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

Not Applicable

Recruiting

• Conditions: Post Intensive Care Syndrome
• Interventions: Other: Psychological and quality of life questionnaires; Other: Interdisciplinary consultation at 4/5 months

• Registration Number: NCT05625867
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Study Start: 2023-02-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient managed under standard practice conditions	Psychological and quality of life questionnaires	-
Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU	Psychological and quality of life questionnaires	-
Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU	Interdisciplinary consultation at 4/5 months	-

Primary Outcome Measures

Name	Time	Method
MOS SF-36 Quality of Life Scale Score	Between 4/5 and 9 months after discharge from intensive care

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France