Improving FAMily Members' Experience in the ICU

Study Overview
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Brief Summary
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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: 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 to determine the factors related to the operating conditions of the resuscitation services that favor the occurrence of PTSD in the family members, to create a biological bank from blood samples taken from family members, 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.

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

Conditions
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Stress Disorders, Post-Traumatic, Family Members

Intervention / Treatment
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* Other: Family members of patients admitted to the ICU
* Other: Health care professionals
* Other: Patients


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Family members of patients admitted to the ICU<br> | Other: Family members of patients admitted to the ICU<br>* 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.<br>|
| Health care professionals<br> | Other: Health care professionals<br>* 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).<br>|
| Patients<br> | Other: Patients<br>* Inclusion (at D3 after admission to the ICU): collection of demographic data Discharge from the ICU: characteristics of the stay and outcome (alive/deceased)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the factors associated with post-traumatic stress disorder (PTSD) in family members of patients admitted to the ICU, and. | 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. | at 3 months after the patient's discharge from the ICU | 
| To define a predictive model of PTSD in this population | 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. | at 3 months after the patient's discharge from the ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the psychological impact of a family member stay in intensive care | Proportion of family members who developed symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS), | at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU | 
| Assessing the psychological impact of a family member stay in intensive care | Proportion of family members who developed PTSD 6 months after discharge from the assessed by the PCL-5 scale | 6 months after the patient's discharge from the ICU | 
| Assessing the psychological impact of a family member stay in intensive care | Proportion of relatives who developed severe insomnia assessed by the Insomnia Severity Index (ISI) | at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU | 
| Assessing the psychological impact of a family member stay in intensive care | Proportion of resilient relatives assessed by Resilience Scale (CD RISC 10) | at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU | 
| Assessing the psychological impact of a family member stay in intensive care | Proportion of relatives who developed peri-traumatic dissociation experiences (PDEQ) | at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU | 
| Assessing the psychological impact of a family member stay in intensive care | Proportion of relatives who developed prolonged grief assessed by the Prolonged Grief disorder (PG-13) questionnaire | at 6 months after the patient's death in intensive care | 
| To identify the impact on the consumption of care and medical procedures of PTSD in family members of patients admitted to the ICU | 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 | at 3 and 6 months after discharge of the patient from the intensive care unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Members of a Patient Hospitalized in Intensive Care