Virtual Care for Post-Intensive Care Syndrome

(VPICS Trial)

Not yet recruiting at 1 trial location

Overseen By Julia Hajjar, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hopital Montfort

Disqualifiers: Assisted living, End-stage illnesses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an online clinic can aid individuals recovering from an ICU stay in regaining strength and abilities. Participants will engage in a year-long virtual program that offers support with physical therapy, nutrition plans, mental health, and brain exercises. The researchers aim to determine if this online support, provided by the VPICS Clinic, improves daily functioning. Individuals who spent at least two days on a ventilator in the ICU and were discharged from the hospital within the last two months may be suitable for this study. As an unphased trial, this study provides a unique opportunity to access innovative online support that could significantly enhance recovery.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual clinic is safe for patients with post-intensive care syndrome?

Research has shown that virtual clinics for post-intensive care syndrome (PICS) are generally safe for patients. One study found these online rehabilitation services to be both safe and effective. These clinics provide online support, including physical therapy, mental health assistance, and exercises to enhance cognitive skills.

The available research does not report any serious side effects from these digital health programs. Participants in these programs have not experienced significant negative effects, suggesting that virtual care is well-tolerated by most people.

Joining this type of clinic offers a safe way to regain strength and mental well-being after intensive care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VPICS Clinic because it offers a novel approach to managing Post-Intensive Care Syndrome (PICS) through virtual care. Unlike traditional in-person follow-up care, which can be difficult for patients to access due to mobility issues or geographic barriers, the VPICS Clinic allows patients to receive care from the comfort of their homes. This method not only increases accessibility but also provides a more personalized and continuous support system for recovery. The integration of virtual care aims to improve patient outcomes by ensuring timely interventions and reducing the burden on healthcare facilities.

What evidence suggests that this virtual clinic is effective for post-intensive care syndrome?

Studies have shown that virtual care can aid recovery from post-intensive care syndrome (PICS). Online healthcare services, such as virtual clinics and telehealth, have been linked to improved recovery outcomes for PICS patients. These services assist with physical therapy, nutrition, mental health, and cognitive support. Research indicates that clinics for post-ICU patients can support long-term recovery by addressing various needs of those who have been in intensive care. This trial will evaluate the VPICS Clinic, which provides a wide range of services, to determine its effectiveness in helping patients regain abilities after intensive care. ^{1 3 6 7 8}

Who Is on the Research Team?

Kwadwo Kyeremanteng, MD

Principal Investigator

Hôpital Montfort

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were on a ventilator in the ICU for at least 48 hours and left the hospital within the last two months. It's not suitable for those with terminal illnesses, high fall risk, inability to consent, lack of digital skills or support, or if they can't communicate in English or French.

Inclusion Criteria

I am over 18 years old.

I was on a breathing machine in the ICU for at least 2 days.

I was discharged from the hospital within the last 2 months.

Exclusion Criteria

Do not have the technological skills or caregiver support to ensure digital literacy

Individuals originating from an assisted living/long-term care facility

I am unable to understand and make decisions about my medical care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants participate in a 12-month online clinic receiving physiotherapy, nutritional planning, mental health support, and cognitive strengthening

12 months

Virtual sessions throughout the 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VPICS Clinic

Trial Overview The study tests a virtual clinic program (VPICS Clinic) designed to help patients recovering from intensive care improve their physical function. Over 12 months online, participants get physiotherapy, nutrition plans, mental health support and brain exercises while tracking their progress.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Clinic participation

Who Is Running the Clinical Trial?

Hopital Montfort

Lead Sponsor

Trials

15

Recruited

5,000+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05597007

Virtual Care to Improve Post-Intensive Care Syndrome Referred patients will access live sessions with healthcare professionals who will guide at-home strategies to address PICS including physiotherapy, nutritional ...

2. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-05089-6

Exploring the effectiveness of eHealth interventions in treating ... Our review aimed to evaluate the effectiveness of eHealth interventions on PICS outcomes. Methods. Studies reporting eHealth interventions ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12502439/

Post-intensive care unit clinics: models and implementation Exploring the effectiveness of eHealth interventions in treating Post Intensive Care Syndrome (PICS) outcomes: a systematic review. Crit Care.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10785368/

Post-intensive care syndrome follow-up system after hospital ... A PICS follow-up clinic was proposed as an approach to evaluate ICU survivors and their families' long-term outcomes [15]. In 2006, PICS follow- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949788423000369

Post-ICU Clinic Post-ICU clinics are one way to help patients with PICS and to assist patients in their recovery progress. We report herein how we have structured our ICU ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8443843/

Virtual Reality to Improve Sequelae of the Postintensive Care ... The aim of this study was to explore patient-related determinants of ICU-specific virtual reality, such as the timing of patients' self-reported ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949761224001159

Review Digital Health Interventions Supporting Recovery ... This scoping review provides a comprehensive overview of digital health interventions designed to support the recovery of ICU patients and their family members.

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1513121/full

Transitioning to a virtual post-intensive care rehabilitation ... This study aimed to describe the key components of a safe and effective virtual post-intensive-care rehabilitation service, through qualitative exploration.