NCT04611295

TELENeurological Support for Emergency Department

TELENeurological Evaluation and Support for the Emergency Department (TELENS-ED): an Open-label Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria di Modena · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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. Secondary objectives: to determine if the usage of a teleconsultation physician for neurological evaluation compared to a conventional physician "de visu" in urgent but non-life-threatening neurological cases, is superior regarding 1) effect evaluation, 2) process evaluation, and 3) cost-benefit analysis. Outcome and process indicators will be assessed and compared in the following groups: * Experimental group (cases): a) patients who access the Policlinico Hospital ED in the afternoon and night-time and on holidays; b) patients who access the Mirandola Hospital ED during the period of the study. * Control Groups: a) retrospectively collected data on neurological consultation performed by OCB Neurology for Policlinico Hospital patients in the same time slots in the same months of the last two years.; b) retrospectively collected data on neurological consultation performed by Carpi Neurology for Mirandola Hospital patients in the same time slots in the same months of the last two years.

Conditions

• Emergencies
• Neurologic Disorder

Interventions

Type	Name	Description
PROCEDURE	Teleneurological evaluation and support	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-10-30
• Completion: 2022-12-30
• First posted: 2020-11-02
• Last updated: 2022-08-11

Locations

2 sites across 1 country: Italy