Improving FAMily Members' Experience in the ICU (FAME)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Family Members; Stress Disorders, Post-Traumatic

Treatments: Other: Family members of patients admitted to the ICU; Other: Patients; Other: Health care professionals

Study type: Observational

Funder types: Other

Identifiers

NCT05461521

RC22_0078

Details and patient eligibility

About

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.

Enrollment: 1,346 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,346 participants in 3 patient groups

Family members of patients admitted to the ICU

Treatment:

Other: Family members of patients admitted to the ICU

Health care professionals

Treatment:

Other: Health care professionals

Patients

Treatment:

Other: Patients