Friedman Diane, Grimaldi Lamiae, Cariou Alain, Aegerter Philippe, Gaudry Stéphane, Ben Salah Abdel, Oueslati Haikel, Megarbane Bruno, Meunier-Beillard Nicolas, Quenot Jean-Pierre, Schwebel Carole, Jacob Laurent, Robin Lagandré Ségloène, Kalfon Pierre, Sonneville Romain, Siami Shidasp, Mazeraud Aurelien, Sharshar Tarek
Raymond Poincaré Hospital, Versailles Saint-Quentin-en-Yvelines, Garches, France.
U1018 Université Versailles, Saint Quentin en Yvelines-INSERM Unité 1018, Groupe Interrégional de Recherche Clinique er d'Innovation, Île-de-France, France.
JMIR Res Protoc. 2022 May 9;11(5):e30496. doi: 10.2196/30496.
Critically ill patients are at risk of developing a postintensive 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. We hypothesized that a medical, psychological, and social follow-up would improve QoL by mitigating the PICS.
This multicenter, randomized controlled trial (SUIVI-REA) aims to compare a multidisciplinary follow-up with a standard postintensive care unit (ICU) follow-up.
Patients were randomized to the control or intervention arm. 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 1 year, assessed using the Euro Quality of Life-5 dimensions (EQ5D). Secondary outcomes were mortality, cognitive, psychological, and functional status; social and professional reintegration; and the rate of rehospitalization and outpatient consultations at 1 year.
The study was funded by the Ministry of Health in June 2010. It was approved by the Ethics Committee on July 8, 2011. The first and last patient were randomized on December 20, 2012, and September 1, 2017, respectively. A total of 546 patients were enrolled across 11 ICUs. At present, data management is ongoing, and all parties involved in the trial remain blinded.
The SUVI-REA multicenter randomized controlled trial aims to assess whether a post-ICU multidisciplinary follow-up improves QoL at 1 year.
Clinicaltrials.gov NCT01796509; https://clinicaltrials.gov/ct2/show/NCT01796509.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30496.
危重症患者有发生重症监护后综合征（PICS）的风险，其特征为身体、心理和认知障碍，这会显著影响患者的生活质量（QoL）。目前尚无干预措施可改善生活质量。我们假设，医疗、心理和社会随访可通过减轻PICS来改善生活质量。
这项多中心随机对照试验（SUIVI - REA）旨在比较多学科随访与重症监护病房（ICU）标准随访的效果。
患者被随机分配至对照组或干预组。在干预组中，多学科随访包括在ICU出院时以及此后3个月、6个月和12个月进行医疗、心理和社会评估。在安慰剂组中，多学科团队仅在12个月时对患者进行检查。收集所有患者在ICU出院时的基线特征。主要结局是1年时的生活质量，采用欧洲五维健康量表（EQ5D）进行评估。次要结局包括死亡率、认知、心理和功能状态；社会和职业重新融入；以及1年时的再住院率和门诊就诊率。
该研究于2010年6月由卫生部资助。2011年7月8日获得伦理委员会批准。首例和末例患者分别于2012年12月20日和2017年9月1日被随机分组。共有546例患者纳入11个ICU。目前，数据管理正在进行中，试验涉及的所有各方仍处于盲态。
SUIVI - REA多中心随机对照试验旨在评估ICU后的多学科随访是否能改善1年时的生活质量。
Clinicaltrials.gov NCT01796509；https://clinicaltrials.gov/ct2/show/NCT01796509。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/30496。
