An observational study in Post Intensive Care Syndrome, Family Members and Caregiver Burden, sponsored by Pontificia Universidad Catolica de Chile. Status unknown at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Pontificia Universidad Catolica de Chile · Observational
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.
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:
49 studies on the registry are indexed under postintensive care syndrome; 26 are open to participants now.
This study's planned enrollment of 175 is below the median of 200 across 23 observational studies indexed under postintensive care syndrome.
Browse postintensive care syndrome studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 222 studies on the registry; 57 are open to participants now.
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Family members of ICU survivors in a public hospital in Santiago, Chile who meet the inclusion criteria will be invited to the study.
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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.
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.
Incidence of psychological impairment in family members of ICU survivors
Symptoms of anxiety and depression (1) or Post-traumatic stress disorder (PTSD) (2) (1 or 2): 1. Anxiety and depressive symptoms measured using the 4-item version of the Patient Health Questionnaire (PHQ - 4), summed score range from 0 (best) to 12 (worst). Presence of symptoms of anxiety and depression if summed PHQ - 4 score ≥ 6. 2. PTSD symptoms measured using the 6-item version of the Impact of Event Scale (IES - 6), summed score range from 0 (best) to 24 (worst). Presence of PTSD symptoms if averaged IES - 6 score ≥ 1.75.
Time frame: 3 months after hospital discharge
Incidence of psychological impairment in family members of ICU survivors
Symptoms of anxiety and depression (1) or Post-traumatic stress disorder (PTSD) (2) (1 or 2): 1. Anxiety and depressive symptoms measured using the 4-item version of the Patient Health Questionnaire (PHQ - 4), summed score range from 0 (best) to 12 (worst). Presence of symptoms of anxiety and depression if summed PHQ - 4 score ≥ 6. 2. PTSD symptoms measured using the 6-item version of the Impact of Event Scale (IES - 6), summed score range from 0 (best) to 24 (worst). Presence of PTSD symptoms if averaged IES - 6 score ≥ 1.75.
Time frame: 6 months after hospital discharge
Incidence of physical impairment in family members of ICU survivors
Symptoms of clinically significant fatigue. Clinical fatigue measured using 4 items of the "energy/fatigue" subscale (Vt) of the Short Form Health Survey (SF - 36). Averaged score range from 100 (best) to 0 (worst): Presence of clinical fatigue if averaged SF - 36 Vt score \< 45.
Time frame: 3 months after hospital discharge
Incidence of physical impairment in family members of ICU survivors
Symptoms of clinically significant fatigue. Clinical fatigue measured using 4 items of the "energy/fatigue" subscale (Vt) of the Short Form Health Survey (SF - 36). Averaged score range from 100 (best) to 0 (worst): Presence of clinical fatigue if averaged SF - 36 Vt score \< 45.
Time frame: 6 months after hospital discharge
Incidence of cognitive impairment in family members of ICU survivors
Cognitive impairment measured using the memory, fluency, and orientation (MEFO) test. Summed score range from 13 (best) to 0 (worst). Presence of cognitive impairment if summed MEFO test score \< 9.
Time frame: 3 months after hospital discharge
Incidence of cognitive impairment in family members of ICU survivors
Cognitive impairment measured using the memory, fluency, and orientation (MEFO) test. Summed score range from 13 (best) to 0 (worst). Presence of cognitive impairment if summed MEFO test score \< 9.
Time frame: 6 months after hospital discharge
Symptoms of Anxiety and Depression in family members of ICU survivors
Anxiety and depressive symptoms measured using the PHQ - 4, summed score range, 0 (best) to 12 (worst)): Presence of symptoms of anxiety and depression if summed PHQ - 4 score ≥ 6.
Time frame: Between the 3rd - 7th day of ICU admission
Symptoms of Anxiety and Depression in family members of ICU survivors
Anxiety and depressive symptoms measured using the PHQ - 4, summed score range, 0 (best) to 12 (worst)): Presence of symptoms of anxiety and depression if summed PHQ - 4 score ≥ 6.
Time frame: Up to 1 week after ICU discharge
Symptoms of PTSD in family members of ICU survivors
PTSD-related symptoms measured using the IES - 6, summed score range from 0 (best) to 24 (worst)): Presence of PTSD symptoms if averaged IES - 6 score ≥ 1.75.
Time frame: Up to 1 week after ICU discharge
Physical impairment in family members of ICU survivors
Symptoms of clinically significant fatigue. Clinical fatigue measured using 4 items of the "energy/fatigue" subscale (Vt) of SF - 36. Averaged score range from 100 (best) to 0 (worst): Presence of clinical fatigue if averaged SF - 36 Vt score \< 45.
Time frame: Between the 3rd - 7th day of ICU admission
Physical impairment in family members of ICU survivors
Symptoms of clinically significant fatigue. Clinical fatigue measured using 4 items of the "energy/fatigue" subscale (Vt) of SF - 36. Averaged score range from 100 (best) to 0 (worst): Presence of clinical fatigue if averaged SF - 36 Vt score \< 45.
