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Post Intensive Care Syndrome (PICS)CCRPNCT06723860

The Critical Care Recovery Program: Use of a Structured Clinic Visit to Reduce Adverse Drug Events in ICU Survivors

An observational study of Post Intensive Care Syndrome (PICS) and Polypharmacy, run by University of British Columbia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background and Objective: Intensive Care Units (ICUs) save lives, but many ICU survivors face ongoing health issues, including adverse drug events (ADEs) from medications started during their hospital stay. These ADEs lead to emergency department visits and hospital admissions. Read more about this study

Who is it for?
Ages 18 years and older
How many people
3,000 participants
Where
No sites listed yet
Study dates
30 Jan 2025to 30 Dec 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients meeting inclusion / exclusion criteria above (per FICM guidelines for critical care recovery program follow up)

Who may be able to join

  • Patient being discharged to ward, home or repatriated to local health centre AND ONE OR MORE OF
  • Duration of mechanical ventilation >72 hours
  • Length of stay in critical care >96 hours
  • Out of hospital arrest
  • Maternal critical illness
  • Trauma
  • Significant ICU delirium
  • Unexpected adverse outcomes of planned treatment

Who cannot join

  • Patient discharged for palliative care or expected to die within the next two months

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Marnie A Goodwin Wilson, MD, MSc, MPH contact

6047907627

marnie.gwilson@gmail.com

About this study

Background and Objective: Intensive Care Units (ICUs) save lives, but many ICU survivors face ongoing health issues, including adverse drug events (ADEs) from medications started during their hospital stay. These ADEs lead to emergency department visits and hospital admissions. Our project aims to improve the health of ICU survivors by creating a clinic that focuses on managing post-ICU health. The clinic will track and address medical issues that arise after ICU discharge and focus on deprescribing, or safely stopping, medications that may no longer be needed or could be harmful.

Project Plan: The clinic will be set up within the CARES clinic at VGH. Patients will be enrolled when they leave the ICU and will have follow up visits after hospital discharge. During these visits, the team will review each patient's medications and develop a personalized plan to reduce or stop unnecessary medications. We will also monitor patients for any new health issues that arise and provide eduction to patients and caregivers about managing their health.

Read more

Research and Evaluation: We will collect and analyze data on patient health outcomes, including the incidence of ADEs, hospital reeadmissions, and emergency department visits. We hope to show that patients who receive follow up care have better health outcomes and use fewer healthcare resources than a historical cohort. This data will help us demonstrate the cost-effectiveness of the clinic and support the need for expanding ICU follow up programs in British Columbia.

Long-term goals: We plan to establish a post-ICU care working group and expand the clinic model to other hospitals. Over the long term, we hope to standardize post-ICU care across BC, ensuring that all ICU survivors have access to comprehensive follow up care. This project will also lay the groundwork for future research on deprescribing medications for ICU related complications, which tend to improve or resolve once critical illness has resolved. The CCRP clinic will provide a setting to conduct clinical deprescription trials to establish whether long-term treatment of these complications is necessary.

Conclusion: Establishing a post-ICU discharge follow up clinic with a focus on deprescription has the potential to improve the long-term health and quality of life for ICU survivors. By reducing unnecessary medications, we can prevent complications, reduce hospital readmissions and demonstrate the value of comprehensive post-ICU follow up care.

Medical subject headings
postintensive care syndrome, Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06723860
Study groupRoleWhat they receive
Retrospective control cohortRetrospectively collected data on a group of intensive care survivors who were not referred for a post-ICU clinic visit.
Intervention cohortPatients meeting FICM criteria who are referred for a CCRP clinic visit and consent to participation in research

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days alive and out of hospital in the year following hospital discharge

    Measured: 1 year

Secondary outcomes (1)
  1. Emergency department visits and hospital admissions in the year following ICU admission

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2024
  2. Study start30 Jan 2025 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
3,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06723860
Sponsor's protocol ID
H24-03124
Acronym
CCRP
Status last verified
Dec 2024
First submitted
4 Dec 2024
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be retained in a database for as long as the clinic is active. Other researchers with REB approval may request access to the data, which will be long term ICU follow up data and potentially applicable to many other studies. This data can be released at the discretion of the principal investigator.

Questions about this trial

What is this clinical trial studying?

An observational study of Post Intensive Care Syndrome (PICS) and Polypharmacy, run by University of British Columbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marnie A Goodwin Wilson, MD, MSc, MPH (6047907627, marnie.gwilson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days alive and out of hospital in the year following hospital discharge (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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