Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT01625104
Status:
COMPLETED
Last Update Posted:
2017-12-15
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'evakline@med.umich.edu', 'phone': '734 9985909', 'title': 'Eva Kline-Rogers MS, RN', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Agressive Intervention', 'description': 'Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:\n\n1. Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.\n2. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers\n3. Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing\n4. Written plan from sites detailing plans to change processes of care.', 'otherNumAtRisk': 448, 'otherNumAffected': 0, 'seriousNumAtRisk': 448, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Control Strategy', 'description': 'Hospitals randomized to the control group were instructed to conduct "business as usual".\n\nBusiness as usual was defined as normal protocol for treatment of STEMI patients at each individual site +/- quality improvement efforts. No contact or advice was given to the sites from the coordinating center.', 'otherNumAtRisk': 434, 'otherNumAffected': 0, 'seriousNumAtRisk': 434, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Sites With Reduction in Door to Balloon Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Aggressive Stategy'}, {'id': 'OG001', 'title': 'Group 2: Control Strategy', 'description': 'Hospitals randomized to the control group were instructed to conduct "business as usual".'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Arrival to balloon inflation, measured in minutes (generally less than 120 mins)', 'description': 'Arrival time in Emergency Department to first balloon inflation in the coronary artery.\n\nAny reduction in median Door to Balloon Time from baseline to follow-up was counted as reduction in time', 'unitOfMeasure': 'percentage of sites with improved D2B', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Agressive Strategy', 'description': 'Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:\n\n1. Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.\n2. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers\n3. Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing\n4. Written plan from sites detailing plans to change processes of care.'}, {'id': 'FG001', 'title': 'Group 2: Control', 'description': 'Hospitals randomized to the control group were instructed to conduct "business as usual".'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '434'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '434'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '6 sites were randomized to the aggressive strategy and 6 sites were randomized to control.', 'preAssignmentDetails': 'Site were randomized according to baseline Door to Balloon times.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '434', 'groupId': 'BG001'}, {'value': '882', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Agressive Intervention', 'description': 'Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:\n\n1. Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.\n2. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers\n3. Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing\n4. Written plan from sites detailing plans to change processes of care.'}, {'id': 'BG001', 'title': 'Group 2: Control Strategy', 'description': 'Hospitals randomized to the control group were instructed to conduct "business as usual".\n\nBusiness as usual was described as site specific protocol for treatment of STEMI patient +/- any ongoing quality improvement efforts. No specific recommendations were given to sites from the coordinating center.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '312', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 882}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2012-06-19', 'resultsFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-15', 'studyFirstPostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Sites With Reduction in Door to Balloon Time', 'timeFrame': 'Arrival to balloon inflation, measured in minutes (generally less than 120 mins)', 'description': 'Arrival time in Emergency Department to first balloon inflation in the coronary artery.\n\nAny reduction in median Door to Balloon Time from baseline to follow-up was counted as reduction in time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myocardial Infarction', 'Time to Treatment', 'Door to Balloon Time'], 'conditions': ['STEMI']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess whether an aggressive quality improvement intervention strategy will decrease time from hospital presentation to first balloon inflation in non-transfer patients with acute ST segment elevation MI (STEMI) treated with primary percutaneous coronary intervention (PCI). Twelve hospitals in Michigan were randomized to either aggressive intervention or control. The intervention consisted of Grand Rounds at each hospital, sharing of best practices, and coordinating center staff working closely with staff at each intervention hospital to discuss solutions to barriers to rapid treatment for STEMI patients.', 'detailedDescription': 'The participating hospitals randomized to the aggressive intervention strategy actively worked to create teams to analyze processes of care for STEMI patients, identify areas needing improvement, and implemented strategies to streamline treatment.\n\nHospitals randomized to control were instructed to conduct "business as usual".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ST segment myocardial infarction, non transfer patients, with symptom onset to balloon time less than or equal to 24 hours.\n\nExclusion Criteria:\n\n* Patients transferred from one facility to another,\n* non ST segment myocardial infarction patients.'}, 'identificationModule': {'nctId': 'NCT01625104', 'acronym': 'RAPID-PCI', 'briefTitle': 'Randomized Trial of a Quality Improvement Intervention to Decrease D2B Time in Primary PCI for AMI', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Randomized Trial of Aggressive Process of Care Quality Improvement Intervention to Decrease Door to Balloon Time in Primary PCI for Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '1998-0080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Aggressive Intervention Strategy', 'description': 'Hospitals were randomized to an aggressive intervention strategy or to "business as usual". The hospitals randomized to the aggressive intervention strategy underwent the following:\n\n1. Grand Rounds conducted by physician and nurse from the Coordinating Center. This included a formal presentation on the evidence supporting rapid time to treatment in STEMI patients and evidence based strategies for reducing treatment delays.\n2. Discussion with staff regarding perceived barriers to treatment and suggestions/ideas for strategies to overcome these barriers\n3. Follow-up monthly phone conferences to continue to discuss strategies and ideas sharing\n4. Written plan from sites detailing plans to change processes of care.', 'interventionNames': ['Other: Agressive Intervention Process Improvement Strategies']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2: Control Strategy', 'description': 'Hospitals randomized to the control group were instructed to conduct "business as usual".', 'interventionNames': ['Other: Non Intervention']}], 'interventions': [{'name': 'Non Intervention', 'type': 'OTHER', 'description': 'Business as usual', 'armGroupLabels': ['Group 2: Control Strategy']}, {'name': 'Agressive Intervention Process Improvement Strategies', 'type': 'OTHER', 'armGroupLabels': ['Group 1: Aggressive Intervention Strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Mauro Moscucci, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Eva M Kline-Rogers, MS, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Blue Cross Blue Shield of Michigan Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Coordinator', 'investigatorFullName': 'Eva Kline-Rogers', 'investigatorAffiliation': 'University of Michigan'}}}}