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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To determine the incidence of each PICS-F impairment (psychological, physical, and cognitive). To identify factors associated with PICS-F impairments during ICU stay and after hospital discharge.

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

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

Participation Criteria
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Eligibility Criteria
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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 7 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Family Members<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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): 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. 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. | 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): 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. 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. | 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. | 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. | 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. | 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. | 6 months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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) | 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) | 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) | 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) | 6 months after hospital discharge |