Improving FAMily Members' Experience in the ICU

Last updated: September 26, 2024
Sponsor: Nantes University Hospital
Overall Status: Completed

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Health care professionals

Patients

Family members of patients admitted to the ICU

Clinical Study ID

NCT05461521
RC22_0078
  • Ages > 18
  • All Genders

Study 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

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 hourof intubation in intensive care

  • Having been informed of the study and not having objected to the use of theirmedical medical data prior to discharge from the ICU if they are able to receive theinformation the information at the time of inclusion or consent of the family memberobtained for the inclusion of the patient if the patient is not able to do so at thetime 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 beinformed, or, in the case of a patient unable to express him/herself, identified bythe 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 avisit of the patient

  • Inclusion between H48 and H120 post-intubation of the patient in the ICU (if thepatient 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: Allprofessionals in all categories and in all participating participating services whohave been informed of the study and have consented to participate.

Exclusion

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, notresiding 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)

Study Design

Total Participants: 1346
Treatment Group(s): 3
Primary Treatment: Health care professionals
Phase:
Study Start date:
December 15, 2022
Estimated Completion Date:
September 13, 2024

Connect with a study center

  • CH Angoulême

    Angoulême, 16000
    France

    Site Not Available

  • Hôpital Privé d'Antony

    Antony, 92160
    France

    Site Not Available

  • CH d'Argenteuil

    Argenteuil, 95100
    France

    Site Not Available

  • CH de Bastia

    Bastia, 20600
    France

    Site Not Available

  • CH Beauvais

    Beauvais, 60000
    France

    Site Not Available

  • Hôpital Nord Franche Comté

    Belfort, 90015
    France

    Site Not Available

  • CH de Béthune

    Beuvry, 62660
    France

    Site Not Available

  • APHP Hôpital Avicenne

    Bobigny, 9300
    France

    Site Not Available

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • CHU de Bordeaux - Hôpital Saint-André

    Bordeaux, 33000
    France

    Site Not Available

  • AP-HP Hôpital Ambroise Paré

    Boulogne, 92104
    France

    Site Not Available

  • CH de Boulogne-sur-Mer

    Boulogne-sur-Mer, 62231
    France

    Site Not Available

  • CHU de Brest

    Brest, 29609
    France

    Site Not Available

  • CH Intercommunal Nord-Ardennes

    Charleville-Mézières, 08000
    France

    Site Not Available

  • CH de Chartres

    Chartres, 28000
    France

    Site Not Available

  • CH de Cholet

    Cholet, 49300
    France

    Site Not Available

  • CHU Clermont-Ferrand - Centre Jean Perrin

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • CHU Clermont-Ferrand - Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003
    France

    Site Not Available

  • CH Sud Francilien

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • CH de Dieppe

    Dieppe, 76200
    France

    Site Not Available

  • CHU de Dijon

    Dijon, 21033
    France

    Site Not Available

  • CH de Fréjus - Saint Raphaël

    Fréjus, 83608
    France

    Site Not Available

  • APHP Hôpital Raymond Poincaré

    Garches, 92380
    France

    Site Not Available

  • CHU de Grenoble Alpes

    Grenoble, 38043
    France

    Site Not Available

  • GHEF- Site de Marne de la Vallée

    Jossigny, 77600
    France

    Site Not Available

  • CHD Vendée

    La Roche-sur-Yon, 85000
    France

    Site Not Available

  • CH de la Rochelle

    La Rochelle, 17019
    France

    Site Not Available

  • CH Versailles - Hôpital André Mignot

    Le Chesnay, 78150
    France

    Site Not Available

  • CH du Mans

    Le Mans, 72000
    France

    Site Not Available

  • CHU de Lille - Hôpital Roger Salengro

    Lille, 59045
    France

    Site Not Available

  • GHICL - Hôpital Saint-Philibert

    Lomme, 59462
    France

    Site Not Available

  • GHB Sud - Hôpital de Lorient

    Lorient, 56322
    France

    Site Not Available

  • CHU De Lyon - Hôpital Edouard Herriot

    Lyon, 69437
    France

    Site Not Available

  • AP-HM - Hôpital Nord

    Marseille, 13915
    France

    Site Not Available

  • Hôpital Privé Jacques Cartier

    Massy, 91300
    France

    Site Not Available

  • CHR Metz Thionville - Hôpital de Mercy

    Metz, 57085
    France

    Site Not Available

  • GHI le Raincy Montfermeil

    Montfermeil, 93370
    France

    Site Not Available

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295
    France

    Site Not Available

  • CHU de Montpellier - Hôpital Saint-Eloi

    Montpellier, 34295
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44000
    France

    Site Not Available

  • Clinique Ambroise Paré

    Neuilly-sur-Seine, 45100
    France

    Site Not Available

  • CHR d'Orléans

    Orléans, 45100
    France

    Site Not Available

  • APHP Hôpital Cochin

    Paris, 75013
    France

    Site Not Available

  • APHP Hôpital La Pitié Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • APHP Hôpital Saint-Antoine

    Paris, 75571
    France

    Site Not Available

  • APHP Hôpital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • APHP Hôpital Tenon

    Paris, 75020
    France

    Site Not Available

  • CHI Poissy

    Poissy, 78300
    France

    Site Not Available

  • CH René Dubos

    Pontoise, 95300
    France

    Site Not Available

  • CH de Rodez

    Rodez, 12027
    France

    Site Not Available

  • CH de Saint-Lô

    Saint-Lô, 50000
    France

    Site Not Available

  • CH de Saint-Malo

    Saint-Malo, 35403
    France

    Site Not Available

  • CH de Saint-Nazaire

    Saint-Nazaire, 44600
    France

    Site Not Available

  • Hôpital du Pays Salonais

    Salon-de-Provence, 13300
    France

    Site Not Available

  • Hôpital Foch

    Suresnes, 92150
    France

    Site Not Available

  • CH de Bassin de Thau

    Sète, 34200
    France

    Site Not Available

  • CH de Tourcoing - Hôpital Guy Chatiliez

    Tourcoing, 59208
    France

    Site Not Available

  • Ch Bretagne Atlantique - site de Vannes

    Vannes, 59300
    France

    Site Not Available

  • CH de Vichy

    Vichy, 03200
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • CHU La Guadeloupe

    Pointe-à-Pitre, France 97110
    Guadeloupe

    Site Not Available

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