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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
| Assistance Publique Hopitaux De Marseille | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family members of patients admitted to the ICU |
| ||
| Health care professionals |
| ||
| Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family members of patients admitted to the ICU | Other | At inclusion:
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative study | To deepen the understanding of the mechanisms leading to post-traumatic stress disorder in relatives of patients admitted to the ICU
|
Inclusion Criteria:
Patients :
Family members :
Exclusion Criteria:
Patients:
Family members :
Service Professionals:
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Family members : 1346 family members of 1346 patients admitted to the ICU and treated with invasive mechanical ventilation will be included in the research. Only one person among the patient's family members will be concerned by the study. The inclusion window will be 72 hours, starting from the 48th hour after the patient's intubation in the ICU and ending at the 120th hour after intubation.
Patients: 1346 patients treated with invasive mechanical ventilation will be included in this research. Information about the study will be given to the patient at the same time as to the family member if the patient is conscious, or as soon he is able to receive the information.
Caregivers: All professionals in all categories and in all participating departments will be asked to complete questionnaires to assess the level of stress and burn out in the units. Participation in the study will be participation in the study will be offered to them at the beginning of the study in the department.
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| Name | Affiliation | Role |
|---|---|---|
| Jean REIGNIER, PU-PH | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Angoulême | Angoulême | France | 16000 | France | ||
| Hôpital Privé d'Antony |
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Objective: to identify biomarkers of PTSD in family members of patients admitted to 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) |
|
| 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 |
| 3 to 4 months after the patient's death or discharge of the patient from the intensive care unit |
| FAME ICU Team (FIT) study | 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 :
| at the beginning of the study in the department |
| FAME Bio-bank: Analysis of molecular signatures of PTSD | The main objective is to provide a prediction of the risk of PTSD that is as close as possible to to the individuals concerned. | to the inclusion |
| Antony |
| France |
| 92160 |
| France |
| CH d'Argenteuil | Argenteuil | France | 95100 | France |
| CH de Bastia | Bastia | France | 20600 | France |
| CH Beauvais | Beauvais | France | 60000 | France |
| Hôpital Nord Franche Comté | Belfort | France | 90015 | France |
| CH de Béthune | Beuvry | France | 62660 | France |
| APHP Hôpital Avicenne | Bobigny | France | 9300 | France |
| CHU de Bordeaux - Hôpital Saint-André | Bordeaux | France | 33000 | France |
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | France | 33076 | France |
| AP-HP Hôpital Ambroise Paré | Boulogne | France | 92104 | France |
| CH de Boulogne-sur-Mer | Boulogne-sur-Mer | France | 62231 | France |
| CHU de Brest | Brest | France | 29609 | France |
| CH de Chartres | Chartres | France | 28000 | France |
| CH de Cholet | Cholet | France | 49300 | France |
| CHU Clermont-Ferrand - Centre Jean Perrin | Clermont-Ferrand | France | 63000 | France |
| CHU Clermont-Ferrand - Hôpital Gabriel Montpied | Clermont-Ferrand | France | 63003 | France |
| CH de Dieppe | Dieppe | France | 76200 | France |
| CHU de Dijon | Dijon | France | 21033 | France |
| CH de Fréjus - Saint Raphaël | Fréjus | France | 83608 | France |
| APHP Hôpital Raymond Poincaré | Garches | France | 92380 | France |
| CHU de Grenoble Alpes | Grenoble | France | 38043 | France |
| GHEF- Site de Marne de la Vallée | Jossigny | France | 77600 | France |
| CHD Vendée | La Roche-sur-Yon | France | 85000 | France |
| CH de la Rochelle | La Rochelle | France | 17019 | France |
| CH Versailles - Hôpital André Mignot | Le Chesnay | France | 78150 | France |
| CH du Mans | Le Mans | France | 72000 | France |
| CHU de Lille - Hôpital Roger Salengro | Lille | France | 59045 | France |
| GHB Sud - Hôpital de Lorient | Lorient | France | 56322 | France |
| CHU De Lyon - Hôpital Edouard Herriot | Lyon | France | 69437 | France |
| AP-HM - Hôpital Nord | Marseille | France | 13915 | France |
| Hôpital Privé Jacques Cartier | Massy | France | 91300 | France |
| GHI le Raincy Montfermeil | Montfermeil | France | 93370 | France |
| CHU de Montpellier - Hôpital Lapeyronie | Montpellier | France | 34295 | France |
| CHU de Montpellier - Hôpital Saint-Eloi | Montpellier | France | 34295 | France |
| CHU de Nantes | Nantes | France | 44000 | France |
| Clinique Ambroise Paré | Neuilly-sur-Seine | France | 45100 | France |
| CHR d'Orléans | Orléans | France | 45100 | France |
| APHP Hôpital Saint-Louis | Paris | France | 75010 | France |
| APHP Hôpital Cochin | Paris | France | 75013 | France |
| APHP Hôpital La Pitié Salpêtrière | Paris | France | 75013 | France |
| APHP Hôpital Tenon | Paris | France | 75020 | France |
| APHP Hôpital Saint-Antoine | Paris | France | 75571 | France |
| CHI Poissy | Poissy | France | 78300 | France |
| CH René Dubos | Pontoise | France | 95300 | France |
| CH de Saint-Lô | Saint-Lô | France | 50000 | France |
| CH de Saint-Nazaire | Saint-Nazaire | France | 44600 | France |
| Hôpital du Pays Salonais | Salon-de-Provence | France | 13300 | France |
| CH de Bassin de Thau | Sète | France | 34200 | France |
| CH de Saint-Malo | St-Malo | France | 35403 | France |
| Hôpital Foch | Suresnes | France | 92150 | France |
| CH de Tourcoing - Hôpital Guy Chatiliez | Tourcoing | France | 59208 | France |
| Ch Bretagne Atlantique - site de Vannes | Vannes | France | 59300 | France |
| CH de Vichy | Vichy | France | 03200 | France |
| Institut Gustave Roussy | Villejuif | France | 94805 | France |
| CHU La Guadeloupe | Pointe-à-Pitre | France | 97110 | Guadeloupe |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006282 | Health Personnel |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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