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

December 4, 2024 updated by: Marnie Wilson, University of British Columbia

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 Overview

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days alive and out of hospital in the year following hospital discharge
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Emergency department visits and hospital admissions in the year following ICU admission
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • H24-03124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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