Clinical trial NCT02819154: Study of the Social and Psychological Consequences of ICU Hospitalization
Official title: Study of the Social and Psychological Consequences of ICU Hospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Units
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted in ICU and who had at least one organ dysfunction (need at least 24 hours of mechanical ventilation) in two intensive care units

Brief summary: Patients are admitted to intensive care for serious diseases (sepsis, ARDS ...) burdened with a high mortality rate. Invasive methods of resuscitation and the diseases treated can lead to serious sequelae. Follow-up studies of patients at hospital discharge report most often the quality of life using validated quantitative scales. A recent consensus of the American Society of resuscitation an update on the physical, cognitive and psychological sequelae of ICU hospitalization for the family and the patient, grouped under the term "post-intensive care syndrome." Social changes, emotional and professional are little studied and are not part of the information provided by the quality of life questionnaires. The investigators hypothesize that intensive care stay entails a profound effect on the lives of patients. This study will add additional data on a little known aspect of post resuscitation.

Detailed description: Primary objective :

To evaluate the social changes, emotional, professional a cohort of patients following ICU stay

Secondary objective:

Evaluate post traumatic stress disorder and quality of life of a cohort of patients following ICU stay

Methods :

Study design Study of bi-center cohort (ICUs of Saint Joseph and Bichat hospitals).

prospective follow the consequences of the intensive use of patient already included in the Outcomerea database using quality of life questionnaires, independence and post-traumatic stress and a questionnaire constructed for the study.

Patient selection in the database The database contains more than 10,000 visits. Investigators will select the patients in the two hospitals in the study. Then a second selection will be based on the inclusion criteria. The review of hospital records will not include patients with the first five criteria for non-inclusion. These patients appear in the flow chart

Eligibility criteria: Inclusion Criteria:

* Patient admitted in ICU and who had at least one organ dysfunction (need at least 24 hours of mechanical ventilation) in two intensive care units

Exclusion Criteria:

* Patient Do not speak French
* Patient aphasic deaf
* Patient with xxistencing cognitive disorders
* Homeless

Primary outcomes:
measure: Assessment of change of Life quality with SP 36 questionnary
timeFrame: Day 0 at the end of hospitalization, 6 months after hospitalization
Secondary outcomes:
measure: Stress Assessment Questionnaire posttraumatic
timeFrame: Day 0 at the end of hospitalization, 6 months after hospitalization
measure: Assessment of independence in activities of daily life
timeFrame: Day 0 at the end of hospitalization, 6 months after hospitalization
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile de France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: GARROUSTE Maite, MD
role: PRINCIPAL_INVESTIGATOR
References: