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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Teleconsultation clinical application', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Teleconsultation diagnostic efficacy', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Teleconsultation efficacy - hospitalization', 'timeFrame': '6 months', 'description': '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.'}, {'measure': "Time 'door to end of diagnostic process'", 'timeFrame': '6 months', 'description': '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.'}, {'measure': "Time 'door to end of neurological evaluation'", 'timeFrame': '6 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Evaluation of the level of satisfaction of the users', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Evaluation of the level of satisfaction of the health personnel.', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Teleconsultation failure', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergencies', 'Neurologic Disorder']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Piano per il miglioramento dell'accesso in Emergenza Urgenza nelle strutture sanitarie dell'Emilia-Romagna; https://bur.regione.emilia-romagna.it/dettaglio-inserzione?i=7b644492dfe2471787f041d37a19f2e8; 24.07.2019"}, {'type': 'BACKGROUND', 'citation': "WHO. 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Epub 2020 May 20.'}, {'pmid': '32240581', 'type': 'BACKGROUND', 'citation': "Keesara S, Jonas A, Schulman K. Covid-19 and Health Care's Digital Revolution. N Engl J Med. 2020 Jun 4;382(23):e82. doi: 10.1056/NEJMp2005835. Epub 2020 Apr 2. No abstract available."}, {'pmid': '34011601', 'type': 'DERIVED', 'citation': 'Mandrioli J, Santangelo M, Luciani A, Toscani S, Zucchi E, Giovannini G, Martinelli I, Cecoli S, Bigliardi G, Scanavini S, Meletti S. TeleNeurological evaluation and Support for the Emergency Department (TeleNS-ED): protocol for an open-label clinical trial. BMJ Open. 2021 May 19;11(5):e048293. doi: 10.1136/bmjopen-2020-048293.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nThe 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.\n\nPilot 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.\n\nThe project (enrolment) is expected to be developed over a period of 6 months in which 100 patients will be enrolled.\n\nThe 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.\n\nSecondary 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.\n\nOutcome and process indicators will be assessed and compared in the following groups:\n\n* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 18 years\n* Symptoms related to possible acute / subacute neurological pathology, or worsening of known neurological pathology, for which the ED physician considers neurological consultation indicated / necessary.\n* Signing of informed consent to remote neurological evaluation.\n\nExclusion Criteria:\n\n* All life-threatening emergency cases, where the study procedure would interfere with clinical practice\n* 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.\n* Refusal of the patient/caregiver to perform remote neurological evaluation.'}, 'identificationModule': {'nctId': 'NCT04611295', 'acronym': 'TELENS-ED', 'briefTitle': 'TELENeurological Support for Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Modena'}, 'officialTitle': 'TELENeurological Evaluation and Support for the Emergency Department (TELENS-ED): an Open-label Clinical Trial', 'orgStudyIdInfo': {'id': '942/2020/DISP/AOUMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teleneurological evaluation and support', 'description': 'teleneurological evaluation using a medical device certified as telemedicine system', 'interventionNames': ['Procedure: Teleneurological evaluation and support']}], 'interventions': [{'name': 'Teleneurological evaluation and support', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Teleneurological evaluation and support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41123', 'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda USL di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'Antonio Luciani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero Universitaria Policlinico Modena'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will be available at study end', 'ipdSharing': 'YES', 'accessCriteria': 'Upon request to principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Modena', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda USL Modena', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study coordinator and Clinical Investigator', 'investigatorFullName': 'Stefano Meletti', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Modena'}}}}