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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Quality of Life, Post ICU Discharge

Intervention / Treatment
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* Other: Medical, psychological, social


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women older than 18 Living in an area near the hospital Hospitalized in the ICU medical surgical hospitals in this study. Who required mechanical ventilation more than 3 days Having a life expectancy greater than one year (Mc Cabe score >2, absence of metastatic cancer) Having a general practitioner identified Is affiliated to a social health care And who have given their written informed consent Exclusion Criteria: Patients hospitalized in ICU in the previous year Patients followed for a preexisting myopathy The burn patients, patients with brain injury (Glasgow initial <8) or trauma Patients hospitalized for suicide or self-induced poisoning Patients with psychiatric disorders Patients with ore dementia Pregnant women Patients who do not speak fluently French Patients with guardianship Homeless patients No having a general practitioner identified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multidisciplinary follow-up<br> | Other: Medical, psychological, social<br>* 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.<br>|
| No Intervention: no follow-up<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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…). | 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. | 1 year | 
| Assessment in social domain | Social reinsertion with help of RNLI scale. | 1 year | 
| Assessment in economical cost | Number of hospitalization,number of outpatient consultation and prescription of new treatment will be assessed within 1 year. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life,, Sequela disorders,, Socio-professional impact,, Anxiety, depression,, Post traumatic stress disorder,, ICU acquired paresis.