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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 404
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra LAURENT; Phone Number: 03 80 39 39 77; Email: alexandra.laurent@u-bourgogne.fr

Study Locations

• France
  • Dijon, France
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Alexandra LAURENT; Phone Number: 03 80 39 39 77; Email: alexandra.laurent@u-bourgogne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient managed under standard practice conditions	Other: Psychological and quality of life questionnaires; At 4/5 months and at 9 months
Experimental: Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LAURENT UB 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No