Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit

Study Overview
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Brief Summary
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A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name post intensive care syndrome or PICS. Numerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit. All patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU. One month after discharge from the ICU, the patients will be randomly assigned to either in the intervention group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit or in the control group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.

Official Title
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Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit

Conditions
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Post Intensive Care Syndrome

Intervention / Treatment
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* Other: Psychological and quality of life questionnaires
* Other: Interdisciplinary consultation at 4/5 months


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Person who has given oral consent Patient 18 years of age or older Patient with at least one organ failure Patient with a stay of 6 days or more Exclusion Criteria: Person who is not affiliated or not a beneficiary of a social security system Patient at the end of his/her life Patient who does not speak French Minor (< 18 years old) Person subject to a legal protection measure (curatorship, guardianship) Person subject to a legal protection measure Pregnant, parturient or breastfeeding women Patient incarcerated Patient with a psychiatric history

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU<br> | Other: Psychological and quality of life questionnaires<br>* At 4/5 months and at 9 months<br>Other: Interdisciplinary consultation at 4/5 months<br>* About ten days after the questionnaires were administered<br>|
| Active Comparator: Patient managed under standard practice conditions<br> | Other: Psychological and quality of life questionnaires<br>* At 4/5 months and at 9 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOS SF-36 Quality of Life Scale Score |  | Between 4/5 and 9 months after discharge from intensive care |