Incidence and Factors Associated to the Development of PICS-F Among ICU Relatives: A Longitudinal Exploratory Study

Critical Illness Clinical Trial

Official title: Incidence and Factors Associated to The Development of Post-Intensive Care Syndrome Among Family Members of Intensive Care Unit Survivors: A Longitudinal Exploratory Study

Status Recruiting

Clinical Trial Summary

The constellation of long-term psychological, physical, and cognitive impairments arising after a critical illness among family members of ICU survivors has been labeled as "Post Intensive Care Syndrome - Family" (PICS-F). Despite PICS-F awareness, the long-term issues faced by ICU family members remain poorly understood with several gaps in knowledge remaining such as the role of protective psychosocial factors, caregiver burden, or family satisfaction in the development of the syndrome.

This single-center, longitudinal exploratory study, aims to determine the incidence of each PICS-F impairment (psychological, physical, and cognitive) and to identify factors (during ICU stay and after hospital discharge) associated with the development or prevention of the PICS-F impairments among family members of ICU survivors of a public hospital in Chile.

Clinical Trial Description

During the last decades, intensive care unit (ICU) mortality rates have significantly decreased but not without adverse health-related consequences for patients and their family members. Admission to an ICU is often a stressful and traumatic experience for family members, leading to adverse psychosocial outcomes lasting beyond 12 months after hospital discharge.

The constellation of long-term psychological, physical, and cognitive impairments arising after a critical illness among family members of ICU survivors, has been labeled as "Post Intensive Care Syndrome - Family" (PICS-F). PICS-F is now being recognized as a public health burden with substantial associated costs. Despite PICS-F awareness, the long-term issues faced by ICU family members remain poorly understood with several gaps in knowledge remaining unanswered.

First, PICS-F evidence (incidence and related factors) is focused predominantly on psychological impairments with few studies exploring physical and cognitive impairments. Equally, studies on the influence of psychosocial resources (e.g., resilience, social support), which could offset PICS-F-related stress, are limited. Second, while up to 80% of the ICU family members become caregivers after the patient's hospital discharge, the effect of caregiver burden on PICS-F has received little attention. Third, is not clear the extent to which the family member´s evaluation of the ICU experience, known as family satisfaction, or other variables measured in this period can influence PICS-F.

The aim of this study is two-fold, one cross-sectional and one longitudinal aim. Among family members of ICU survivors of a public hospital in Chile, this study aims:

1. To determine the incidence of each PICS-F impairment (psychological, physical, and cognitive).

2. To identify factors associated with PICS-F impairments during ICU stay and after hospital discharge. ;

Related Conditions & MeSH terms

• Caregiver Burden
• Cognitive Impairment
• Critical Illness
• Family Members
• Family Satisfaction
• Mental Health
• Physical Health
• Post Intensive Care Syndrome
• Resilience
• Social Support
• Syndrome

• NCT number: NCT05827354
• Study type: Observational
• Source: Pontificia Universidad Catolica de Chile
• Contact: Cristobal Padilla F., PhD
• Phone: +56964587104
• Email: cfpadill@uc.cl
• Status: Recruiting
• Start date: June 27, 2023
• Completion date: November 2025