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.
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
- Conditions the study is for
- Post Intensive Care Syndrome (PICS), Polypharmacy, Adverse Drug Events
- 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.
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.
- Conditions
- Post Intensive Care Syndrome (PICS), Polypharmacy, Adverse Drug Events, Critical Care, Intensive 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 group | Role | What they receive |
|---|---|---|
| Retrospective control cohort | Retrospectively collected data on a group of intensive care survivors who were not referred for a post-ICU clinic visit. | |
| Intervention cohort | Patients 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.
Days alive and out of hospital in the year following hospital discharge
Measured: 1 year
Secondary outcomes (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.
- First posted9 Dec 2024
- Study start30 Jan 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care Syndrome (PICS)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marnie Wilson, University of British Columbia
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Critical Care Recovery Program: Use of a Structured Clinic Visit to Reduce Adverse Drug Events in ICU Survivors
- ClinicalTrials.gov ID
- NCT06723860
- Acronym / sponsor ID
- CCRP / H24-03124
- Conditions
- Post Intensive Care Syndrome (PICS), Polypharmacy, Adverse Drug Events, Critical Care, Intensive Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective control cohort | – | –Retrospectively collected data on a group of intensive care survivors who were not referred for a post-ICU clinic visit. |
| Intervention cohort | – | –Patients meeting FICM criteria who are referred for a CCRP clinic visit and consent to participation in research |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting inclusion / exclusion criteria above (per FICM guidelines for critical care recovery program follow up)
Key inclusion criteria (8 listed)
- Patient being discharged to ward, home or repatriated to local health centre AND ONE OR MORE OF
Key exclusion criteria (1 listed)
- Patient discharged for palliative care or expected to die within the next two months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Days alive and out of hospital in the year following hospital discharge
Time frame: 1 year
1 secondary outcome
Emergency department visits and hospital admissions in the year following ICU admission
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: 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.
Related trials for Post Intensive Care Syndrome (PICS)
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
Not yet recruitingObservational study
PICS-p Longitudinal Cohort Study
Physical Functional Impairment, Cognitive Impairment
RecruitingObservational study
Post-ICU Syndrome and Social Determinants of Healths
Post-Intensive Care Syndrome (PICS)
RecruitingObservational study
Post Intensive Care Accelerometery to Study and Support Recovery Outcomes
Post Intensive Care Syndrome (PICS)
RecruitingObservational study
Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
PICS, PICS-F
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.