Clinical trial NCT01796509: Study in Intensive Care Follow-up Programme in Improving Long-term Outcomes of ICU Survivors
Official title: Multicenter Randomised, Controlled Trial of a Intensive Care Follow -up Programme in Improving Long-term Outcomes of ICU Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Post ICU Discharge
Keywords: Quality of life,
Sequela disorders,
Socio-professional impact,
Anxiety, depression,
Post traumatic stress disorder,
ICU acquired paresis.
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Death or severe alteration of quality of life assessed after ICU discharge
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of life quality in Medical domain
timeFrame: 1 year
measure: Assessment in psychological domain
timeFrame: 1 year
measure: Assessment in social domain
timeFrame: 1 year
measure: Assessment in economical cost
timeFrame: 1 year
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
state: Ile De France
Study officials:
affiliation: ICU, Hôpital Raymond Poincaré
name: Tarek Sharshar, MD, PHD
role: STUDY_DIRECTOR
affiliation: ICU, Hôpital Raymond Poincaré
name: Diane Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedman D, Grimaldi L, Cariou A, Aegerter P, Gaudry S, Ben Salah A, Oueslati H, Megarbane B, Meunier-Beillard N, Quenot JP, Schwebel C, Jacob L, Robin Lagandre S, Kalfon P, Sonneville R, Siami S, Mazeraud A, Sharshar T. Impact of a Postintensive Care Unit Multidisciplinary Follow-up on the Quality of Life (SUIVI-REA): Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2022 May 9;11(5):e30496. doi: 10.2196/30496.