TELENeurological Evaluation and Support for the Emergency Department (TELENS-ED): an Open-label Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Teleconsultation diagnostic efficacy
研究概览
简要总结
Open-label, non-inferiority, teleconsultation with televisit study to compare efficacy, safety and users satisfaction of a TeleNeurological Support versus "in person" neurological examination in the emergency department
详细描述
The investigtors are going to perform an interventional, open-label study on the use of teleconsultation in the emergency department focused on neurological diseases other than stroke (for which a specific protocol already exists) in two Hospitals of Modena province, Italy.
The study is aimed at developing a remote neurological consultancy system (teleconsultation) for patients with acute neurological symptoms in charge of hospital facilities without 24-hour availability of neurologist consultant.
Pilot project setting: a) ED of Modena Policlinico Hospital in the afternoon, night, and public holidays, time windows in which the Neurologist consultant is not present at Policlinico Hospital; b) ED of Mirandola Hospital.
The project (enrolment) is expected to be developed over a period of 6 months in which 100 patients will be enrolled.
The primary objective is to assess whether a TeleNeurological Evaluation and Support for the Emergency Department can guarantee a faster but qualitatively not inferior diagnostic/therapeutic work-up if compared with in person examination, assuring the availability of all the necessary examinations and treatments with a consistent time reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged > 18 years
- •Symptoms related to possible acute / subacute neurological pathology, or worsening of known neurological pathology, for which the ED physician considers neurological consultation indicated / necessary.
- •Signing of informed consent to remote neurological evaluation.
排除标准
- •All life-threatening emergency cases, where the study procedure would interfere with clinical practice
- •Patients with known neurological pathology or with clinical severity to such an extent that the need for admission to OCB/Carpi Neurology unit or to the internal wards of the Policlinico is immediately evident.
- •Refusal of the patient/caregiver to perform remote neurological evaluation.
结局指标
主要结局
Teleconsultation diagnostic efficacy
时间窗: 6 months
Percentage of patients re-admitted to the ED in the 7 days following the date of neurological consultation. It is expected that for the patients of the neurological teleconsultation the % of re-admission to ED will not exceed that of the patients undergone standard neurological advice.
Time 'door to end of diagnostic process'
时间窗: 6 months
The total time from ED admission to the end of the diagnostic and therapeutic process (time spent in the ED): this time is expected to be significantly shorter for patients in the teleneurology group than for patients having a standard neurological advice.
Teleconsultation clinical application
时间窗: 6 months
Percentage of patients who undergo neurological teleconsultation over the number of patients who access on the days and in the time slots in which the service is active and needing a neurological evaluation.
Time 'door to end of neurological evaluation'
时间窗: 6 months
The time from the ED admission to the end of the remote neurological consultation: this time is expected to be significantly shorter for patients in the teleneurology group than for patients having a standard neurological advice
Teleconsultation efficacy - hospitalization
时间窗: 6 months
Percentage of hospitalized patients among those undergone TeleNeurology compared to percentage of hospitalization for patients with in person neurological evaluation. It is expected that for patients of the teleneurology group the % of hospitalization will not exceed that of patients undergone standard neurological advice.
次要结局
- Evaluation of the level of satisfaction of the health personnel.(6 months)
- Teleconsultation failure(6 months)
- Cost-effectiveness(6 months)
- Evaluation of the level of satisfaction of the users(6 months)
研究者
Stefano Meletti
Study coordinator and Clinical Investigator
Azienda Ospedaliero-Universitaria di Modena