Feasibility Study of a Follow-Up Care Program for ICU Survivors and Their Caregivers to Improve Medical and Psychological Recovery

What this Trial Is About

Approximately 80% of patients who survive intensive care units ICU experience lasting cognitive, physical, and mental health challenges known as post-intensive care syndrome PICS. Caregivers of these patients also face harmful psychosocial effects after discharge. Despite this, follow-up care is rarely provided. This trial aims to evaluate the effectiveness of specialized ICU follow-up clinics compared to standard care in improving the health and well-being of ICU survivors and their caregivers. Participants in the intervention group will attend specialized follow-up clinics at about 1 and 3 months after ICU discharge. They will also receive information materials explaining what to expect after ICU discharge and diaries to record experiences during recovery, which healthcare teams, family, and patients can use. The control group will receive usual care from their primary care providers, which can vary widely. Both ICU survivors and their caregivers are invited to participate in the follow-up clinics. During the study, participants will undergo clinical assessments measuring brain function, quality of life, anxiety, depression, post-traumatic stress, resilience, pain, fatigue, physical strength, medication use, and hospital readmissions. Caregivers will also have their burden and sleep quality assessed. Researchers will use focus groups to understand patient priorities and assess data capture, consent, enrollment, follow-up rates, and safety over six months. This study will help identify effective follow-up care to reduce long-term impacts of PICS for patients and caregivers.

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