Improving FAMily Members' Experience in the ICU

NCT05461521 | Completed

• 1 other identifier: RC22_0078
• Study Type: observational
• Target: 1,346
• Locations: 2 countries
• Sites: 56

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. 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. 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. 3.to create a biological bank from blood samples taken from family members,
4. 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.

Conditions

Stress Disorders, Post-Traumatic; Family Members

Keywords

Family Members of a Patient Hospitalized in Intensive Care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Assessing the psychological impact of a family member stay in intensive care

  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

  6 months after the patient's discharge from the ICU

• Assessing the psychological impact of a family member stay in intensive care

  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

  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

  at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU

Other Outcomes (3)

• Qualitative study

  3 to 4 months after the patient's death or discharge of the patient from the intensive care unit

• FAME ICU Team (FIT) study

  at the beginning of the study in the department

• FAME Bio-bank: Analysis of molecular signatures of PTSD

  to the inclusion

Study Arms (3)

Family members of patients admitted to the ICU

Other: Family members of patients admitted to the ICU

Health care professionals

Other: Health care professionals

Patients

Other: Patients

Interventions

Family members of patients admitted to the ICU OTHER

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.

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).

Health care professionals

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)

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead
• Assistance Publique - Hôpitaux de Paris: collaborator
• Assistance Publique Hopitaux De Marseille: collaborator

Study Sites (56)

CH Angoulême

Angoulême, France, 16000, France

Location

Hôpital Privé d'Antony

Antony, France, 92160, France

Location

CH d'Argenteuil

Argenteuil, France, 95100, France

Location

CH de Bastia

Bastia, France, 20600, France

Location

CH Beauvais

Beauvais, France, 60000, France

Location

Hôpital Nord Franche Comté

Belfort, France, 90015, France

Location

CH de Béthune

Beuvry, France, 62660, France

Location

APHP Hôpital Avicenne

Bobigny, France, 9300, France

Location

CHU de Bordeaux - Hôpital Saint-André

Bordeaux, France, 33000, France

Location

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France, 33076, France

Location

AP-HP Hôpital Ambroise Paré

Boulogne, France, 92104, France

Location

CH de Boulogne-sur-Mer

Boulogne-sur-Mer, France, 62231, France

Location

CHU de Brest

Brest, France, 29609, France

Location

CH de Chartres

Chartres, France, 28000, France

Location

CH de Cholet

Cholet, France, 49300, France

Location

CHU Clermont-Ferrand - Centre Jean Perrin

Clermont-Ferrand, France, 63000, France

Location

CHU Clermont-Ferrand - Hôpital Gabriel Montpied

Clermont-Ferrand, France, 63003, France

Location

CH de Dieppe

Dieppe, France, 76200, France

Location

CHU de Dijon

Dijon, France, 21033, France

Location

CH de Fréjus - Saint Raphaël

Fréjus, France, 83608, France

Location

APHP Hôpital Raymond Poincaré

Garches, France, 92380, France

Location

CHU de Grenoble Alpes

Grenoble, France, 38043, France

Location

GHEF- Site de Marne de la Vallée

Jossigny, France, 77600, France

Location

CHD Vendée

La Roche-sur-Yon, France, 85000, France

Location

CH de la Rochelle

La Rochelle, France, 17019, France

Location

CH Versailles - Hôpital André Mignot

Le Chesnay, France, 78150, France

Location

CH du Mans

Le Mans, France, 72000, France

Location

CHU de Lille - Hôpital Roger Salengro

Lille, France, 59045, France

Location

GHB Sud - Hôpital de Lorient

Lorient, France, 56322, France

Location

CHU De Lyon - Hôpital Edouard Herriot

Lyon, France, 69437, France

Location

AP-HM - Hôpital Nord

Marseille, France, 13915, France

Location

Hôpital Privé Jacques Cartier

Massy, France, 91300, France

Location

GHI le Raincy Montfermeil

Montfermeil, France, 93370, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, France, 34295, France

Location

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, France, 34295, France

Location

CHU de Nantes

Nantes, France, 44000, France

Location

Clinique Ambroise Paré

Neuilly-sur-Seine, France, 45100, France

Location

CHR d'Orléans

Orléans, France, 45100, France

Location

APHP Hôpital Saint-Louis

Paris, France, 75010, France

Location

APHP Hôpital Cochin

Paris, France, 75013, France

Location

APHP Hôpital La Pitié Salpêtrière

Paris, France, 75013, France

Location

APHP Hôpital Tenon

Paris, France, 75020, France

Location

APHP Hôpital Saint-Antoine

Paris, France, 75571, France

Location

CHI Poissy

Poissy, France, 78300, France

Location

CH René Dubos

Pontoise, France, 95300, France

Location

CH de Saint-Lô

Saint-Lô, France, 50000, France

Location

CH de Saint-Nazaire

Saint-Nazaire, France, 44600, France

Location

Hôpital du Pays Salonais

Salon-de-Provence, France, 13300, France

Location

CH de Bassin de Thau

Sète, France, 34200, France

Location

CH de Saint-Malo

St-Malo, France, 35403, France

Location

Hôpital Foch

Suresnes, France, 92150, France

Location

CH de Tourcoing - Hôpital Guy Chatiliez

Tourcoing, France, 59208, France

Location

Ch Bretagne Atlantique - site de Vannes

Vannes, France, 59300, France

Location

CH de Vichy

Vichy, France, 03200, France

Location

Institut Gustave Roussy

Villejuif, France, 94805, France

Location

CHU La Guadeloupe

Pointe-à-Pitre, France, 97110, Guadeloupe

Location

Biospecimen

Retention: SAMPLES WITH DNA

Objective: to identify biomarkers of PTSD in family members of patients admitted to the ICU * Number of family members: 350 * Samples : 4 blood tubes (for DNA, RNA and plasma): total of 19 ml.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Jean REIGNIER, PU-PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 18, 2022
• Study Start: December 15, 2022
• Primary Completion: January 30, 2024
• Study Completion: September 13, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

FR (55); GU (1)