BACKGROUND
Critically ill patients are at risk of developing a post-intensive care syndrome (PICS), which is characterized by physical, psychological, and cognitive impairments and which dramatically impacts the patient’s quality of life (QoL). No intervention has been shown to improve QoL.
OBJECTIVE
We hypothesized that a medical, psychological and social follow-up would improve QoL by mitigating the PICS.
METHODS
We conducted a multicenter, randomized controlled trial (SUIVI-REA) comparing a multidisciplinary to a standard post-Intensive Care Unit (ICU) follow-up. In the intervention arm, multidisciplinary follow-up involved medical, psychological, and social evaluation at ICU discharge and at 3, 6 and 12 months thereafter. In the placebo group, patients were seen only at 12 months by the multidisciplinary team. Baseline characteristics at ICU discharge were collected for all patients. The primary outcome was QoL at one year, assessed using the EuroQoL 5 dimensions (EQ5D). Secondary outcomes were mortality, cognitive, psychological, and functional status, social and professional re-integration, and the rate of re-hospitalization and outpatient consultations at one year.
RESULTS
The study was funded by the Ministry of Health in June 2010. It was approved by the Ethics Committee on 08/07/2011. The first and last patient was randomized on 20/12/2012 and 01/09/2017, respectively. 546 patients were enrolled across 11 ICUs. At present, data management is ongoing, and all parties involved in the trial remain blinded.
CONCLUSIONS
The SUVI-REA multicenter randomized controlled trial aims to assess whether a post-ICU multidisciplinary follow-up improves QoL at one year.
CLINICALTRIAL
Clinicaltrials.gov identifier NCT01796509 (registered on 21/02/2013).