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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Post ICU Discharge; Quality of Life

Treatments: Other: Medical, psychological, social

Study type: Interventional

Funder types: Other

Identifiers

NCT01796509

P100147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 545 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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545 participants in 2 patient groups

multidisciplinary follow-up

Experimental group

Treatment:

Other: Medical, psychological, social

no follow-up

No Intervention group