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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827354
• Other study ID #: Fondecyt Iniciacion 11230203
• Secondary ID: 11230203
• Status: Recruiting
• Start date: June 27, 2023
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: Pontificia Universidad Catolica de Chile
• Contact: Cristobal Padilla F., PhD
• Phone: +56964587104
• Email: cfpadill[@]uc.cl
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Locations

Country	Name	City	State
Chile	Hospital Clinico Dra. Eloisa I. Diaz	La Florida	RM

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Agencia Nacional de Investigación y Desarrollo

Country where clinical trial is conducted

Chile, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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