TELENeurological Support for Emergency Department

NCT04611295 | Unknown DMC

• 1 other identifier: 942/2020/DISP/AOUMO
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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

Conditions

Emergencies; Neurologic Disorder

Outcome Measures

Primary Outcomes (5)

• Teleconsultation clinical application

  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

  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

  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'

  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'

  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 Outcomes (4)

• Cost-effectiveness

  6 months

• Evaluation of the level of satisfaction of the users

  6 months

• Evaluation of the level of satisfaction of the health personnel.

  6 months

• Teleconsultation failure

  6 months

Study Arms (1)

Teleneurological evaluation and support

EXPERIMENTAL

teleneurological evaluation using a medical device certified as telemedicine system

Procedure: Teleneurological evaluation and support

Interventions

Teleneurological evaluation and support PROCEDURE

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.

Teleneurological evaluation and support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead
• Azienda USL Modena: collaborator

Study Sites (2)

Azienda USL di Modena

Modena, 41123, Italy

Location

Azienda Ospedaliero Universitaria di Modena

Modena, Italy

Location

Related Publications (35)

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MeSH Terms

Conditions

Emergencies; Nervous System Diseases

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Antonio Luciani, MD

  Azienda Ospedaliero Universitaria Policlinico Modena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator and Clinical Investigator

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: December 1, 2020
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available at study end
• Access Criteria: Upon request to principal investigator

Locations

IT (2)