Improving FAMily Members' Experience in the ICU
Key facts
- Who runs it
- Nantes University Hospital
- Where
- France and Guadeloupe56 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 1,346 people enrolled
- Started
- 15 Dec 2022
- Ended
- 13 Sept 2024
- Type of study
- Observational, 3 groups
- Treatments tested
- Family members of patients admitted to the ICU
- Health care professionals
- Patients
- Record updated
- 1 October 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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
Who cannot take part
- Unable to communicate on the phone (hearing impairment...); Service Professionals:
- 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
- Not on duty (locum tenens or interim team, only on-call) on call)
- Not qualified (Physician: at least intern, nurse DE)
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The 3 groups in the trial
- Family members of patients admitted to the ICU
- Health care professionals
- Patients
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Post-traumatic Stress Disorder in Relatives of Patients Admitted to the ICU: a Multicenter, Observational, Prospective Study (FAME Observational)
- Record updated
- 1 October 2024