An interventional study of Medical, psychological, social in Quality of Life and Post ICU Discharge, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
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.
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Other: Medical, psychological, social
After having given his consent, the patient filled auto questionnaire, and then randomized either in follow up arm (i.e. intervention group) or in no follow up arm (i.e. control group). In the follow up arm, medical, psychological and social consultation will be planned within the first seven days after inclusion, and then 3, 6, 12 months. During medical consultation a general examination will be performed, muscle strength, cognitive function, functional disabilities will be assessed with help of MRC, MMS. During psychological consultation, anxiety and depression will be assessed with the help of HAD, IES. The psychologist will also have a free interview. During social consultation personal and professional reinsertion will be assessed.
Death or severe alteration of quality of life assessed after ICU discharge
Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.
Time frame: 1 year
Assessment of life quality in Medical domain
ICU-acquired paresis assessed with help of MRC sum score, Functional disabilities assessed with help of Barthel and IADL scales, Cognitive dysfunctions assessed with help of MMS score, Pain, Comorbidities (Hypertension, etc...).
Time frame: 1 year
Assessment in psychological domain
Anxiety assessed with help of HAD scale, Depression assessed with help of HAD scale Post-traumatic stress syndrome assessed with help of IES scale.
Time frame: 1 year
Assessment in social domain
Social reinsertion with help of RNLI scale.
Time frame: 1 year
Assessment in economical cost
Number of hospitalization,number of outpatient consultation and prescription of new treatment will be assessed within 1 year.
Time frame: 1 year
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris