All studies
RecruitingNAINTERVENTIONAL

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

Staying in intensive care (ICU) can sometimes lead to difficulties like severe tiredness, memory problems, anxiety, or feeling down, which doctors call Post Intensive Care Syndrome (PICS). This study wants to find out if having a follow-up consultation with a team of different healthcare professionals a few months after leaving the ICU can help patients feel better and improve their quality of life. Many patients experience PICS, but there isn't always enough support afterwards. Researchers will follow patients for nine months, with some receiving this special consultation and others not. All participants will complete questionnaires to help understand if this extra support makes a positive difference to their recovery.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre Hospitalier Universitaire Dijon
Enrolment target
404
Start
05 Feb 2023
Estimated completion
01 May 2026

What is this study about?

When someone has been very unwell and spent time in an intensive care unit (ICU), it's common for them to experience lingering problems afterwards. These can include things like severe tiredness, muscle weakness, memory and concentration issues, or emotional challenges like anxiety, depression, or even post-traumatic stress disorder (PTSD). Doctors refer to this collection of problems as Post Intensive Care Syndrome, or PICS.

While many people experience PICS, there isn't always a structured way to support them once they leave the hospital. This study is designed to see if a special follow-up appointment, called an "interdisciplinary consultation," can make a real difference. An interdisciplinary consultation means you would meet with a team of different healthcare professionals (like a doctor, nurse, and possibly others) who work together to understand your recovery and offer advice and support after your ICU stay.

Researchers want to understand if having this type of consultation around four to five months after leaving the ICU can improve patients' quality of life. They will compare patients who have this consultation with those who receive standard care, using questionnaires to measure how people are feeling and how well they are doing up to nine months after their ICU discharge. This study is important because it could help improve how we support people recovering from severe illness.

Key takeaways

  • Looks at supporting patients after severe illness.
  • Focuses on improving quality of life after ICU.
  • Tests a special follow-up consultation with a team of experts.
  • Involves answering questionnaires about how you're feeling.
  • Aims to help future patients recover better.
  • Participation lasts for 9 months after leaving ICU.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have spent at least six days in an intensive care unit because of a serious illness that affected at least one of your body's main organs.

There are some reasons why you wouldn't be able to join. For example, if you are not covered by a social security system, are nearing the end of your life, or do not speak French, you wouldn't be eligible. Also, if you are pregnant or breastfeeding, incarcerated, or have a history of mental health conditions, you wouldn't be able to take part. The study also cannot include individuals who are under guardianship or similar legal protection.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years or older?
  2. Did you stay in an intensive care unit (ICU) for at least 6 days?
  3. Did you have an illness affecting at least one organ during your ICU stay?
  4. Do you speak French?
  5. Do you not have a history of mental health conditions?
  6. Are you not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be followed for nine months after you leave the intensive care unit (ICU). About one month after discharge, you'll be randomly assigned to one of two groups. One group will have a special follow-up appointment with a team of healthcare professionals around four to five months after leaving the ICU. The other group will not have this specific follow-up consultation but will receive usual care.

Regardless of which group you're in, you will be asked to complete some questionnaires about your psychological well-being and quality of life. These questionnaires will be completed by phone or online at two main points: around four to five months after your ICU discharge, and again at nine months. There are no medications involved in this study, and the overall time commitment for filling out questionnaires is relatively small.

Potential risks and benefits

Taking part in this study might help improve our understanding of how best to support patients after an ICU stay, potentially benefiting future patients. If you are in the group that receives the interdisciplinary consultation, you may personally benefit from the advice and support offered. The main 'risk' is the time commitment for completing the questionnaires. You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

  • Chu Dijon Bourgogne
    Verified postcode
    Dijon, France· Recruiting

Common questions

What is Post Intensive Care Syndrome (PICS)?

PICS refers to problems like weakness, memory issues, anxiety, or depression that can happen after a serious illness and a stay in intensive care.

Who can join this study?

You need to be over 18, have stayed at least 6 days in ICU due to organ failure, and speak French. There are a few other specific criteria too.

What does 'interdisciplinary consultation' mean?

It means you'd meet with a team of different healthcare professionals who work together to help with your recovery after the ICU.

Will I have to take new medicine?

No, this study does not involve any new medications. It's about a follow-up consultation and questionnaires.

How long will the study last for me?

You'll be followed for 9 months after you leave the ICU, with questionnaires at two points during that time.

How to find out more

Alexandra LAURENT

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Post-Resuscitation Interdisciplinary Consultation System: a …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.