Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT05648760
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation-based Training Improves Competency in Communicating Bad News
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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2022-12-05', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with competency in communicating bad news behavioral measure', 'timeFrame': 'One month after training', 'description': 'Number of Participants with competency in communicating bad news behavioral measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['simulation', 'competency'], 'conditions': ['Simulation of Physical Illness']}, 'descriptionModule': {'briefSummary': 'Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families.', 'detailedDescription': 'Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The term "bad news" refers to any information transmitted to patients or their families that directly or indirectly involves a negative change in their lives or view of their future. Existing reports show that practicing doctors and residents lack confidence and skill in performing this task, and most have never received any formal training. Breaking bad news is a complex task requiring many skills including communication, responding to emotional reactions, and involving the family members.\n\nThe objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families. We hypothesize that simulation-based training intervention will improve medical student competency in communicating bad news to patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Residents working at the Intensive Care Unit.\n\nExclusion Criteria:\n\n* Residents who are are available for the intervention or who don't have the appropriate number of meetings captured for data analysis"}, 'identificationModule': {'nctId': 'NCT05648760', 'briefTitle': 'Simulation-based Training Improves Competency in Communicating Bad News', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Simulation-based Training Improves Medical Student Competency in Communicating Bad News to Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022ZDYYLL01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Usual training', 'description': 'Participants randomized to the control condition received a standard training of how to communicate bad news to patients', 'interventionNames': ['Behavioral: Simulation training']}, {'type': 'EXPERIMENTAL', 'label': 'Simulation training', 'description': 'Participants randomized to the simulation training group received simulation training based on a standard training of how to communicate bad news to patients', 'interventionNames': ['Behavioral: Simulation training']}], 'interventions': [{'name': 'Simulation training', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to the simulation condition received simulation training based on a standard training of how to communicate bad news to patients', 'armGroupLabels': ['Simulation training', 'Usual training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingyyuan Xu, MD', 'role': 'CONTACT', 'email': '13851417209@163.com', 'phone': '86-025-83262550'}], 'facility': 'Zhongda hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jingyuan Xu, M.D.', 'role': 'CONTACT', 'email': '13851417209@163.com', 'phone': '86-025-83262550'}], 'overallOfficials': [{'name': 'Jingyuan Xu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southeast University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jingyuan,Xu', 'investigatorAffiliation': 'Southeast University, China'}}}}