Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-03 @ 4:48 PM
Study NCT ID:
NCT02170818
Status:
COMPLETED
Last Update Posted:
2014-06-23
First Post:
2014-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Faculty's Ability to Speak Up to Others in the Operating Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016887', 'term': 'Cardiopulmonary Resuscitation'}], 'ancestors': [{'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-20', 'studyFirstSubmitDate': '2014-06-17', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speaking-Up Behavior', 'timeFrame': 'Immediate', 'description': 'Subjects were assessed by trained raters as to whether they spoke-up when safety related errors were made during a realistic simulation case.'}], 'secondaryOutcomes': [{'measure': 'Speaking-up Behaviors', 'timeFrame': 'Immediate', 'description': "Anesthesiologist subject's behavior in speaking-up to a surgeon, nurse, and colleague during a realistic simulation case were assessed descriptively."}, {'measure': 'Self-reported hurdles and enablers of speaking-up', 'timeFrame': '1 hour', 'description': 'A qualitative analysis of stated hurdles or enablers for speaking-up or not was conducted from video recordings of a post-case structured debriefing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Education', 'Curriculum', 'Anesthesiology', 'Operating Rooms'], 'conditions': ['Faculty, Medical']}, 'descriptionModule': {'briefSummary': 'Importance Team members speaking-up by raising concerns about inappropriate or unsafe actions of others within the team can have direct, immediate, and preventive effect on adverse outcomes. However, little is known about the hurdles and enablers of this behavior in healthcare, especially within the operating room setting.\n\nObjective\n\n1\\. Determine if an educational workshop would improve speaking-up behaviors of practicing anesthesiologists when presented with realistically-simulated clinical situations. 2.Describe speaking-up behaviors addressed to a surgeon, a nurse, and a colleague. 3. Identify the self-reported hurdles and enablers for speaking-up in those situations encountered.\n\nDesign Randomized controlled experiment of an educational workshop intervention on communication behaviors in a simulated case. Qualitative analysis of debriefing conversations following the simulated case.\n\nSetting Established academic simulation center\n\nParticipants Seventy-one practicing anesthesiologists from four academic medical centers and one community hospital\n\nIntervention Fifty minute educational workshop on speaking-up that included rationale, conversational techniques, a rubric for speaking-up, and role-play.', 'detailedDescription': 'Main Outcomes and Measures\n\n1\\. Observed communication in a simulated case that included a surgeon falling asleep during surgery, inappropriate activation of a speakerphone by a nurse, and an incorrect treatment order by a colleague in response to a venous air embolism. 2. Transcribed conversation during a structured debriefing, analyzed for hurdles and enablers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attending Anesthesiologist\n\nExclusion Criteria:\n\n* Prior exposure to test case'}, 'identificationModule': {'nctId': 'NCT02170818', 'briefTitle': "Improving Faculty's Ability to Speak Up to Others in the Operating Room", 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': "Improving Faculty's Ability to Speak Up to Others in the Operating Room: A Simulation Based Randomized Controlled Trial of an Educational Intervention", 'orgStudyIdInfo': {'id': '2008P001015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Workshop on Speaking-Up', 'description': 'Educational Workshop on Speaking-Up Before Simulated Case', 'interventionNames': ['Other: Educational Workshop on Speaking-Up']}, {'type': 'SHAM_COMPARATOR', 'label': 'Unrelated Education', 'description': 'Unrelated Education (CPR) before simulated case (Educational Workshop on Speaking-up after case and debriefing)', 'interventionNames': ['Other: Unrelated Education (CPR)']}], 'interventions': [{'name': 'Educational Workshop on Speaking-Up', 'type': 'OTHER', 'description': 'Educational workshop including lecture, discussion, role-play Concepts include: 2-challenge rule, pairing advocacy and inquiry', 'armGroupLabels': ['Educational Workshop on Speaking-Up']}, {'name': 'Unrelated Education (CPR)', 'type': 'OTHER', 'description': 'Unrelated Education (CPR workshop) including: lecture, discussion Topics covered: Cardiac Life Support algorithms, CPR, Medications', 'armGroupLabels': ['Unrelated Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02139', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Daniel B Raemer, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anesthesia Patient Safety Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anaesthesia', 'investigatorFullName': 'Daniel Raemer, Ph.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}