Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT00708760
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2008-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moderate Sedation Educational Software
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Vastly under enrolled due to delays in software development', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2008-06-30', 'studyFirstSubmitQcDate': '2008-06-30', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine which group - web based or paper based is more effective', 'timeFrame': 'at the end of simulation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['web based learning', 'moderate sedation'], 'conditions': ['Moderate Sedation Training']}, 'descriptionModule': {'briefSummary': 'We propose to develop and evaluate an interactive education software for administering moderate sedation by non-anesthesiologists.', 'detailedDescription': "The course will be founded upon JCAHO's and ASA's guidelines for sedation, emphasizing the concepts with animations, audio, scenarios, and quizzes. Interactive feedback will be incorporated to guide the clinician during the course. The course will be offered commercially over the World Wide Web, with successful completion providing continuing medical education (CME) credit. It will fulfill JCAHO recommended guidelines. In a controlled simulated environment, the hypothesis that the web based training protocol will provide the practitioner the knowledge base necessary to manage the four scenarios as well or better than practitioners completing the standard moderate sedation certification course will be tested.\n\n1\\) Evaluate the effectiveness of the course. The University of Utah Center for Patient Simulation is an ideal environment to evaluate the efficacy of a web-based training course. The new web-based course will be compared to standard course material and lessons. We will recruit 40 nurses who administer moderate sedation at the University of Utah Health Sciences Center. Half of the nurses will receive traditional training (typical course and guidelines published from the literature), and half will receive the web-based course. Users will be tested on their knowledge of moderate sedation with four moderate sedation scenarios, in which the simulated patient experiences over-sedation, apnea, and excessive pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'nurses providing moderate sedation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* general nursing staff at the University of Utah\n* currently required to obtain moderate sedation training\n* an equal basis all clinicians in the respective departments\n\nExclusion Criteria:\n\n* nurses and other personnel who do not administer moderate sedation'}, 'identificationModule': {'nctId': 'NCT00708760', 'briefTitle': 'Moderate Sedation Educational Software', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Moderate Sedation Education Software', 'orgStudyIdInfo': {'id': '23011'}, 'secondaryIdInfos': [{'id': 'University of Utah VIP grant'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '2', 'description': 'web based learning group', 'interventionNames': ['Behavioral: web based training']}, {'label': '1', 'description': 'paper based learning group', 'interventionNames': ['Behavioral: paper based training']}], 'interventions': [{'name': 'paper based training', 'type': 'BEHAVIORAL', 'description': 'read selected material, test skills learned in simulator lab', 'armGroupLabels': ['1']}, {'name': 'web based training', 'type': 'BEHAVIORAL', 'description': 'read and view selected web based material, test skills learned in simulator lab', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'James Agutter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}