Improving FAMily Members' Experience in the ICU (FAME)

March 29, 2024 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1346

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angoulême, France, 16000
      • Antony, France, 92160
      • Argenteuil, France, 95100
      • Bastia, France, 20600
      • Beauvais, France, 60000
      • Belfort, France, 90015
        • Hôpital Nord Franche Comté
        • Contact:
      • Beuvry, France, 62660
      • Bobigny, France, 9300
      • Bordeaux, France, 33076
      • Bordeaux, France, 33000
      • Boulogne, France, 92104
      • Boulogne-sur-Mer, France, 62231
        • CH de Boulogne-sur-Mer
      • Brest, France, 29609
      • Chartres, France, 28000
      • Cholet, France, 49300
      • Clermont-Ferrand, France, 63000
      • Clermont-Ferrand, France, 63003
      • Dieppe, France, 76200
        • CH de Dieppe
        • Contact:
      • Dijon, France, 21033
      • Fréjus, France, 83608
      • Garches, France, 92380
        • APHP Hôpital Raymond Poincaré
        • Contact:
      • Grenoble, France, 38043
      • Jossigny, France, 77600
        • GHEF- Site de Marne de la Vallée
      • La Roche-sur-Yon, France, 85000
      • La Rochelle, France, 17019
      • Le Chesnay, France, 78150
      • Le Mans, France, 72000
      • Lille, France, 59045
      • Lorient, France, 56322
        • GHB Sud - Hôpital de Lorient
        • Contact:
      • Lyon, France, 69437
        • CHU De Lyon - Hôpital Edouard Herriot
        • Contact:
      • Marseille, France, 13915
      • Massy, France, 91300
      • Montfermeil, France, 93370
      • Montpellier, France, 34295
      • Montpellier, France, 34295
      • Nantes, France, 44000
      • Neuilly-sur-Seine, France, 45100
        • Clinique Ambroise Paré
        • Contact:
      • Orléans, France, 45100
      • Paris, France, 75010
        • APHP Hôpital Saint-Louis
        • Contact:
      • Paris, France, 75013
        • APHP Hôpital Cochin
        • Contact:
      • Paris, France, 75013
        • APHP Hôpital La Pitié Salpétrière
        • Contact:
      • Paris, France, 75020
      • Paris, France, 75571
        • APHP Hôpital Saint-Antoine
        • Contact:
      • Poissy, France, 78300
      • Pontoise, France, 95300
      • Saint-Lô, France, 50000
      • Saint-Malo, France, 35403
      • Saint-Nazaire, France, 44600
      • Salon-de-Provence, France, 13300
      • Suresnes, France, 92150
      • Sète, France, 34200
      • Tourcoing, France, 59208
        • CH de Tourcoing - Hôpital Guy Chatiliez
        • Contact:
      • Vannes, France, 59300
      • Vichy, France, 03200
      • Villejuif, France, 94805
  • Guadeloupe
    • France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Other: 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)
Family members of patients admitted to the ICU
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
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the factors associated with post-traumatic stress disorder (PTSD) in family members of patients admitted to the ICU, and.
Time Frame: at 3 months after the patient's discharge from the ICU
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
Time Frame: at 3 months after the patient's discharge from the ICU
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the psychological impact of a family member stay in intensive care
Time Frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
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
Assessing the psychological impact of a family member stay in intensive care
Time Frame: 6 months after the patient's discharge from the ICU
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
Assessing the psychological impact of a family member stay in intensive care
Time Frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
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
Assessing the psychological impact of a family member stay in intensive care
Time Frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
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
Assessing the psychological impact of a family member stay in intensive care
Time Frame: at inclusion, at the patient's discharge from the ICU, 3 and 6 months after the patient's discharge from the ICU
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
Assessing the psychological impact of a family member stay in intensive care
Time Frame: at 6 months after the patient's death 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
To identify the impact on the consumption of care and medical procedures of PTSD in family members of patients admitted to the ICU
Time Frame: at 3 and 6 months after discharge of the patient from the intensive care unit
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative study
Time Frame: 3 to 4 months after the patient's death or discharge of the patient from the intensive care unit

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:

    1. relatives of non deceased patients (n= 20)
    2. bereaved relatives (patient who died in intensive care) (n= 20)
    3. 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
FAME ICU Team (FIT) study
Time Frame: at the beginning of the study in the department

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
FAME Bio-bank: Analysis of molecular signatures of PTSD
Time Frame: to the inclusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Assistance Publique - Hôpitaux de Paris
Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Jean REIGNIER, PU-PH, Nantes university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Actual)

January 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC22_0078

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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