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

NCT05625867 | Recruiting

• 1 other identifier: LAURENT UB 2022
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Intensive Care Syndrome

Outcome Measures

Primary Outcomes (1)

• MOS SF-36 Quality of Life Scale Score

  Between 4/5 and 9 months after discharge from intensive care

Study Arms (2)

Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU

EXPERIMENTAL

Other: Psychological and quality of life questionnaires; Other: Interdisciplinary consultation at 4/5 months

Patient managed under standard practice conditions

ACTIVE COMPARATOR

Other: Psychological and quality of life questionnaires

Interventions

Psychological and quality of life questionnaires OTHER

At 4/5 months and at 9 months

Patient managed under standard practice conditions; Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU

Interdisciplinary consultation at 4/5 months OTHER

About ten days after the questionnaires were administered

Post-resuscitation interdisciplinary consultation at 4/5 months after discharge from the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

postintensive care syndrome

Central Study Contacts

Alexandra LAURENT

CONTACT

03 80 39 39 77; alexandra.laurent@u-bourgogne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: February 5, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)