Background: Older patients raise therapeutic challenges, as they constitute a heterogeneous population with multimorbidity. To appraise complexity, geriatricians developed a multidimensional geriatric assessment (GA) which may prove difficult to apply in primary care settings. Our primary objective is to compare to usual care the effect on morbi-mortality of two complex interventions combining educational seminars about GA, a dedicated geriatric hotline for general practitioners (GPs), and conduction of GA either by trained nurses or GPs. .
Methods and Analysis: The CEPIA study is an open-label, pragmatic, multicentre, three-arm, cluster randomised, controlled trial to compare two intervention groups and one control group. Patients must be aged 70 years or older with a long-term illness scheme or with unscheduled hospitalization in the past three months (750 patients planned). This study will involve volunteering GPs practicing in French primary care centres, with randomization at practice level. The multifaceted interventions for interventional arms comprise an educational interactive multi-professional seminar for GPs and nurses, a geriatric hotline dedicated to GPs in case of difficulties, and the performance of a GA updated to primary care. The GA will be systematically performed by a nurse in arm 1, whereas GA will be GP-led on a case-by-case basis in arm 2. The primary endpoint is a composite comprising overall death, unscheduled hospitalizations, emergency admissions, and institutionalization within 12 months after inclusion.. Intention-to-treat analysis will be performed using mixed-effects logistic regression models, with adjustment for potential confounders.
Ethics and dissemination: The protocol was approved by appropriate ethics committee [CPP Ile-de-France IV, Paris, France, approval April, 2015;15 664]. This study will be 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 GA in primary care.
Trial registration number: NCT02664454; Pre-results.
Trial status: A total of 88 GPs from 40 practices agreed to participate in the study and were randomized to one of the three study arms on 21 december 2015. Educational seminars took place on 21may 2016, 2 and 3 June 2016 involving a total 70 participants of whom 58 were GP from intervention arms #1 and #2 and 12 were nurses from arm #1. The first patient was included on 24 may of 2016. The study is ongoing.