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

Hamilton, Canada

N/A

Recruiting

Led By Sandra Ofori, M.D., 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

Must not have

are unable to communicate with research staff, complete study surveys, or undertake an interview using a tablet computer due to cognitive, visual, or hearing impairment; or

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 and 45 days post randomization

Awards & highlights

No Placebo-Only Group

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.

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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.

Eligibility Criteria

Inclusion Criteria

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

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I am 40 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can communicate and use a tablet for surveys or interviews despite any impairments.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 and 45 days post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 and 45 days post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 and 45 days post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute-hospital care

Secondary study objectives

Days in hospital

Emergency department visit

Hospital readmission

+8 more

Other study objectives

Acute Heart Failure

Arrhythmia that results in patient presenting to an emergency department or being admitted to hospital

Death

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 and complete a daily recovery survey for 14 days after index hospital discharge, and nurses will review these results daily. Through scheduled video visits, patients will virtually interact with a nurse on days 1, 3, 7 and 14, and a physician on days 1 and 14. Patients will take a photograph of their wound daily for the first 7 days on the program, and nurses will review these pictures. 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, they will escalate care to a pre-assigned and available physician. Two 7-day extensions to the intervention will be possible, based on the patient's need for continued support. This decision will be based on standardized criteria.

Group II: Standard CareActive Control1 Intervention

Patients randomized to standard care will receive post discharge care as per the standard of care at the hospital where they undergo surgery.

0 / 2Eligibility criteria met