community residence of a relative, friend, or acquaintance without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Thus, patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.
10 secondary outcomes
Hospital re-admission
Time frame: 30 Days (after randomization); 6 months (after randomization)
Emergency Department visit
Time frame: 30 Days (after randomization); 6 months (after randomization)
Urgent Care centre visit
Time frame: 30 Days (after randomization); 6 months (after randomization)
Brief acute hospital care
Time frame: 30 Days (after randomization); 6 months (after randomization)
Medication error detection
Time frame: Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Medication error correction
Time frame: Days 1, 7, 8, 15, 22 and 30 Days (after randomization in the intervention arm), 30 Days (after randomization in the standard care arm and collected on day 31)
Death
Time frame: 30 Days (after randomization); 6 months (after randomization)
Participant Pain
Time frame: 7 Days (after randomization); 15 Days (after randomization); 30 Days (after randomization); 6 months (after randomization)
Acute hospital care
Time frame: 30 Days (after randomization); 6 months (after randomization)
All-cause hospital days
Time frame: 30 Days (after randomization); 6 months (after randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 34593374McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Ouellette C, Bird M, Ofori S, Roshanov PS, Patel A, Yang H, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Conen D, Harvey V, Lounsbury J, Mian R, Bangdiwala SI, Arellano R, Scott T, Guyatt GH, Gao P, Graham M, Nenshi R, Forster AJ, Nagappa M, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Harlock J, Meyer RM, Taylor DA, Shanthanna H, Schlachta CM, Parry N, Pichora DR, Yousuf H, Peter E, Lamy A, Petch J, Moloo H, Sehmbi H, Waggott M, Shelley J, Belley-Cote EP, Devereaux PJ; PVC-RAM-1 Investigators. Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial. BMJ. 2021 Sep 30;374:n2209. doi: 10.1136/bmj.n2209.
- Derived from this study: PubMed 33653769McGillion MH, Parlow J, Borges FK, Marcucci M, Jacka M, Adili A, Lalu MM, Yang H, Patel A, O'Leary S, Tandon V, Hamilton GM, Mrkobrada M, Ouellette C, Bird M, Ofori S, Conen D, Roshanov PS, Harvey V, Guyatt GH, Le Manach Y, Bangdiwala SI, Arellano R, Scott T, Lounsbury J, Taylor DA, Nenshi R, Forster AJ, Nagappa M, Lamy A, Peter E, Levesque K, Marosi K, Chaudhry S, Haider S, Deuchar L, LeBlanc B, McCartney CJL, Schemitsch EH, Vincent J, Pettit SM, Paul J, DuMerton D, Paulin AD, Simunovic M, Williams DC, Halman S, Schlachta CM, Shelley J, Harlock J, Meyer RM, Graham M, Shanthanna H, Parry N, Pichora DR, Yousef H, Moloo H, Sehmbi H, Waggott M, Belley-Cote EP, Whitlock R, Devereaux PJ; PVC-RAM Investigators. Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM): protocol for a randomized controlled trial. CMAJ Open. 2021 Mar 2;9(1):E142-E148. doi: 10.9778/cmajo.20200176. Print 2021 Jan-Mar.
- Individual participant dataSharing planned: Yes. The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritises access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee. Data are available to the journal for evaluation of reported analyses. Regarding the ICES data, while data sharing agreements prohibit ICES from making the data set publicly available, access can be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael McGillion, PhD principal investigator
McMaster University, Population Health Research Institute
PJ Devereaux, PhD principal investigator
McMaster University, Population Health Research Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Care and Remote Automated Monitoring in people with Surgery and Perioperative Complication, run by Population Health Research Institute at 7 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 4 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: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Days alive at home (time frame: 30 Days (after randomization); 6 months (after randomization)). 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 NCT04344665, which also lists 2 linked publications.
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 6 Feb 2024.