Evaluating follow-up care for ICU survivors and their caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial assesses the effectiveness of specialized follow-up care for ICU survivors and their caregivers compared to standard care. Approximately 80% of ICU survivors face long-term cognitive, physical, and psychiatric challenges, while caregivers also suffer psychosocial effects. The intervention includes follow-up appointments, informational resources, and journaling tools to support recovery. The study employs a pragmatic, mixed-methods approach, utilizing both quantitative clinical assessments and qualitative focus groups to gather comprehensive insights on recovery experiences.

Why it matters

Who can join: the full rules

Inclusion criteria - ICU survivors

1. Adult patients (age greater than or equal to 18 years)
2. Life expectancy greater than or equal to 6 months as determined by the attending physician
3. High risk for long-term functional sequelae following ICU discharge, defined as ICU stay greater than or equal to 4 days, or involving at least one of:

   * mechanical ventilation (any, i.e., invasive or non-invasive)
   * tracheostomy
   * delirium (defined as Confusion Assessment Method (CAM) positive or documented history of delirium in the patient's medical record by the clinical care team at some point during their ICU admission)
   * lack of access to a primary care physician for clinical follow-up
   * access to email or mail to complete follow-up questionnaires
   * presence of an informal caregiver

Inclusion criteria - Caregivers

1. Informal caregiver (e.g., spouse, offspring) for ICU survivor as defined above
2. Adult (age greater than or equal to 18 years)

Exclusion criteria - ICU survivors and caregivers

* Neurological or communication difficulties which would preclude completion of follow-up assessments or participation in focus groups
* Inability to speak or read English (required for completion of standardized questionnaires, clinical assessments, and for participation in focus groups)
* Failure to provide consent/failure to have consent provided by a substitute decision maker

Where it's running

• Queen's University
  Kingston, Ontario, Canada Recruiting

Study contacts

• Study coordinator: J G Boyd, MD PhD
• Email: gordon.boyd@kingstonhsc.ca
• Phone: 6135496666 x6228

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.