A Co-Designed Post-ICU Follow-Up Pathway Is Feasible and May Be Associated With Improved Psychosocial Recovery for Patients and Their Caregivers: Outcomes From the IMPACT-ICU Single-Center Randomized Controlled Trial.

Post-intensive care syndrome (PICS) and PICS-family (PICS-F) lead to lasting physical, cognitive, and psychologic challenges among survivors of critical illness and their caregivers. It is unclear how best to support these individuals. We aimed to evaluate the feasibility of a co-designed, multicomponent post-ICU follow-up intervention and to explore its association with symptoms of PICS and PICS-F. This was a pragmatic, mixed-methods randomized controlled trial. This study was conducted at an academic ICU in Canada. We enrolled 20 patient-caregiver dyads (n = 40 participants). Patients were eligible if they were 18 years old or older, expected to survive greater than or equal to 6 months after discharge from ICU, and were at high-risk for PICS. Caregiver participants were adult caregivers of enrolled patients. Dyads were randomized 1:1 to receive usual care or an intervention bundle co-designed with patients and caregivers, consisting of an ICU diary, informational materials, and two multidisciplinary follow-up clinic visits at 1 and 3 months after ICU discharge. Trial outcomes included feasibility metrics, qualitative interviews, process evaluation, and clinical measures at 6 months. Qualitative data were analyzed using reflexive thematic analysis. Quantitative outcomes included PICS symptomatology, quality of life, caregiver burden, healthcare utilization, and functional status. The consent rate was 87.5%, with a mean enrollment of 5.25 participants/month. Twenty dyads were randomized; one ICU participant in each group died before their 6-month follow-up. Seven of nine dyads in the intervention and all nine in the control completed 6-month follow-up. Intervention group survivors had lower depressive symptom scores compared with controls. Intervention group caregivers reported higher emotional well-being and social functioning scores and lower anxiety, depression, and caregiver burden. Qualitative findings demonstrated greater emotional support, preparedness, and continuity of care in the intervention group. Our post-ICU care bundle was feasible and may be associated with improved psychosocial outcomes.