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Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers

Critical Illness | Delirium in the Intensive Care Unit

\~80% of ICU survivors experience profound long-term cognitive, physical, and psychiatric impairments known as post-intensive care syndrome (PICS). Caregivers additionally experience similar detrimental psychosocial effects following discharge. Despite this knowledge, follow-up care is almost non-existent. ICU follow-up clinics may mitigate these long-term impacts, but lack evaluation of their effectiveness. This trial will evaluate the effectiveness of ICU follow-up clinics vs. standard-of-care in improving qualitative/clinical outcomes of ICU survivors and caregivers, with those receiving follow-up care hypothesized to have improved outcomes.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

Queen's University
Queen's University
Kingston, Ontario
Canada

Contact Study Team

Backup Contact

J G Boyd, MD PhD FRCPC

Primary Contact

Gordon Boyd, MD PhD FRCPC

[email protected]
6135392754
Study Sponsored By
Queen's University
Participants Required
More Information
Study ID: NCT06681649