IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers.

Introduction: Survivors of critical illness and their caregivers are at risk for long-term cognitive, physical and psychiatric impairments known as post-intensive care syndrome (PICS) and PICS-family, respectively. This study will assess the feasibility of a randomised controlled trial (RCT) evaluating an intensive care unit (ICU) follow-up care bundle versus standard-of-care for ICU patients and their caregivers.

Methods And Analysis: This is a single-centre feasibility study. Survivors of critical illness will be eligible if: age ≥18 years, life expectancy ≥6 months and high risk for PICS. We define high risk as ICU stay ≥4 days or involving 1+ of mechanical ventilation, tracheostomy, delirium or lack of access to a primary care physician (PCP). 20 ICU survivor-primary caregiver dyads will be enrolled (n=10 dyads per group) and randomised 1:1 to the intervention versus control group. The intervention will be: (1) diaries to journal patient experiences, (2) information packages on expectations post-discharge and (3) specialised follow-up care at 1 and 3 months post-discharge. The control group will receive standard of care in the ICU and follow-up with their PCP. The primary outcome is feasibility, defined as: (1) consent rate >80%, (2) enrolment rate of 4 participants/month, (3) follow-up rate>70% and (4) data capture rate >80%. Our secondary objective is to explore the perspectives of survivors of critical illness and their families about the intervention and their participation in the study. Tertiary outcomes will be a battery of cognitive, physical functioning and psychiatric outcomes.

Implications: Survivorship from critical illness extends beyond surviving an ICU stay. This project will lay the foundation for performing a large, multicentre pragmatic RCT with survivors of critical illness and their caregivers, paving the way for improved long-term healthcare.

Ethics And Dissemination: This study has received approval (6039808) from the Queen's University Health Sciences/Affiliated Teaching Hospitals Research Ethics Board. Results will be presented at critical care conferences. A lay summary co-designed with ICU survivor participants will be provided to patients.

Trial Registration Number: NCT06681649.