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

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

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.

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 175

Contacts and Locations

• Study Contact: Name: Cristobal Padilla F., PhD; Phone Number: +56964587104; Email: cfpadill@uc.cl

Study Locations

• Chile
  • RM
    • La Florida, RM, Chile
      • Recruiting
      • Hospital Clinico Dra. Eloisa I. Diaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Family members of ICU survivors in a public hospital in Santiago, Chile who meet the inclusion criteria will be invited to the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Family Members; 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?

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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: Agencia Nacional de Investigación y Desarrollo
• Investigators: Principal Investigator: Cristobal Padilla F., PhD, Pontificia Universidad Catolica de Chile

Publications and helpful links

General Publications

• van Beusekom I, Bakhshi-Raiez F, de Keizer NF, Dongelmans DA, van der Schaaf M. Reported burden on informal caregivers of ICU survivors: a literature review. Crit Care. 2016 Jan 21;20:16. doi: 10.1186/s13054-016-1185-9.
• Cameron JI, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, dos Santos C, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Herridge MS; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. One-Year Outcomes in Caregivers of Critically Ill Patients. N Engl J Med. 2016 May 12;374(19):1831-41. doi: 10.1056/NEJMoa1511160.
• Rawal G, Yadav S, Kumar R. Post-intensive Care Syndrome: an Overview. J Transl Int Med. 2017 Jun 30;5(2):90-92. doi: 10.1515/jtim-2016-0016. eCollection 2017 Jun.
• Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
• Kean S, Smith GD. Editorial: surviving critical illness: intensive care and beyond. J Clin Nurs. 2014 Mar;23(5-6):603-4. doi: 10.1111/jocn.12555. No abstract available.
• Davidson JE, Harvey MA. Patient and Family Post-Intensive Care Syndrome. AACN Adv Crit Care. 2016 Apr-Jun;27(2):184-6. doi: 10.4037/aacnacc2016132. No abstract available.
• Johnson CC, Suchyta MR, Darowski ES, Collar EM, Kiehl AL, Van J, Jackson JC, Hopkins RO. Psychological Sequelae in Family Caregivers of Critically III Intensive Care Unit Patients. A Systematic Review. Ann Am Thorac Soc. 2019 Jul;16(7):894-909. doi: 10.1513/AnnalsATS.201808-540SR.
• Choi J, Tate JA, Hoffman LA, Schulz R, Ren D, Donahoe MP, Given BA, Sherwood PR. Fatigue in family caregivers of adult intensive care unit survivors. J Pain Symptom Manage. 2014 Sep;48(3):353-63. doi: 10.1016/j.jpainsymman.2013.09.018. Epub 2014 Jan 16.
• Nadig N, Huff NG, Cox CE, Ford DW. Coping as a Multifaceted Construct: Associations With Psychological Outcomes Among Family Members of Mechanical Ventilation Survivors. Crit Care Med. 2016 Sep;44(9):1710-7. doi: 10.1097/CCM.0000000000001761.
• Haines KJ, Denehy L, Skinner EH, Warrillow S, Berney S. Psychosocial outcomes in informal caregivers of the critically ill: a systematic review. Crit Care Med. 2015 May;43(5):1112-20. doi: 10.1097/CCM.0000000000000865.
• Padilla Fortunatti C, De Santis JP, Munro CL. Family Satisfaction in the Adult Intensive Care Unit: A Concept Analysis. ANS Adv Nurs Sci. 2021 Oct-Dec 01;44(4):291-305. doi: 10.1097/ANS.0000000000000360.
• Beesley SJ, Hirshberg EL, Wilson EL, Butler JM, Oniki TA, Kuttler KG, Orme JF, Hopkins RO, Brown SM. Depression and Change in Caregiver Burden Among Family Members of Intensive Care Unit Survivors. Am J Crit Care. 2020 Sep 1;29(5):350-357. doi: 10.4037/ajcc2020181.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Disease; Stress, Psychological; Syndrome; Critical Illness; Caregiver Burden
• Other Study ID Numbers: Fondecyt Iniciacion 11230203; 11230203 (Other Grant/Funding Number: ANID / FONDECYT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No