Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT00715767
Status:
COMPLETED
Last Update Posted:
2010-10-14
First Post:
2008-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Basic Life Support (BLS) and Barriers to Cross-Cultural Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}, {'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-13', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-14', 'lastUpdatePostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine selected cognitive knowledge and critical thinking skills.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BLS training', 'CPR', 'post graduate education', 'resource-limited settings', 'medical education', 'CPR retention', 'cultural barriers'], 'conditions': ['Medical Education']}, 'descriptionModule': {'briefSummary': "This is a randomized, multi-center intervention trial comparing two educational programs on healthcare provider performance in the Botswana national hospital system. This study addresses the critical question of how to effectively and consistently measure and associate CPR knowledge and psychomotor skills, enabling the optimization of the learners' environment.", 'detailedDescription': 'Context: The World Health Organization (WHO) estimates that more than 16 million people die from cardiovascular diseases each year, accounting for more than one-third of global deaths. Almost half of these deaths take place in hospitalized settings. Standard acute medicine education programs have had limited success in training hospital based healthcare providers to acquire, retain, and transfer knowledge and skills to impact patient outcomes in both developed and developing countries. There is a gap between the cognitive knowledge and critical thinking skills attained during courses and the technical and team skills actually performed by hospital-based healthcare providers. This gap between existing knowledge and performed skills restricts care delivery, underutilizes available resources, and contributes to the number of preventable deaths. This gap is further accentuated in resource limited settings, where barriers to implementation of successful acute medicine training programs are often accentuated.\n\nPrimary Objective:\n\n1\\. To determine selected cognitive knowledge and critical thinking skills which are associated with technical and team skills performance assessed immediately following Basic Life Support (BLS) for Health Care Providers course training.\n\nSecondary Objectives:\n\n1\\. To identify cultural, healthcare environment and educational barriers that currently impede acquisition, retention, and transfer of knowledge and skills in acute medicine educational programs in resource limited settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthcare providers involved in patient contact.\n2. Participation in BLS for Healthcare Provider Course\n\nExclusion Criteria:\n\n1. Have received formal Basic Life Support training in previous 12 months.\n2. Inability to perform or complete cognitive and skills assessment testing (pre, immediate post, 3 or six month post).\n3. Healthcare personnel performing an educational rotation at the district or referral hospital will not be eligible due to loss of follow-up.'}, 'identificationModule': {'nctId': 'NCT00715767', 'acronym': 'BLSinBotswana', 'briefTitle': 'Basic Life Support (BLS) and Barriers to Cross-Cultural Education', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Correlation of Cognitive and Technical Skills Assessment for Basic Life Support and Identification of Barriers to Cross-Cultural Education', 'orgStudyIdInfo': {'id': '2008-1-5700'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Assessment', 'type': 'BEHAVIORAL', 'otherNames': ['cognitive assessment', 'critical thinking', 'outcome measures of adequacy of chest compressions', 'outcome measures of adequacy of ventilations'], 'description': 'Cognitive Assessment:\n\nKnowledge base and critical thinking will be evaluated by a 50-question BLS multiple-choice examination. At the designated 4 cognitive assessments in the study (pre-course, immediately post course, 3 months and 6 months) 50 equivalent questions will be used to cover all core BLS objectives. Technical Skills Assessment:\n\nPrimary outcome measures of adequacy of chest compressions and ventilations as well as key actions for each of the 3standardized basic life support skill tests during 3-minute testing scenarios. Video review by 2independent experts will be utilized for objective assessment of time and order dependent skills, and manikin output will be utilized to assess qualitative effectiveness of skills (adequate ventilation, compression, and defibrillation).\n\nSurvey Instrument for Barriers to Acute Medicine Education:\n\nA survey tool will be used to identify barriers to acute medicine education implementation and efficacy.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pete Meaney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Laerdal Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Pete Meaney, MD', 'oldOrganization': "Children's Hospital of Philadelphia"}}}}