Time frame: Up to 1 week after ICU discharge
Cognitive impairment in family members of ICU survivors
Cognitive impairment measured using the MEFO test. Summed score range from 13 (best) to 0 (worst). Presence of cognitive impairment if summed MEFO test score \< 9.
Time frame: Between the 3rd - 7th day of ICU admission
Cognitive impairment in family members of ICU survivors
Cognitive impairment measured using the MEFO test. Summed score range from 13 (best) to 0 (worst). Presence of cognitive impairment if summed MEFO test score \< 9.
Time frame: Up to 1 week after ICU discharge
Perceived Social Support in family members of ICU survivors
Perceived social support measured using the modified 8-item version of the Medical Outcomes Study Social Support Survey (mMOS - SSS). Averaged score range from 100 (best) to 0 (worst).
Time frame: Between the 3rd - 7th day of ICU admission
Perceived Social Support in family members of ICU survivors
Perceived social support measured using the modified 8-item version of the Medical Outcomes Study Social Support Survey (mMOS - SSS). Averaged score range from 100 (best) to 0 (worst).
Time frame: Up to 1 week after ICU discharge
Perceived Social Support in family members of ICU survivors
Perceived social support measured using the modified 8-item version of the Medical Outcomes Study Social Support Survey (mMOS - SSS). Averaged score range from 100 (best) to 0 (worst).
Time frame: 3 months after hospital discharge
Perceived Social Support in family members of ICU survivors
Perceived social support measured using the modified 8-item version of the Medical Outcomes Study Social Support Survey (mMOS - SSS). Averaged score range from 100 (best) to 0 (worst).
Time frame: 6 months after hospital discharge
Resilience in family members of ICU survivors
Resilience measured using the Brief Resilient Coping Scale (BRCS). Summed score range from 20 (best) to 4 (worst). Presence of low resilience if summed BRCS score ≤ 13.
Time frame: Between the 3rd - 7th day of ICU admission
Resilience in family members of ICU survivors
Resilience measured using the Brief Resilient Coping Scale (BRCS). Summed score range from 20 (best) to 4 (worst). Presence of low resilience if summed BRCS score ≤ 13.
Time frame: Up to 1 week after ICU discharge
Resilience in family members of ICU survivors
Resilience measured using the Brief Resilient Coping Scale (BRCS). Summed score range from 20 (best) to 4 (worst). Presence of low resilience if summed BRCS score ≤ 13.
Time frame: 3 months after hospital discharge
Resilience in family members of ICU survivors
Resilience measured using the Brief Resilient Coping Scale (BRCS). Summed score range from 20 (best) to 4 (worst). Presence of low resilience if summed BRCS score ≤ 13.
Time frame: 6 months after hospital discharge
Family Satisfaction in family members of ICU survivors
Family satisfaction measured using the Family Satisfaction with Care in the Intensive Care Unit - 24 (FS ICU - 24). Averaged score range from 100 (best) to 0 (worst).
Time frame: Between the 3rd - 7th day of ICU admission
Family Satisfaction in family members of ICU survivors
Family satisfaction measured using the Family Satisfaction with Care in the Intensive Care Unit - 24 (FS ICU - 24). Averaged score range from 100 (best) to 0 (worst).
Time frame: Up to 1 week after ICU discharge
Caregiver Burden in family members of ICU survivors
Caregiver Burden measured using the 7-item version of the ZARIT Burden Interview (ZBI). Summed score range from 7 (best) to 35 (worst). Presence of intense caregiver burden if summed ZBI score ≥ 17.
Time frame: 3 months after hospital discharge
Caregiver Burden in family members of ICU survivors
Caregiver Burden measured using the 7-item version of the ZARIT Burden Interview (ZBI). Summed score range from 7 (best) to 35 (worst). Presence of intense caregiver burden if summed ZBI score ≥ 17.
Time frame: 6 months after hospital discharge
Functional Independence in ICU survivors
Patient´s functional independence using the Barthel Index (BI). Summed score range from 100 (best) to 0 (worst)
Time frame: Between the 3rd - 7th day of ICU admission (prior ICU admission status)
Functional Independence in ICU survivors
Patient´s functional independence using the Barthel Index (BI). Summed score range from 100 (best) to 0 (worst)
Time frame: Up to 1 week after ICU discharge
Functional Independence in ICU survivors
Patient´s functional independence using the Barthel Index (BI). Summed score range from 100 (best) to 0 (worst)
Time frame: 3 months after hospital discharge
Functional Independence in ICU survivors
Patient´s functional independence using the Barthel Index (BI). Summed score range from 100 (best) to 0 (worst)
Time frame: 6 months after hospital discharge
Plan to share: Undecided
Started Jun 2023 (actual). Primary completion is estimated for Nov 2025, 29 months after the start.
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