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Virtual Care + RAM for Post-Surgery Recovery (PVC-RAM-3 Trial)
N/A
Recruiting
Led By Michael McGillion, PhD
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients are undergoing inpatient elective noncardiac surgery with an expected length of hospital stay ≤3 days after surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 and 30 days post randomization
Awards & highlights
PVC-RAM-3 Trial Summary
This trial is testing whether or not virtual care with remote automated monitoring is more effective than standard care in reducing length of stay in the hospital for adults who have undergone elective non cardiac surgery, as well as reducing the risk of acute hospital care, re-admission, emergency department visits, and surgical site infections.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves virtual monitoring rather than medication or invasive procedures, side effects are minimal but may include privacy concerns or technical difficulties with the RAM technology.
PVC-RAM-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a planned surgery that is not heart-related and I should be in the hospital for 3 days or less afterwards.
PVC-RAM-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 and 30 days post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 and 30 days post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Index hospital length of stay
Secondary outcome measures
Acute hospital care (composite of hospital readmission and emergency department visit)
Days in hospital
Emergency department visit (includes urgent care centre visit)
+6 moreOther outcome measures
Death
Health related quality of life (HRQoL)
Health services utilization-related costs
+3 morePVC-RAM-3 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Care with Remote Automated MonitoringExperimental Treatment1 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 CareActive Control1 Intervention
Standard post surgical care per treating institution.
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Who is running the clinical trial?
Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
677,412 Total Patients Enrolled
4 Trials studying Surgery
3,025 Patients Enrolled for Surgery
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
298,493 Total Patients Enrolled
5 Trials studying Surgery
1,448 Patients Enrolled for Surgery
Michael McGillion, PhDPrincipal InvestigatorMcMaster University, Population Health Research Institute
3 Previous Clinical Trials
2,940 Total Patients Enrolled
2 Trials studying Surgery
2,905 Patients Enrolled for Surgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Care with Remote Automated Monitoring
- Group 2: Standard Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been enrolled in this clinical experimentation?
"Affirmative. According to the info available on clinicaltrials.gov, this experimentation is still open for participants and was first posted in December of 2021. At present, it requires 2500 volunteers from 2 research centres."
Answered by AI
Is this experiment presently open to new participants?
"Affirmative. The information available on clinicaltrials.gov reveals that this research is actively searching for 2500 participants at 2 medical centres. This effort was first posted on December 28th 2021, with the last edits being made on October 12 2022."
Answered by AI
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