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Virtual Care + RAM for Post-Surgery Complications (PVC-RAM-2 Trial)

N/A

Waitlist Available

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

are ≥40 years of age;

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post randomization

Awards & highlights

PVC-RAM-2 Trial Summary

This trial is testing whether or not virtual care with remote automated monitoring (RAM) technology is more effective than standard care in reducing hospital readmissions, emergency department visits, and surgical site infections, as well as medication errors.

Who is the study for?

This trial is for adults over 40 who've had semi-urgent, urgent, or emergency surgery and are being discharged. They must be able to use a tablet computer for communication and surveys without cognitive, visual, or hearing issues. Those in rehab more than 7 days post-surgery or living without cell coverage can't join.Check my eligibility

What is being tested?

The PVC-RAM-2 Trial tests if virtual care with remote automated monitoring tech is better than standard care after surgery. It looks at hospital visits within 30 days of discharge and checks medication errors and surgical site infections. Pain levels will also be monitored up to a month later.See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring technology rather than medications, traditional side effects aren't expected. However, participants may experience privacy concerns or stress related to the use of technology for their health monitoring.

PVC-RAM-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 40 years old or older.

PVC-RAM-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute-hospital care

Secondary outcome measures

Emergency department visit

Hospital readmission

Medication error correction

+5 more

Other outcome measures

Communicable Diseases

Death

Health services utilization-related costs

+7 more

PVC-RAM-2 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Care with Remote Automated MonitoringExperimental Treatment1 Intervention

Patients randomized to the PVC-RAM-2 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 would photos during the 30 days after randomization. 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

677,912 Total Patients Enrolled

Michael McGillion, PhDPrincipal InvestigatorMcMaster University, Population Health Research Institute

3 Previous Clinical Trials

3,440 Total Patients Enrolled

PJ Devereaux, M.D, PhDPrincipal InvestigatorMcMaster University, Population Health Research Institute

1 Previous Clinical Trials

2,500 Total Patients Enrolled

Media Library

Complications Research Study Groups: Standard Care, Virtual Care with Remote Automated Monitoring

Complications Clinical Trial 2023: Virtual care with remote automated monitoring Highlights & Side Effects. Trial Name: NCT04876950 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for this trial?

"The clinicaltrials.gov website reveals that this particular trial, which was initially posted on January 1st 2023 and last revised on September 29th 2022, is not currently enlisting subjects. However, there are still 262 other trials actively recruiting candidates at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) -2 Trial

2024. "Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology (PVC-RAM) -2 Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04876950.