Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT00958958
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2009-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-25', 'studyFirstSubmitDate': '2009-08-13', 'studyFirstSubmitQcDate': '2009-08-13', 'lastUpdatePostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Phase 1: patient who've received interventions based on evidence proportion informed by the indicators", 'timeFrame': '9 months'}, {'measure': 'Phase 2: increase of prescription of evidence based treatment in clinical practice', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Total mortality and major cardiovascular events', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Coronary Syndrome', 'randomized cluster trial', 'quality improvement'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '22665103', 'type': 'DERIVED', 'citation': 'Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama AA, Zazula AD, Santucci EV, Victor E, Tenuta M, Carvalho V, Mira VL, Pieper KS, Weber B, Mota LH, Peterson ED, Lopes RD; Bridge-Acs Investigators. Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial. JAMA. 2012 May 16;307(19):2041-9. doi: 10.1001/jama.2012.413.'}, {'pmid': '22424001', 'type': 'DERIVED', 'citation': 'Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama A, Zazula AD, Santucci E, Victor E, Flato UA, Tenuta M, Carvalho V, Mira VL, Pieper KS, Mota LH, Peterson ED, Lopes RD; BRIDGE-ACS. A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial. Am Heart J. 2012 Mar;163(3):323-29, 329.e1. doi: 10.1016/j.ahj.2012.02.004.'}]}, 'descriptionModule': {'briefSummary': 'Phase 1: An observational study (registry) will be conducted which will objectively document the ACS clinical practice in Brazilian public hospitals, and identify the important barriers for the evidence usage incorporation in the clinical practice.\n\nPhase 2: A Cluster randomized clinical trial in which public hospital will be randomized to receive or not a multifaceted strategy in order to increase evidence based therapy in clinical practice.', 'detailedDescription': "STUDY POPULATION:\n\nPatients with thoracic pain who the emergency department physician suspects of ACS and plans start a treatment for this issue; It will be excluded patients transferred of others institutions with 12 hours of symptoms.\n\nPROGRAM:\n\nThere are multifaceted Interventions Including\n\n1. Distribution of educational materials\n2. Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used\n3. Reminders: specific information that is designed or intended to prompt a health professional to recall information (patient bracelets, labels, posters, pocket cards, checklists).\n4. Practical training\n\nENDPOINTS:\n\nPhase 1 Primary outcome; patient who've received interventions based on evidence proportion informed by the indicators; Phase 2\n\nPrimary outcome:\n\nIncrease of prescription of evidence based treatment in clinical practice Secondary outcome Total mortality and major cardiovascular events"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Eligibility criteria\n\nInclusion Criteria:\n\n* Patients with thoracic pain who the emergency department physician suspects of ACS and plans start a treatment for this issue\n\nExclusion Criteria:\n\n* Patients transferred from others institutions within 12 hours of the symptoms\n\nCluster Eligibility Criteria\n\n* National Public Hospitals with emergency department. A cluster can be one hospital with emergency department, or 2 or more hospitals (for example: 1 emergency hospital and 1 general hospital which receive the patients to perform PCI).'}, 'identificationModule': {'nctId': 'NCT00958958', 'acronym': 'BRIDGE', 'briefTitle': 'Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes', 'orgStudyIdInfo': {'id': 'IEP012009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Quality improvement program', 'description': 'There are multifaceted Interventions for the clinic hospital team Including\n\n1. Distribution of educational materials\n2. Case manager\n3. Reminders\n4. Practical training', 'interventionNames': ['Other: multifaceted strategy']}, {'type': 'NO_INTERVENTION', 'label': 'Hospital standard treatment', 'description': 'Hospital standard treatment'}], 'interventions': [{'name': 'multifaceted strategy', 'type': 'OTHER', 'description': 'There are multifaceted Interventions Including\n\n1. Distribution of educational materials: distribution of published or printed recommendations for clinical care.\n2. Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used\n3. Reminders\n4. Practical training', 'armGroupLabels': ['Quality improvement program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04005-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Coração', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Otávio Berwanger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital do Coracao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}