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Diane F, 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 Lagandré 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
DESIGN AND CONDUCT OF A MULTICENTER RANDOMIZED CLINICAL TRIAL ON THE IMPACT OF A POST-INTENSIVE CARE UNIT MULTIDISCIPLINARY FOLLOW-UP ON THE QUALITY OF LIFE (SUIVI-REA)
Friedman Diane;
Lamiae Grimaldi;
Alain Cariou;
Philippe Aegerter;
Stéphane Gaudry;
Abdel Ben Salah;
Haikel Oueslati;
Bruno Megarbane;
Nicolas Meunier-Beillard;
Jean-Pierre Quenot;
Carole Schwebel;
Laurent Jacob;
Ségloène Robin Lagandré;
Pierre Kalfon;
Romain Sonneville;
Shidasp Siami;
Aurelien Mazeraud;
Tarek Sharshar
ABSTRACT
Background:
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).
Objective:
We hypothesized that a medical, psychological and social follow-up would improve the QoL by mitigating the PICS.
Methods:
We conducted a multicenter, randomized controlled trial (SUIVI-REA) 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.
Result 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 were randomized on 20/12/2012 and 01/09/2017, respectively. 546 patients were enrolled across 11 ICUs. At present, data management is still ongoing, and all parties involved in the trial remain blinded.
Conclusion: The SUVI-REA multicenter randomized control trial aimed to assess whether a post-ICU multidisciplinary follow-up improves the quality of life at one year.
Trial registration: Clinicaltrials.gov identifier NCT01796509 (registered on 21/02/2013).
Citation
Please cite as:
Diane F, 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 Lagandré 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