Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1346 participants
OBSERVATIONAL
2022-12-15
2024-09-13
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Family members of patients admitted to the ICU
Family members of patients admitted to the ICU
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
Health care professionals
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
Patients
Inclusion (at D3 after admission to the ICU): collection of demographic data Discharge from the ICU: characteristics of the stay and outcome (alive/deceased)
Interventions
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Family members of patients admitted to the ICU
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
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
Inclusion (at D3 after admission to the ICU): collection of demographic data Discharge from the ICU: characteristics of the stay and outcome (alive/deceased)
Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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)
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Assistance Publique Hopitaux De Marseille
OTHER
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jean REIGNIER, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CH Angoulême
Angoulême, France, France
Hôpital Privé d'Antony
Antony, France, France
CH d'Argenteuil
Argenteuil, France, France
CH de Bastia
Bastia, France, France
CH Beauvais
Beauvais, France, France
Hôpital Nord Franche Comté
Belfort, France, France
CH de Béthune
Beuvry, France, France
APHP Hôpital Avicenne
Bobigny, France, France
CHU de Bordeaux - Hôpital Saint-André
Bordeaux, France, France
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, France
AP-HP Hôpital Ambroise Paré
Boulogne, France, France
CH de Boulogne-sur-Mer
Boulogne-sur-Mer, France, France
CHU de Brest
Brest, France, France
CH de Chartres
Chartres, France, France
CH de Cholet
Cholet, France, France
CHU Clermont-Ferrand - Centre Jean Perrin
Clermont-Ferrand, France, France
CHU Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France, France
CH de Dieppe
Dieppe, France, France
CHU de Dijon
Dijon, France, France
CH de Fréjus - Saint Raphaël
Fréjus, France, France
APHP Hôpital Raymond Poincaré
Garches, France, France
CHU de Grenoble Alpes
Grenoble, France, France
GHEF- Site de Marne de la Vallée
Jossigny, France, France
CHD Vendée
La Roche-sur-Yon, France, France
CH de la Rochelle
La Rochelle, France, France
CH Versailles - Hôpital André Mignot
Le Chesnay, France, France
CH du Mans
Le Mans, France, France
CHU de Lille - Hôpital Roger Salengro
Lille, France, France
GHB Sud - Hôpital de Lorient
Lorient, France, France
CHU De Lyon - Hôpital Edouard Herriot
Lyon, France, France
AP-HM - Hôpital Nord
Marseille, France, France
Hôpital Privé Jacques Cartier
Massy, France, France
GHI le Raincy Montfermeil
Montfermeil, France, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, France
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France, France
CHU de Nantes
Nantes, France, France
Clinique Ambroise Paré
Neuilly-sur-Seine, France, France
CHR d'Orléans
Orléans, France, France
APHP Hôpital Saint-Louis
Paris, France, France
APHP Hôpital Cochin
Paris, France, France
APHP Hôpital La Pitié Salpêtrière
Paris, France, France
APHP Hôpital Tenon
Paris, France, France
APHP Hôpital Saint-Antoine
Paris, France, France
CHI Poissy
Poissy, France, France
CH René Dubos
Pontoise, France, France
CH de Saint-Lô
Saint-Lô, France, France
CH de Saint-Nazaire
Saint-Nazaire, France, France
Hôpital du Pays Salonais
Salon-de-Provence, France, France
CH de Bassin de Thau
Sète, France, France
CH de Saint-Malo
St-Malo, France, France
Hôpital Foch
Suresnes, France, France
CH de Tourcoing - Hôpital Guy Chatiliez
Tourcoing, France, France
Ch Bretagne Atlantique - site de Vannes
Vannes, France, France
CH de Vichy
Vichy, France, France
Institut Gustave Roussy
Villejuif, France, France
CHU La Guadeloupe
Pointe-à-Pitre, France, Guadeloupe
Countries
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Other Identifiers
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RC22_0078
Identifier Type: -
Identifier Source: org_study_id
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