JMIR Publications

ABSTRACT

Introduction: Critically ill patients are at risk to develop a Post-Intensive Care Syndrome (PICS), which is characterized by physical, psychological and cognitive impairments and dramatically impacts the quality of life. No intervention has been shown to improve the quality of life (QoL). Because of the interdependency of its domains, we hypothesized that a medical, psychological and social follow-up would improve the QoL by mitigating the PICS. Methods and analysis: We conducted a multicenter, double-blind, randomized controlled trial comparing a multidisciplinary to a standard post-ICU follow-up. In the intervention arm, multidisciplinary follow-up consisted of medical, psychological and social evaluation at ICU discharge and at 3, 6 and 12 months after ICU discharge. In the placebo group, patients were seen only at 12 months by the multidisciplinary team. The baseline characteristics at ICU discharge were collected in all patients. The primary outcome was the quality of life at one year, assessed with help of EuroQoL 5 dimensions (EQ5D). Secondary outcomes were mortality, cognitive, psychological and functional status, the social and professional reintegration as well as the rate of re-hospitalization and outpatient consultations at one year. The first patient was randomized on 20/12/2012 and the last patient on 01/09/2017 out of 546 patients who were enrolled across 11 ICUs. At present, data management is still ongoing, and all parties involved in the trial remain blinded. Ethics and dissemination – Research Ethics Committee of Saint-Germain-en-Laye, France, initial approval received on 08/07/2011. Results will be disseminated via peer-reviewed publication and presentation at international conferences. Trial registration: Clinicaltrials.gov identifier NCT01796509 (registered on 21/02/2013).