Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT02365792
Status:
WITHDRAWN
Last Update Posted:
2023-08-31
First Post:
2014-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Professional Development in Emergency Medical Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2014-06-21', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment protocol adherence', 'timeFrame': 'Up to 12 months', 'description': 'Measured by comparing the prescribed actions to be taken following the selected standing order (-s) or procedures, with the actual action (-s) taken.'}], 'secondaryOutcomes': [{'measure': 'Length of Stay in the ED', 'timeFrame': 'Up to 12 months', 'description': 'Measured as the duration between the times the patient is assigned with a unique EAD number in the emergency department and the disposition decision is marked in the Electronic Patient Record (EPR), indicating that the patient is ready to be discharged from the ED.'}, {'measure': 'Prehospital Patient Time Interval', 'timeFrame': 'Up to 12 months', 'description': 'Measured as the duration between the arrival time at the scene and and arrival time at the ED.'}, {'measure': 'Consistency in reported diagnose and the choice of PIT standing order (-s) or procedure (-s)', 'timeFrame': 'Up to 12 months', 'description': 'Measured by comparing the selected standing order (-s) or protocol (-s) and the reported diagnose (-s).'}, {'measure': 'Alignment between diagnostic accuracy and interventions taken.', 'timeFrame': 'Up to 12 months', 'description': 'Measures by comparing the use of available scales and the corresponding prescribed action (-s) to be taken following the standing orders.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinical Decision Support', 'Clinical Practice Guidelines', 'Emergency Medical Services'], 'conditions': ['Clinical Decision Support', 'Clinical Practice Guidelines', 'Emergency Medical Services']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.kuleuven.be/wieiswie/nl/person/00096106', 'label': 'PhD Project'}, {'url': 'http://goo.gl/i5mv0R', 'label': 'Principal Investigator'}, {'url': 'http://goo.gl/sz9yDC', 'label': 'Participating Facility'}, {'url': 'http://goo.gl/UokRfN', 'label': 'Affiliated study Department'}]}, 'descriptionModule': {'briefSummary': 'The ProDEms-trial focuses on nurses and ambulance drivers working in prehospital care, taking care on the one hand of patients suffering from time-sensitive critical conditions like STEMI, acute stroke or severe traumatic brain injury, and on the other hand of patients whose lives are not in immediate danger but suffer from acute exacerbation of chronic conditions or suffer from acute pain.\n\nIn the current study the investigators will use a multistage approach to test the hypothesis whether the use of a CDSS in prehospital emergency care will: 1. Improve protocol adherence, 2. Reduce emergency department length of stay, 3. Improves diagnostic accuracy; without impeding the workflow of the prehospital team or impairing patient safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '112 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who receive treatment from the Paramedic Intervention Team (PIT) in the prehospital Emergency Medical Services (EMS) area of the University Hospitals, Leuven.\n\nExclusion Criteria:\n\n* Patient-related interventions not dispatched by the Emergency Medical Dispatch center (EMD)\n* Patient related interventions during transport between two healthcare facilities or in mass casualty situations.'}, 'identificationModule': {'nctId': 'NCT02365792', 'acronym': 'ProDEms', 'briefTitle': 'Professional Development in Emergency Medical Services', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Efficacy of a Clinical Decision Support System in Prehospital Care: Single Blind, Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'ProDEmsTrial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CDSS1', 'description': 'The CDSS1 will provide decision support according to existing protocols for clinical procedures and medical treatment, mainly starting from specific symptoms or diagnostic related patients groups. The symptom oriented approach is categorised in a specific list of predetermined conditions.', 'interventionNames': ['Procedure: Clinical Decision Support Tool for Prehospital Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CDSS2', 'description': 'The CDSS2 will provide decision support according to existing protocols for clinical procedures and medical treatment, mainly starting from specific symptoms or diagnostic related patients groups. The symptom oriented approach is categorised in a specific list of predetermined conditions.', 'interventionNames': ['Procedure: Clinical Decision Support Tool for Prehospital Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Booklet', 'description': 'The control group will provide prehospital patient care with usual decision support: a pocket-size booklet, backed by a mobile phone through which the PIT can get in contact with an Emergency Physician.', 'interventionNames': ['Procedure: Clinical Decision Support Tool for Prehospital Care']}], 'interventions': [{'name': 'Clinical Decision Support Tool for Prehospital Care', 'type': 'PROCEDURE', 'otherNames': ['CDSS'], 'description': 'A clinical decision support system (CDSS) is a health information technology system that is designed to assist physicians and other health professionals with clinical decision-making tasks. A working definition of the Centre for Health Evidence: "Clinical Decision Support systems link health observations with health knowledge to influence health choices by clinicians for improved health care".', 'armGroupLabels': ['Booklet', 'CDSS1', 'CDSS2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'Academic Center for General Practice', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Bert mr Aertgeerts, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Academic Center for General Practice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Academic Center for General Practice', 'investigatorFullName': 'Olivier Hoogmartens', 'investigatorAffiliation': 'KU Leuven'}}}}