Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-31 @ 8:29 AM
Study NCT ID:
NCT04503369
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2020-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of Non-technical Skills in the Pre-hospital Care in the Czech Republic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NTS incidence', 'timeFrame': 'Through study completion, an average of 1 year and until 100 cases from each organization will be collected - 300 observations in total.', 'description': 'The measurement of non-technical skills usage will be evaluated according to the form developed and published by Cooper et al. (2010) as a Team Emergency Assessment Measure (TEAM) tool based on the Likert scale - Never/Hardly ever (0), Seldom (1), About as often as not (2), Often (3), Always/Nearly always (4).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-technical skills', 'pre-hospital care', 'emergency medical services', 'communication', 'situational awareness', 'task management', 'decision making', 'teamwork', 'team leading'], 'conditions': ['Non-technical Skills']}, 'referencesModule': {'references': [{'pmid': '24036193', 'type': 'BACKGROUND', 'citation': 'Cooper SJ, Cant RP. Measuring non-technical skills of medical emergency teams: an update on the validity and reliability of the Team Emergency Assessment Measure (TEAM). Resuscitation. 2014 Jan;85(1):31-3. doi: 10.1016/j.resuscitation.2013.08.276. Epub 2013 Sep 12.'}, {'pmid': '19525052', 'type': 'BACKGROUND', 'citation': 'Napier F, Davies RP, Baldock C, Stevens H, Lockey AS, Bullock I, Perkins GD. Validation for a scoring system of the ALS cardiac arrest simulation test (CASTest). Resuscitation. 2009 Sep;80(9):1034-8. doi: 10.1016/j.resuscitation.2009.04.043. Epub 2009 Jun 13.'}, {'type': 'BACKGROUND', 'citation': 'PERAN, D., KUBALOVÁ, J..: Observation of non-technical skills during resuscitation (Sledování netechnických dovedností při resuscitaci) [article in Czech language]. Urgentní medicína: Časopis pro neodkladnou lékařskou péči. Mediprax CB s.r.o., 2017 (4). ISSN 1212-1924.'}, {'pmid': '35562664', 'type': 'DERIVED', 'citation': 'Peran D, Sykora R, Vidunova J, Krsova I, Pekara J, Renza M, Brizgalova N, Cmorej PC. Non-technical skills in pre-hospital care in the Czech Republic: a prospective multicentric observational study (NTS study). BMC Emerg Med. 2022 May 13;22(1):83. doi: 10.1186/s12873-022-00642-4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (e.g. communication, decision making, situational awareness etc.) in the real practice and how well they use them.', 'detailedDescription': 'The aim of the study is to find out if the Emergency Medical Services (EMS) crews are using the non-technical skills (teamwork and team leading, communication, decision making, situational awareness and task management) in the real practice and how well they use them. According to the observations of individual crews by field supervisors the use of non-technical skills will be compared between different groups (e.g. resuscitation, trauma, medical problems, non-emergency situations etc.). The comparison between the collaborators of the study is not the subject of the study.\n\nMain hypothesis: The EMS crews are using all of the aspects of non-technical skills appropriately.\n\nThe field supervision is also the limitation of the study because it is done by different observers / supervisors, the observation therefore might by affected by subjective feelings. To minimise the subjective view of the situation all of the field supervisors undergo a uniform training of non-technical skills and how to observe and evaluate them.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patient of EMS in participated regions of the Czech Republic where the pre-hospital care is provided by 2 or more crews and the field supervisor is present.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EMS called\n* More than 2 crews on the scene\n* Field supervisor present\n\nExclusion Criteria:\n\n\\- TEAM tool not filled completely'}, 'identificationModule': {'nctId': 'NCT04503369', 'acronym': 'NTS', 'briefTitle': 'Observation of Non-technical Skills in the Pre-hospital Care in the Czech Republic', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Emergency Medical Service, Prague'}, 'officialTitle': 'Observation of Non-technical Skills (e.g. Communication, Team Leader Skills, Teamwork, Situational Awareness Etc.) in the Pre-hospital Care in the Czech Republic', 'orgStudyIdInfo': {'id': 'ZZSMHP_001_2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EMS crews', 'description': 'Crews of Emergency Medical Services', 'interventionNames': ['Behavioral: Non-technical skills']}], 'interventions': [{'name': 'Non-technical skills', 'type': 'BEHAVIORAL', 'description': 'Teamwork The work of the team consists of information exchange and coordination of all activities performed. In-team communication is always calm and assertive, and team members support each other.\n\nTask management With the right planning and preparation of individual activities, the likelihood that all standards of care and best practices will be followed increases.\n\nSituational awareness Situational awareness refers primarily to the collection of information, its understanding and, on that basis, prediction of direction into which the situation will develop. Maintaining situational awareness is crucial in order to move towards the right goal.\n\nDecision-making With good situational awareness, one is able to keep in mind all information needed to make the correct decision at the right time. In some cases, it is advisable to consult with other team members or to verify their consent to the proposed procedure.\n\nCommunication Communication is a vital tool when working in a team.', 'armGroupLabels': ['EMS crews']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36006', 'city': 'Karlovy Vary', 'country': 'Czechia', 'facility': 'Emergency Medical Services of the Karlovy Vary region', 'geoPoint': {'lat': 50.23271, 'lon': 12.87117}}, {'zip': '30100', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Emergency Medical Services of the Pilsner region', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '10100', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Prague Emergency Medical Services', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'David Peran, DrPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Prague Emergency Medical Services'}, {'name': 'Roman Sykora, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emergency Medical Services of the Karlovy Vary Region'}, {'name': 'Jana Vidunová, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emergency Medical Services of the Pilsner Region'}, {'name': 'Ivana Krsova, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emergency Medical Services of the Pilsner Region'}, {'name': 'Jaroslav Pekara, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prague Emergency Medical Services'}, {'name': 'Patrik C Cmorej, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emergency Medical Services of the Usti nad Labem Region'}, {'name': 'Nikola Brizgalová, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emergency Medical Services of the Karlovy Vary Region'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Peran', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Emergency Medical Services of the Karlovy Vary region, Czech Republic', 'class': 'UNKNOWN'}, {'name': 'Emergency Medical Services of the Pilsner region, Czech Republic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of the Education and Training Centre', 'investigatorFullName': 'David Peran', 'investigatorAffiliation': 'Emergency Medical Service, Prague'}}}}