Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit
France404 participantsStarted 2023-02-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on quality of life after an ICU stay using something called the MOS SF-36 scale — can you explain what that scale actually measures and how it would track my recovery over time?
2Since this study is specifically about Post Intensive Care Syndrome, can you help me understand whether what I'm experiencing after my ICU stay matches what this trial is designed to address?
3The trial involves an 'interdisciplinary consultation system' after resuscitation — can you walk me through what that would actually look like for me in practice, like how many appointments, with which types of specialists, and over what period of time?
4This trial is listed as Phase NA, which I understand often applies to studies testing care systems rather than drugs — does that change what's known about the risks or benefits compared to a standard drug trial, and what would I be giving up or gaining compared to my current follow-up care?
5Are there other standard rehabilitation or follow-up programs for Post Intensive Care Syndrome already available to me that I should consider before deciding whether enrolling in this study makes sense?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MOS SF-36 Quality of Life Scale Score
Timeframe: Between 4/5 and 9 months after discharge from intensive care