Improving FAMily Members' Experience in the ICU

Stress Disorders, Post-Traumatic Clinical Trial

— FAME  

Official title:

Post-traumatic Stress Disorder in Relatives of Patients Admitted to the ICU: a Multicenter, Observational, Prospective Study (FAME Observational)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05461521
• Other study ID #: RC22_0078
• Status: Active, not recruiting
• Start date: December 15, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1346
• Est. completion date: July 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Family Members
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	CH Angoulême	Angoulême
France	Hôpital Privé d'Antony	Antony
France	CH d'Argenteuil	Argenteuil
France	CH de Bastia	Bastia
France	CH Beauvais	Beauvais
France	Hôpital Nord Franche Comté	Belfort
France	CH de Béthune	Beuvry
France	APHP Hôpital Avicenne	Bobigny
France	CHU de Bordeaux - Hôpital Pellegrin	Bordeaux
France	CHU de Bordeaux - Hôpital Saint-André	Bordeaux
France	AP-HP Hôpital Ambroise Paré	Boulogne
France	CH de Boulogne-sur-Mer	Boulogne-sur-Mer
France	CHU de Brest	Brest
France	CH de Chartres	Chartres
France	CH de Cholet	Cholet
France	CHU Clermont-Ferrand - Centre Jean Perrin	Clermont-Ferrand
France	CHU Clermont-Ferrand - Hôpital Gabriel Montpied	Clermont-Ferrand
France	CH de Dieppe	Dieppe
France	CHU de Dijon	Dijon
France	CH de Fréjus - Saint Raphaël	Fréjus
France	APHP Hôpital Raymond Poincaré	Garches
France	CHU de Grenoble Alpes	Grenoble
France	GHEF- Site de Marne de la Vallée	Jossigny
France	CHD Vendée	La Roche-sur-Yon
France	CH de la Rochelle	La Rochelle
France	CH Versailles - Hôpital André Mignot	Le Chesnay
France	CH du Mans	Le Mans
France	CHU de Lille - Hôpital Roger Salengro	Lille
France	GHB Sud - Hôpital de Lorient	Lorient
France	CHU De Lyon - Hôpital Edouard Herriot	Lyon
France	AP-HM - Hôpital Nord	Marseille
France	Hôpital Privé Jacques Cartier	Massy
France	GHI le Raincy Montfermeil	Montfermeil
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Montpellier - Hôpital Saint-Eloi	Montpellier
France	CHU de Nantes	Nantes
France	Clinique Ambroise Paré	Neuilly-sur-Seine
France	CHR d'Orléans	Orléans
France	APHP Hôpital Cochin	Paris
France	APHP Hôpital La Pitié Salpêtrière	Paris
France	APHP Hôpital Saint-Antoine	Paris
France	APHP Hôpital Saint-Louis	Paris
France	APHP Hôpital Tenon	Paris
France	CHI Poissy	Poissy
France	CH René Dubos	Pontoise
France	CH de Saint-Lô	Saint-Lô
France	CH de Saint-Malo	Saint-Malo
France	CH de Saint-Nazaire	Saint-Nazaire
France	Hôpital du Pays Salonais	Salon-de-Provence
France	CH de Bassin de Thau	Sète
France	Hôpital Foch	Suresnes
France	CH de Tourcoing - Hôpital Guy Chatiliez	Tourcoing
France	Ch Bretagne Atlantique - site de Vannes	Vannes
France	CH de Vichy	Vichy
France	Institut Gustave Roussy	Villejuif
Guadeloupe	CHU La Guadeloupe	Pointe-à-Pitre	France

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Assistance Publique - Hôpitaux de Paris, Assistance Publique Hopitaux De Marseille

Countries where clinical trial is conducted

France,  Guadeloupe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative study	To deepen the understanding of the mechanisms leading to post-traumatic stress disorder in relatives of patients admitted to the ICU; Semi-structured interviews conducted by a psychologist or a sociologist; Population concerned by the interviews: relatives of non deceased patients (n= 20); bereaved relatives (patient who died in intensive care) (n= 20); nurses (n= 20) and intensive care physicians (n= 20).	3 to 4 months after the patient's death or discharge of the patient from the intensive care unit
Other	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 : Maslach Burnout Inventory (MBI) for the assessment of burnout; Job Content Questionnaire (JCQ) for the assessment of job stress months").; Ethical Decision-Making Climate Questionnaire (EDMCQ) for the evaluation of the ethical climate; Professional Quality Of Life scale (ProQOL) for the assessment of quality of life at work; Connor-Davidson Resilience scale (CD-RISC 10) to assess resilience; Cultural Awareness Scale (CAS)	at the beginning of the study in the department
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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