TELENeurological Support for Emergency Department (TELENS-ED)

August 10, 2022 updated by: Stefano Meletti, Azienda Ospedaliero-Universitaria di Modena

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy
        • Azienda Ospedaliero Universitaria di Modena
      • Modena, Italy, 41123
        • Azienda USL di Modena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Teleneurological evaluation and support
teleneurological evaluation using a medical device certified as telemedicine system
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Teleconsultation clinical application
Time Frame: 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.
6 months
Teleconsultation diagnostic efficacy
Time Frame: 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.
6 months
Teleconsultation efficacy - hospitalization
Time Frame: 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.
6 months
Time 'door to end of diagnostic process'
Time Frame: 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.
6 months
Time 'door to end of neurological evaluation'
Time Frame: 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 6 months
Evaluation of costs, or cost-effectiveness. For the evaluation of costs, it will be developed a model that considers the cost of the system on the one hand, and the savings in terms of personnel (medical personnel, paramedics and ambulances costs). Outcome indicator.
6 months
Evaluation of the level of satisfaction of the users
Time Frame: 6 months
For this purpose an evaluation form will be provided to patients / family members. Users satisfaction will be measured by visual analogue scale (VAS) where 100 is the highest satisfaction and 0 is the lowest. Outcome indicator.
6 months
Evaluation of the level of satisfaction of the health personnel.
Time Frame: 6 months
For this purpose an evaluation form will be provided to medical personnel involved. Personnel satisfaction will be measured by visual analogue scale (VAS) where 100 is the highest satisfaction and 0 is the lowest. Outcome indicator.
6 months
Teleconsultation failure
Time Frame: 6 months
Percentage of cases assessed by teleconsultation for which the neurologist was unable to make remote decisions and requested for sending the patient to Hub Hospital for a "first-person" evaluation. Process indicator.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Collaborators

Azienda USL Modena

Investigators

  • Principal Investigator: Antonio Luciani, MD, Azienda Ospedaliero Universitaria Policlinico Modena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2020

Primary Completion (ANTICIPATED)

October 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (ACTUAL)

November 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 942/2020/DISP/AOUMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Data will be available at study end

IPD Sharing Access Criteria

Upon request to principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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