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Completed

NCT Number: NCT05461521

Improving FAMily Members' Experience in the ICU

The aim of the present research is to set up a large multicentric, prospective cohort of family members of patients admitted to intensive care. The data collected will concern the patients and their family members, the caregivers and the functioning of the services during the collection period. This cohort will allow:

1. to carry out a quantitative evaluation of post-traumatic stress disorder (PTSD) in a large number of family members, to determine the risk factors in relation to the characteristics of the family members, and to define a predictive model of PTSD in this population 2. to determine the factors related to the operating conditions of the resuscitation services that favor the occurrence of PTSD in the family members, 3. to create a biological bank from blood samples taken from family members, 4. to carry out a qualitative study allowing a psychological and sociological analysis of the experience of the family members concerning the hospitalization in intensive care of their loved one.

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Key information

Conditions

Stress Disorders, Post-Traumatic Family Members Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Angoulême, Angoulême, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients :

  • ≥18 years old
  • Treated in the ICU with invasive mechanical ventilation for 48 hours
  • Having been visited by at least one family member within 72 hours of the 48th hour of intubation in intensive care
  • Having been informed of the study and not having objected to the use of their medical medical data prior to discharge from the ICU if they are able to receive the information the information at the time of inclusion or consent of the family member obtained for the inclusion of the patient if the patient is not able to do so at the time of at the time of inclusion

Family members :

  • ≥18 years old
  • Identified if possible by the patient as the person to be referred or to be informed, or, in the case of a patient unable to express him/herself, identified by the caregivers as the "patient's close referent".
  • Understanding and speaking French
  • Having been informed of the study and having consented to participate in it during a visit of the patient
  • Inclusion between H48 and H120 post-intubation of the patient in the ICU (if the patient is still intubated at the time of inclusion)
  • Having given their telephone number
  • Being covered by a social security plan.
  • Only one relative of the patient is included in the study Service Professionals: All professionals in all categories and in all participating participating services who have been informed of the study and have consented to participate.

Exclusion criteria

Patients:

  • No family member or no family member visit
  • No consent to participate from family member
  • Organ donation planned or contemplated
  • Pregnant or parturient woman
  • Detained or deprived of liberty
  • Under guardianship or curator
  • No social security

Family members :

  • Social context making follow-up and telephone interviews difficult (homeless, not residing in Europe or in the DOM)
  • Inability to give a "stable" personal cell phone number
  • Under guardianship or curator
  • Unable to communicate on the phone (hearing impairment...)

Service Professionals:

  • Not on duty (locum tenens or interim team, only on-call) on call)
  • Not qualified (Physician: at least intern, nurse DE)

Treatment and study plan

Family members of patients admitted to the ICU

Other

At inclusion:

  • Collection of demographic data, Anxiety-Depression Scale (HADS), Insomnia Severity Index (ISI), Resilience Insomnia Severity Index (ISI), Resilience Scale (CD RISC 10), Peritraumatic Dissociation Peritraumatic Dissociation Experience Scale (PDEQ) and MEDEC questionnaire.
  • Venous blood sampling at 350 relatives
  • Upon discharge of the patient (alive or deceased): Resuscitation questionnaire, HADS, ISI and PDEQ.

3 months after discharge: Demographic questionnaire, Post Traumatic Stress Disorder questionnaire (PCL-5), THS Past Trauma Experience Questionnaire, HADS experiences, HADS, ISI, CD RISC 10, MEDEC and Who- assist questionnaire (Question 2) on the use of psychoactive substances.

6 months after patient discharge: PCL-5, HADS, ISI, CD RISC 10, MEDEC, Who-assist (Question 2) and Prolonged Grief disorder (PG-13) questionnaire on bereavement if patient died in the ICU.

Health care professionals

Other

All professionals in all categories and in all participating departments will be asked to complete questionnaires to assess the level of conflict, work stress and burn out in the units : Masclach Burnout Inventory (MBI), Job Content Questionnaire (JCQ), Ethical Decision-Making Climate Questionnaire (EDMCQ), Professional Quality Of Life scale (ProQOL), Connor-Davidson Resilience scale (CD-RISC 10), Cultural Awareness Scale (CAS).

Patients

Other

Inclusion (at D3 after admission to the ICU): collection of demographic data Discharge from the ICU: characteristics of the stay and outcome (alive/deceased)

Primary outcomes

  1. To determine the factors associated with post-traumatic stress disorder (PTSD) in family members of patients admitted to the ICU, and.

