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

Pontificia Universidad Catolica de Chile

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05827354

Fondecyt Iniciacion 11230203

11230203 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 175 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All adult family members (≥ 18 years old) identified as the patient´s representative, Spanish speakers, and likely to become responsible for providing and/or coordinating patient care after hospital discharge will be eligible.

Besides, the patient must have between 48 hours and 10 days in the ICU, be > 18 years old, and receive respiratory support (noninvasive ventilation, high-flow nasal cannula, or invasive mechanical ventilation).

Exclusion criteria

Family members of ICU patients with a high impending death risk (including end-of-life care / only comfort measures) or likely to be discharged from the ICU in the following 24 hours will be excluded.

Subjects (family members) will be withdrawn from the study at any point if the patient dies.

Trial design

175 participants in 1 patient group

Family Members

Description:

Family members of patients admitted to the ICU between the 1st of May 2025 and the 30th of May 2023, who survived ICU stay and are still alive up to 6 months after hospital discharge.