Ferrat Emilie, Bastuji-Garin Sylvie, Paillaud Elena, Caillet Philippe, Clerc Pascal, Moscova Laura, Gouja Amel, Renard Vincent, Attali Claude, Breton Julien Le, Audureau Etienne
Université Paris-EstCréteil (UPEC), DHU A-TVB, IMRB, EA 7376 CEpiA (Clinical Epidemiology andAgeing Unit), Créteil, France.
Université Paris-Est Créteil (UPEC), School ofMedicine, Primary Care Department, Créteil, France.
BMJ Open. 2018 Apr 12;8(4):e020597. doi: 10.1136/bmjopen-2017-020597.
Older patients raise therapeutic challenges, because they constitute a heterogeneous population with multimorbidity. To appraise this complexity, geriatricians have developed a multidimensional comprehensive geriatric assessment (CGA), which may be difficult to apply in primary care settings. Our primary objective was to compare the effect on morbimortality of usual care compared with two complex interventions combining educational seminars about CGA: a dedicated geriatric hotline for general practitioners (GPs) and CGA by trained nurses or GPs.
The Clinical Epidemiology and Ageing study is an open-label, pragmatic, multicentre, three-arm, cluster randomised controlled trial comparing two intervention groups and one control group. Patients must be 70 years or older with a long-term illness or with unscheduled hospitalisation in the past 3 months (750 patients planned). This study involves volunteering GPs practising in French primary care centres, with randomisation at the practice level. The multifaceted interventions for interventional arms comprise an educational interactive multiprofessional seminar for GPs and nurses, a geriatric hotline dedicated to GPs in case of difficulties and the performance of a CGA updated to primary care. The CGA is systematically performed by a nurse in arm 1 but is GP-led on a case-by-case basis in arm 2. The primary endpoint is a composite criterion comprising overall death, unscheduled hospitalisations, emergency admissions and institutionalisation within 12 months after inclusion. Intention-to-treat analysis will be performed using mixed-effects logistic regression models, with adjustment for potential confounders.
The protocol was approved by an appropriate ethics committee (CPP Ile-de-France IV, Paris, France, approval April 2015;15 664). This study is conducted according to principles of good clinical practice in the context of current care and will provide useful knowledge on the clinical benefits achievable by CGA in primary care.
NCT02664454; Pre-results.
老年患者带来了治疗方面的挑战，因为他们是一个患有多种疾病的异质性群体。为评估这种复杂性，老年医学专家开发了多维综合老年评估（CGA），但在初级保健环境中可能难以应用。我们的主要目标是比较常规护理与两种复杂干预措施对疾病死亡率的影响，这两种复杂干预措施结合了关于CGA的教育研讨会：为全科医生（GP）设立的专门老年热线以及由经过培训的护士或GP进行的CGA。
临床流行病学与老龄化研究是一项开放标签、实用、多中心、三臂、整群随机对照试验，比较两个干预组和一个对照组。患者必须年满70岁，患有长期疾病或在过去3个月内有非计划住院（计划纳入750名患者）。本研究涉及在法国初级保健中心执业的志愿全科医生，在诊所层面进行随机分组。干预组的多方面干预措施包括为全科医生和护士举办的教育互动多专业研讨会、在遇到困难时为全科医生设立的老年热线以及适用于初级保健的更新后的CGA。在第1组中，CGA由护士系统地进行，但在第2组中，由全科医生根据具体情况主导。主要终点是一个综合标准，包括纳入后12个月内的全因死亡、非计划住院、急诊入院和机构化。将使用混合效应逻辑回归模型进行意向性分析，并对潜在混杂因素进行调整。
该方案已获得适当的伦理委员会批准（法国巴黎法兰西岛第四区保护个人委员会，批准时间为2015年4月；15 664）。本研究是在当前护理背景下按照良好临床实践原则进行的，将提供关于CGA在初级保健中可实现的临床益处的有用知识。
NCT02664454；预结果。