    Time frame: at 3 months after the patient's discharge from the ICU

    The primary endpoint is the proportion of family members who developed PTSD 3 months after the patient's discharge from the ICU assessed by the Post-traumatic stress disorder CheckList (PCL-5) version Diagnostic and Statistical Manual of Mental Disorders (DSM-5) scale. This scale consists of 20 items on the symptoms of PTSD according to the DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely"). The maximum score is 80.

  2. To define a predictive model of PTSD in this population

    Time frame: at 3 months after the patient's discharge from the ICU

    The primary endpoint is the proportion of family members who developed PTSD 3 months after the patient's discharge from the ICU assessed by the Post-traumatic stress disorder CheckList (PCL-5) version Diagnostic and Statistical Manual of Mental Disorders (DSM-5) scale. This scale consists of 20 items on the symptoms of PTSD according to the DSM-5 criteria. Each item is rated from 0 ("not at all") to 4 ("extremely"). The maximum score is 80.

Secondary outcomes

  1. Assessing the psychological impact of a family member stay in intensive care

    Time frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU

    Proportion of family members who developed symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS),

  2. Assessing the psychological impact of a family member stay in intensive care

    Time frame: 6 months after the patient's discharge from the ICU

    Proportion of family members who developed PTSD 6 months after discharge from the assessed by the PCL-5 scale

  3. Assessing the psychological impact of a family member stay in intensive care

    Time frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU

    Proportion of relatives who developed severe insomnia assessed by the Insomnia Severity Index (ISI)

  4. Assessing the psychological impact of a family member stay in intensive care

    Time frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU

    Proportion of resilient relatives assessed by Resilience Scale (CD RISC 10)

  5. Assessing the psychological impact of a family member stay in intensive care

    Time frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU

    Proportion of relatives who developed peri-traumatic dissociation experiences (PDEQ)

  6. Assessing the psychological impact of a family member stay in intensive care

    Time frame: at 6 months after the patient's death in intensive care

    Proportion of relatives who developed prolonged grief assessed by the Prolonged Grief disorder (PG-13) questionnaire

  7. To identify the impact on the consumption of care and medical procedures of PTSD in family members of patients admitted to the ICU

    Time frame: at 3 and 6 months after discharge of the patient from the intensive care unit

    Proportion of relatives who used psychoactive substances assessed by the Who-assist questionnaire (Question 2 of the questionnaire), Consumption of care and medical procedures by relatives (MEDEC questionnaire

Other outcomes

  1. Qualitative study

    Time frame: 3 to 4 months after the patient's death or discharge of the patient from the intensive care unit

    To deepen the understanding of the mechanisms leading to post-traumatic stress disorder in relatives of patients admitted to the ICU

    • Semi-structured interviews conducted by a psychologist or a sociologist
    • Population concerned by the interviews:
    • relatives of non deceased patients (n= 20)
    • bereaved relatives (patient who died in intensive care) (n= 20)
    • nurses (n= 20) and intensive care physicians (n= 20).

  2. FAME ICU Team (FIT) study

    Time frame: at the beginning of the study in the department

    to determine the individual and organizational (unit-related) factors associated with the risk of burnout among service professionals, and to identify a possible association between the presence of burnout and the ethical climate in which the professional working in the unit operates burnout and the ethical climate in which the professional working in the resuscitation.

    Scales completed by caregivers :

    • Maslach Burnout Inventory (MBI) for the assessment of burnout
    • Job Content Questionnaire (JCQ) for the assessment of job stress months").
    • Ethical Decision-Making Climate Questionnaire (EDMCQ) for the evaluation of the ethical climate
    • Professional Quality Of Life scale (ProQOL) for the assessment of quality of life at work
    • Connor-Davidson Resilience scale (CD-RISC 10) to assess resilience
    • Cultural Awareness Scale (CAS)

  3. FAME Bio-bank: Analysis of molecular signatures of PTSD

    Time frame: to the inclusion

    The main objective is to provide a prediction of the risk of PTSD that is as close as possible to to the individuals concerned.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Assistance Publique Hopitaux De Marseille

Registry information

Official study title

Post-traumatic Stress Disorder in Relatives of Patients Admitted to the ICU: a Multicenter, Observational, Prospective Study (FAME Observational)

Acronym: FAME

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2022
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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