Mandrioli Jessica, Santangelo Mario, Luciani Antonio, Toscani Stefano, Zucchi Elisabetta, Giovannini Giada, Martinelli Ilaria, Cecoli Sonia, Bigliardi Guido, Scanavini Sara, Meletti Stefano
Neurology Unit, Azienda Ospedaliero-Universitaria di Modena Ospedale Civile di Baggiovara, Modena, Italy.
Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
BMJ Open. 2021 May 19;11(5):e048293. doi: 10.1136/bmjopen-2020-048293.
The COVID-19 pandemic compelled health systems to protect patients and medical personnel during transit in hospitals by minimising transfers, prompting the use of telehealth systems. In the field of neurology, telemedicine has been used in emergency settings for acute stroke management between spoke and hub hospital networks, where good outcomes have been achieved. However, data on the use of telemedicine in non-stroke acute neurological conditions accessing the emergency department (ED) are currently missing.
This is an interventional, open-label trial on the use of teleconsultation in the ED for neurological diseases other than stroke. The study aims to develop a remote consultancy system (TeleNeurological Evaluation and Support, TeleNS) for patients with acute neurological symptoms referred to hospital facilities without a 24-hour availability of a neurologist consultant (spoke hospitals). The study population will include 100 ED patients referred to two spoke hospitals in 6 months, who will be asked to perform teleconsultation instead of inperson visits. As a control group, retrospectively available data from patients admitted to the ED of spoke hospitals during the same time period over the last 2 years will be evaluated. The primary objective is to assess whether a TeleNS for the ED guarantees a faster but qualitatively non-inferior diagnostic/therapeutic work-up if compared with inperson examination, assuring the availability of all the necessary examinations and treatments with consistent time-saving.
The trial was designed following the national guidelines on clinical investigation on telemedicine provided by the Italian Ministry of Health and according to the Standard Protocol Items for Randomized Trials statement guidelines. This research protocol was approved by Comitato Etico Area Vasta Emilia Nord in September 2020 (number/identification: 942/2020/DISP/AOUMO SIRER ID 805) and was written without patient involvement. Patients' associations will be involved in the dissemination of study design and results. The results of the study will be presented during scientific symposia or published in scientific journals.
NCT04611295.
新冠疫情迫使医疗系统通过尽量减少转运来保护医院内转运过程中的患者和医护人员，从而促使远程医疗系统的使用。在神经病学领域，远程医疗已用于急诊环境中，在基层医院和中心医院网络之间进行急性卒中管理，并取得了良好效果。然而，目前尚缺乏关于远程医疗在非卒中急性神经系统疾病患者就诊急诊科时应用的数据。
这是一项关于在急诊科使用远程会诊诊治非卒中神经系统疾病的干预性、开放标签试验。本研究旨在为转诊至没有24小时神经科会诊医生的医院（基层医院）、有急性神经系统症状的患者开发一个远程会诊系统（远程神经评估与支持系统，TeleNS）。研究对象将包括6个月内转诊至两家基层医院的100例急诊科患者，他们将被要求进行远程会诊而非亲自就诊。作为对照组，将评估过去2年同一时期基层医院急诊科收治患者的回顾性可用数据。主要目的是评估与亲自检查相比，急诊科的TeleNS是否能保证更快但质量上不逊色的诊断/治疗流程，确保所有必要检查和治疗的可及性并实现一致的时间节省。
该试验依据意大利卫生部提供的远程医疗临床研究国家指南以及随机试验标准方案项目声明指南进行设计。本研究方案于2020年9月获得艾米利亚-罗马涅大区伦理委员会批准（编号/识别号：942/2020/DISP/AOUMO SIRER ID 805），且在撰写过程中未让患者参与。患者协会将参与研究设计和结果的传播。研究结果将在科学研讨会上展示或发表在科学期刊上。
NCT04611295
