Evaluating follow-up care for ICU survivors and their caregivers
Improving Medical and Psychological Outcomes After Discharge - Feasibility Study for a Pragmatic, Mixed-methods, Open-label Randomized Controlled Trial Examining the Effectiveness of a Follow-up Clinic for ICU Survivors and Caregivers
This study tests whether special follow-up care can help ICU survivors and their caregivers recover better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT06681649 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult ICU survivors at high risk for long-term complications and their informal caregivers.
Not a fit: Patients who do not have access to a primary care physician or those with a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the long-term outcomes and quality of life for ICU survivors and their caregivers.
How similar studies have performed: Other studies have indicated that follow-up care can improve outcomes for ICU survivors, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kingston, Ontario
- Queen's University — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: J G Boyd, MD PhD
- Email: gordon.boyd@kingstonhsc.ca
- Phone: 6135496666 x6228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.