Clinical trial NCT05827354: Incidence and Factors Associated to the Development of PICS-F Among ICU Relatives: A Longitudinal Exploratory Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Intensive Care Syndrome
Family Members
Caregiver Burden
Critical Illness
Mental Health
Physical Health
Cognitive Impairment
Family Satisfaction
Resilience
Social Support
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Agencia Nacional de Investigación y Desarrollo
First posted: 2023-04-25
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of psychological impairment in family members of ICU survivors
timeFrame: 3 months after hospital discharge
measure: Incidence of psychological impairment in family members of ICU survivors
timeFrame: 6 months after hospital discharge
measure: Incidence of physical impairment in family members of ICU survivors
timeFrame: 3 months after hospital discharge
measure: Incidence of physical impairment in family members of ICU survivors
timeFrame: 6 months after hospital discharge
measure: Incidence of cognitive impairment in family members of ICU survivors
timeFrame: 3 months after hospital discharge
measure: Incidence of cognitive impairment in family members of ICU survivors
timeFrame: 6 months after hospital discharge
Secondary outcomes:
measure: Symptoms of Anxiety and Depression in family members of ICU survivors
timeFrame: Between the 3rd - 7th day of ICU admission
measure: Symptoms of Anxiety and Depression in family members of ICU survivors
timeFrame: Up to 1 week after ICU discharge
measure: Symptoms of PTSD in family members of ICU survivors
timeFrame: Up to 1 week after ICU discharge
measure: Physical impairment in family members of ICU survivors
timeFrame: Between the 3rd - 7th day of ICU admission
measure: Physical impairment in family members of ICU survivors
timeFrame: Up to 1 week after ICU discharge
measure: Cognitive impairment in family members of ICU survivors
timeFrame: Between the 3rd - 7th day of ICU admission
measure: Cognitive impairment in family members of ICU survivors
timeFrame: Up to 1 week after ICU discharge
measure: Perceived Social Support in family members of ICU survivors
timeFrame: Between the 3rd - 7th day of ICU admission
measure: Perceived Social Support in family members of ICU survivors
timeFrame: Up to 1 week after ICU discharge
measure: Perceived Social Support in family members of ICU survivors
timeFrame: 3 months after hospital discharge
measure: Perceived Social Support in family members of ICU survivors
timeFrame: 6 months after hospital discharge
measure: Resilience in family members of ICU survivors
timeFrame: Between the 3rd - 7th day of ICU admission
measure: Resilience in family members of ICU survivors
timeFrame: Up to 1 week after ICU discharge
measure: Resilience in family members of ICU survivors
timeFrame: 3 months after hospital discharge
measure: Resilience in family members of ICU survivors
timeFrame: 6 months after hospital discharge
measure: Family Satisfaction in family members of ICU survivors
timeFrame: Between the 3rd - 7th day of ICU admission
measure: Family Satisfaction in family members of ICU survivors
timeFrame: Up to 1 week after ICU discharge
measure: Caregiver Burden in family members of ICU survivors
timeFrame: 3 months after hospital discharge
measure: Caregiver Burden in family members of ICU survivors
timeFrame: 6 months after hospital discharge
measure: Functional Independence in ICU survivors
timeFrame: Between the 3rd - 7th day of ICU admission (prior ICU admission status)
measure: Functional Independence in ICU survivors
timeFrame: Up to 1 week after ICU discharge
measure: Functional Independence in ICU survivors
timeFrame: 3 months after hospital discharge
measure: Functional Independence in ICU survivors
timeFrame: 6 months after hospital discharge
Other outcomes:
Locations:
city: La Florida
country: Chile
facility: Hospital Clinico Dra. Eloisa I. Diaz
state: RM
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Cristobal Padilla F., PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
citation: 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.