NCT05827354

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 27, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

March 29, 2023

Last Update Submit

April 5, 2024

Conditions

Post Intensive Care SyndromeFamily MembersCaregiver BurdenCritical IllnessMental HealthPhysical HealthCognitive ImpairmentFamily SatisfactionResilienceSocial Support

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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 Outcomes (23)

  • Symptoms of Anxiety and Depression in family members of ICU survivors

    Between the 3rd - 7th day of ICU admission

  • Symptoms of Anxiety and Depression in family members of ICU survivors

    Up to 1 week after ICU discharge

  • Symptoms of PTSD in family members of ICU survivors

    Up to 1 week after ICU discharge

  • Physical impairment in family members of ICU survivors

    Between the 3rd - 7th day of ICU admission

  • Physical impairment in family members of ICU survivors

    Up to 1 week after ICU discharge

  • +18 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Dra. Eloisa I. Diaz

La Florida, RM, Chile

RECRUITING

Related Publications (13)

  • 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.

    PMID: 26792081BACKGROUND

  • 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.

    PMID: 28721340BACKGROUND

  • 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.

    PMID: 24589228BACKGROUND

  • 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.

    PMID: 27153307BACKGROUND

  • 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.

    PMID: 30950647BACKGROUND

  • 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.

    PMID: 24439845BACKGROUND

  • 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.

    PMID: 22080636BACKGROUND

  • 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.

    PMID: 27168433BACKGROUND

  • 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.

    PMID: 27065467BACKGROUND

  • 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.

    PMID: 25654174BACKGROUND

  • 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.

    PMID: 33624988BACKGROUND

  • 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.

    PMID: 32869070BACKGROUND

  • Padilla-Fortunatti C, Rojas-Silva N, Cortes-Maripangue S, Palmeiro-Silva Y, Rojas-Jara V, Nilo-Gonzalez V, Cifuentes-Avendano B, Morales-Morales D, Garces-Brito N. Incidence and factors associated with post-intensive care syndrome among caregivers of intensive care unit survivors: Protocol for a cohort study. PLoS One. 2025 May 16;20(5):e0324013. doi: 10.1371/journal.pone.0324013. eCollection 2025.

    PMID: 40378139DERIVED

MeSH Terms

Conditions

postintensive care syndromeCaregiver BurdenCritical IllnessPsychological Well-BeingCognitive Dysfunction

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Cristobal Padilla F., PhD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristobal Padilla F., PhD

CONTACT

+56964587104cfpadill@uc.cl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Nursing

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 25, 2023

Study Start

June 27, 2023

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

CL(1)