Active not recruitingNAINTERVENTIONAL

Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology-3 Trial

This study, called PVC-RAM-3, is for adults having planned surgery that isn't on the heart. It's designed to see if a special virtual care program, which uses smart monitoring devices at home, works better than typical care after you leave the hospital. We want to find out if this virtual care can help you spend less time in the hospital initially and reduce your chances of needing to return to the hospital or emergency room later. Researchers will also check things like how well pain is managed, if anyone has problems with their medicines, and if there are any infections. The study aims to improve how we look after people after surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Population Health Research Institute

Enrolment target

2,500

Start

28 Dec 2021

Estimated completion

31 May 2025

Surgery

What is this study about?

Imagine you've just had surgery and are back home. This study is looking at a new way to help you recover called 'virtual care with remote automated monitoring' (let's call it 'smart monitoring'). This means you might use special devices at home that can automatically check your health, and a healthcare team can keep an eye on you without you needing to go back to the hospital. We want to see if this smart monitoring system helps you get better faster and avoids problems that might send you back to the hospital.

Specifically, the study aims to understand if this smart monitoring approach means you spend less time in the hospital right after your surgery. It also wants to check if it lowers your chances of being readmitted to the hospital or needing to go to the emergency room in the first month after your surgery. Think of it as having a bit of extra support and watchful eyes on your recovery from the comfort of your own home.

Besides these main goals, the study will also look at how well your pain is managed, if you have any problems with your medicines, or if you get any infections. For people with certain long-term health conditions or those who smoke, the study will also check if they are taking the right medications to manage their health well after surgery. All of this information helps us understand if this new way of caring for people after surgery is better than what's usually done.

Key takeaways

This study explores a new way to care for people after non-heart surgery.
It tests 'smart monitoring' at home versus usual hospital care.
Aims to see if it shortens hospital stays and prevents re-admissions/ER visits.
Participation lasts for 30 days after hospital discharge.
No new medications are involved in the study.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. You should be having a planned (not emergency) operation that isn't on your heart, and your doctors expect you to be in the hospital for three days or less after your surgery. Lastly, you need to be able to understand what the study involves and agree to participate.

However, there are a few reasons why you might not be able to join. If you have trouble communicating with the study team, filling out surveys, or using a tablet computer because of language difficulties, or problems with your memory, sight, or hearing, then this study might not be suitable for you. Also, if you live in an area where your mobile phone doesn't get a signal, you wouldn't be able to participate because the monitoring devices need network coverage to work.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having planned surgery (not heart surgery) and expect to stay in hospital for 3 days or less?
Are you able to speak with staff and understand information in English, or another language they support, without difficulty?
Do you have mobile phone signal/network coverage where you live?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups: either you'll receive the 'smart monitoring' virtual care or you'll receive the usual care you would expect after surgery. The type of care you receive will last for 30 days after you are discharged from the hospital. During this time, the study team will be checking in on your health outcomes.

For those in the smart monitoring group, you would use special devices at home to send your health information to the team. Everyone in the study will have some assessments, which might include answering questions about your pain levels and any medicine issues, usually at 15 and 30 days after your surgery. You won't be asked to take any new or different medications specifically for the study. The total duration of your active involvement in the study's follow-up will be 30 days after you leave the hospital.

Potential risks and benefits

People taking part in this study might experience potential benefits, such as receiving closer monitoring after surgery through the smart monitoring system, which could lead to earlier detection of potential issues. This might help reduce the chance of returning to the hospital or needing emergency care. However, there's also a possibility that the smart monitoring system doesn't make a big difference, and you might still experience issues common after surgery. While the risks are generally low, using new technology always comes with small potential challenges, like technical glitches. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

Hamilton General Hospital
Verified postcode
Hamilton, Canada
Juravinski Hospital
Verified postcode
Hamilton, Canada

Common questions

What kind of surgery is this study for?

This study is for adults having planned surgery that is not on the heart. It's for common surgeries where you’re expected to stay in hospital for three days or less.

What does 'virtual care with remote automated monitoring' mean?

It means using smart devices at home to automatically check your health after surgery. A healthcare team can then look at this information without you needing to visit the clinic in person.

How long does the study last if I take part?

If you join, the study will follow your progress for 30 days after you leave the hospital.

Will I have to take new medicines for this study?

No, you will not be asked to take any new or different medications as part of this study.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time without it affecting your medical care.