Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-26 @ 8:18 PM
Study NCT ID:
NCT04611295
Status:
UNKNOWN
Last Update Posted:
2022-08-11
First Post:
2020-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TELENeurological Support for Emergency Department
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Study Overview
Official Title:
TELENeurological Evaluation and Support for the Emergency Department (TELENS-ED): an Open-label Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELENS-ED
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: