Clinical trial NCT05461521: Improving FAMily Members' Experience in the ICU
Official title: Post-traumatic Stress Disorder in Relatives of Patients Admitted to the ICU: a Multicenter, Observational, Prospective Study (FAME Observational)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Disorders, Post-Traumatic
Family Members
Keywords: Family Members of a Patient Hospitalized in Intensive Care
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: Assistance Publique Hopitaux De Marseille
First posted: 2022-07-18
Enrollment: 1346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: To determine the factors associated with post-traumatic stress disorder (PTSD) in family members of patients admitted to the ICU, and.
timeFrame: at 3 months after the patient's discharge from the ICU
measure: To define a predictive model of PTSD in this population
timeFrame: at 3 months after the patient's discharge from the ICU
Secondary outcomes:
measure: Assessing the psychological impact of a family member stay in intensive care
timeFrame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
measure: Assessing the psychological impact of a family member stay in intensive care
timeFrame: 6 months after the patient's discharge from the ICU
measure: Assessing the psychological impact of a family member stay in intensive care
timeFrame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
measure: Assessing the psychological impact of a family member stay in intensive care
timeFrame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
measure: Assessing the psychological impact of a family member stay in intensive care
timeFrame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
measure: Assessing the psychological impact of a family member stay in intensive care
timeFrame: at 6 months after the patient's death in intensive care
measure: To identify the impact on the consumption of care and medical procedures of PTSD in family members of patients admitted to the ICU
timeFrame: at 3 and 6 months after discharge of the patient from the intensive care unit
Other outcomes:
measure: Qualitative study
timeFrame: 3 to 4 months after the patient's death or discharge of the patient from the intensive care unit
measure: FAME ICU Team (FIT) study
timeFrame: at the beginning of the study in the department
measure: FAME Bio-bank: Analysis of molecular signatures of PTSD
timeFrame: to the inclusion
Locations:
city: Angoulême
country: France
facility: CH Angoulême
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Argenteuil
country: France
facility: CH d'Argenteuil
city: Bastia
country: France
facility: CH de Bastia
city: Beauvais
country: France
facility: CH Beauvais
city: Belfort
country: France
facility: Hôpital Nord Franche Comté
city: Beuvry
country: France
facility: CH de Béthune
city: Bobigny
country: France
facility: APHP Hôpital Avicenne
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Saint-André
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
city: Boulogne-sur-Mer
country: France
facility: CH de Boulogne-sur-Mer
city: Boulogne
country: France
facility: AP-HP Hôpital Ambroise Paré
city: Brest
country: France
facility: CHU de Brest
city: Chartres
country: France
facility: CH de Chartres
city: Cholet
country: France
facility: CH de Cholet
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Centre Jean Perrin
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied
city: Dieppe
country: France
facility: CH de Dieppe
city: Dijon
country: France
facility: CHU de Dijon
city: Fréjus
country: France
facility: CH de Fréjus - Saint Raphaël
city: Garches
country: France
facility: APHP Hôpital Raymond Poincaré
city: Grenoble
country: France
facility: CHU de Grenoble Alpes
city: Jossigny
country: France
facility: GHEF- Site de Marne de la Vallée
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: CH de la Rochelle
city: Le Chesnay
country: France
facility: CH Versailles - Hôpital André Mignot
city: Le Mans
country: France
facility: CH du Mans
city: Lille
country: France
facility: CHU de Lille - Hôpital Roger Salengro
city: Lorient
country: France
facility: GHB Sud - Hôpital de Lorient
city: Lyon
country: France
facility: CHU De Lyon - Hôpital Edouard Herriot
city: Marseille
country: France
facility: AP-HM - Hôpital Nord
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Montfermeil
country: France
facility: GHI le Raincy Montfermeil
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nantes
country: France
facility: CHU de Nantes
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré
city: Orléans
country: France
facility: CHR d'Orléans
city: Paris
country: France
facility: APHP Hôpital Saint-Louis
city: Paris
country: France
facility: APHP Hôpital Cochin
city: Paris
country: France
facility: APHP Hôpital La Pitié Salpêtrière
city: Paris
country: France
facility: APHP Hôpital Tenon
city: Paris
country: France
facility: APHP Hôpital Saint-Antoine
city: Poissy
country: France
facility: CHI Poissy
city: Pontoise
country: France
facility: CH René Dubos
city: Saint-Lô
country: France
facility: CH de Saint-Lô
city: Saint-Malo
country: France
facility: CH de Saint-Malo
city: Saint-Nazaire
country: France
facility: CH de Saint-Nazaire
city: Salon-de-Provence
country: France
facility: Hôpital du Pays Salonais
city: Suresnes
country: France
facility: Hôpital Foch
city: Sète
country: France
facility: CH de Bassin de Thau
city: Tourcoing
country: France
facility: CH de Tourcoing - Hôpital Guy Chatiliez
city: Vannes
country: France
facility: Ch Bretagne Atlantique - site de Vannes
city: Vichy
country: France
facility: CH de Vichy
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU La Guadeloupe
state: France
Study officials:
affiliation: Nantes University Hospital
name: Jean REIGNIER, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: