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

\~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.

NCT Number	NCT06681649
Lead Sponsor	Queen's University
Conditions	Critical Illness, Delirium in the Intensive Care Unit
Enrollment	40 participants
Start Date	2024-06-01
Primary Completion	2025-06-01 (estimated)
Study Completion	2025-06-01 (estimated)
Updated on ClinicalTrials.gov	2024-12-04