Study in Intensive Care Follow-up Programme in Improving Long-term Outcomes of ICU Survivors — SUIVI-REA  

Quality of Life Clinical Trial

Official title: Multicenter Randomised, Controlled Trial of a Intensive Care Follow -up Programme in Improving Long-term Outcomes of ICU Survivors

Status Completed

Clinical Trial Summary

Study Hypothesis:

Critical illness is associated with long-term medical and psychological sequelae that can impact the professional and private life. The purpose of the present multicenter randomized controlled trial is to assess whether or not a medical, psychological and social follow-up improves quality of life of critically ill patients at one year after their discharge from intensive care unit (ICU).

Primary Purpose:

Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.

Clinical Trial Description

Critically ill patients who had required at least 3 days of mechanical ventilation and who consented to participate will be randomized at time of ICU discharge in either follow-up or not follow-up arm. The medical, psychological and social follow-up consists of multidisciplinary consultation at time of ICU discharge (i.e. inclusion), at three, six and 12 months afterward. Patients of the "non follow-up group" will be seen only at one year. Medical consultation will be focused on evaluation of pre-existing co-morbidities, detection of new ones and of physical disorders related to critical illness (i.e. ICU-acquired paresis, pain, functional disability, cognitive dysfunction…). Psychological assessment will be focused on detection of anxiety, depression and post-traumatic stress syndrome. Social follow-up will assess the social need of the patient in the professional and private domains. Each assessment will be standardized by using validated or appropriate scores. At the end of each multidisciplinary consultation, a report will be sent to the patient and his general practitioner. When necessary, a consultation with a specialist will be organized. At one year, an observer blinded from randomization will call all the patients to assess their quality of life with help of EQ5D questionnaire. Economical cost of multidisciplinary follow-up will be assessed.

To our knowledge, there is no follow-up studies that have combined a medical, psychological and social cares. For instance, the PracTical study has not evidenced an improvement of quality of life in patients who had beneficiated from nurse consultations at 3 and 9 months. ;

Related Conditions & MeSH terms

• Post ICU Discharge
• Quality of Life

• NCT number: NCT01796509
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Completion date: March 11, 2020