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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05625867
Collaborator
(none)
256
2
21

Study Details

Study Description

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 3 months after their discharge from the intensive care unit

  • or in the "control" group without post resuscitation consultation. They will all be contacted at 3 and 9 months to complete psychological and quality of life questionnaires.

Condition or Disease Intervention/Treatment Phase
  • Other: Psychological and quality of life questionnaires
  • Other: Interdisciplinary consultation at 3 months
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
256 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Post-resuscitation interdisciplinary consultation at 3 months after discharge from the ICU

Other: Psychological and quality of life questionnaires
At 3 months and at 9 months

Other: Interdisciplinary consultation at 3 months
About ten days after the questionnaires were administered

Active Comparator: Patient managed under standard practice conditions

Other: Psychological and quality of life questionnaires
At 3 months and at 9 months

Outcome Measures

Primary Outcome Measures

  1. MOS SF-36 Quality of Life Scale Score [Between 3 and 9 months after discharge from intensive care]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT05625867
Other Study ID Numbers:
  • LAURENT UB 2022
First Posted:
Nov 23, 2022
Last Update Posted:
Nov 23, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 23, 2022