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Virtual Care + RAM for Post-Surgery Recovery (PVC-RAM-3 Trial)

Hamilton, Canada

N/A

Recruiting

Led By PJ Devereaux, 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

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

No Placebo-Only Group

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.

See full description

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.

Eligibility Criteria

Inclusion Criteria

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

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I am having a planned surgery that is not heart-related and I should be in the hospital for 3 days or less afterwards.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 and 30 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

Index hospital length of stay

Secondary study objectives

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

Days in hospital

Emergency department visit (includes urgent care centre visit)

+6 more

Other study objectives

Death

Health related quality of life (HRQoL)

Health services utilization-related costs

+3 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-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.

0 / 1Eligibility criteria met