Study of the Social and Psychological Consequences of ICU Hospitalization

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Units
• Intervention / Treatment: Behavioral: phone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stay

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Paris, Ile de France, France, 75014
      • Groupe hospitalier Paris saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of Life quality with SP 36 questionnary	Only the first two questions of the SF-36 are used exploring the felt quality of life at the time of the telephone call and in comparison with the period before hospitalization in intensive care.	Day 0 at the end of hospitalization, 6 months after hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress Assessment Questionnaire posttraumatic	Stress Assessment Questionnaire posttraumatic (Revised Impact of Event Scale, IES-R)	Day 0 at the end of hospitalization, 6 months after hospitalization
Assessment of independence in activities of daily life	ADL: Assessment of independence in activities of daily life	Day 0 at the end of hospitalization, 6 months after hospitalization

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: GARROUSTE Maite, MD, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2014
• Primary Completion (Actual): May 30, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: SEPPICC