Improving FAMily Members' Experience in the ICU

NCT05461521 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1346

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

  • Stress Disorders, Post-Traumatic
  • Family Members

Interventions

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.

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).

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)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER
  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER
  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Jean REIGNIER, PU-PH · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2024-01-30
Completion
2024-09-13

Countries

  • France
  • Guadeloupe

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05461521 on ClinicalTrials.gov