Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychological and quality of life questionnaires, Interdisciplinary consultation at 4/5 months.
- Who it may be relevant to
- Registry conditions: Post Intensive Care Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Psychological and quality of life questionnaires
At 4/5 months and at 9 months - Other Interdisciplinary consultation at 4/5 months
About ten days after the questionnaires were administered
Primary outcome measures
- MOS SF-36 Quality of Life Scale Score [Time frame: Between 4/5 and 9 months after discharge from intensive care]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- Chu Dijon Bourgogne — Dijon
Identifiers
NCT: NCT05625867 · LAURENT UB 2022