Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-30 @ 4:15 AM
Study NCT ID:
NCT00952250
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2009-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Feedback Reports to Improve Acute Coronary Syndromes (ACS) Care
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': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-01', 'studyFirstSubmitDate': '2009-08-04', 'studyFirstSubmitQcDate': '2009-08-04', 'lastUpdatePostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome is improvement in the composite of targeted metrics.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['quality improvement'], 'conditions': ['Acute Coronary Syndromes']}, 'referencesModule': {'references': [{'pmid': '21245461', 'type': 'DERIVED', 'citation': 'Alexander KP, Wang TY, Li S, Lytle BL, Slattery LE, Calhoun S, Poteat J, Roe MT, Rumsfeld JS, Cannon CP, Peterson ED. Randomized trial of targeted performance feedback to facilitate quality improvement in acute myocardial infarction care. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):129-35. doi: 10.1161/CIRCOUTCOMES.110.958470.'}]}, 'descriptionModule': {'briefSummary': "This project is designed to examine the impact of tailored feedback on site performance.\n\nThe investigators' objective is to evaluate whether a 'personalized and targeted' feedback, education and performance improvement intervention has a greater impact on adherence to recommended guidelines than standard feedback.\n\nThe investigators hypothesize that a site-specific report with centrally identified targets for improvement paired with target specific interventions will enable sites to quickly identify and prioritize salient problem areas, have ready access to an analysis of factors that underlie problems, and formulate an effective action plan. The investigators also hypothesize that those hospitals randomized to receive intervention will be more likely to improve their overall performance, as well as their target specific performance, during the period of observation in direct response to activated QI processes.\n\nOutcomes:\n\nThe primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.\n\nThe secondary outcome is improvement in the composite of targeted metrics.\n\nOutcomes will be assessed in all participating sites, and in among relevant performance subgroups (low performers, academic centers, full service, and among medication versus process metrics)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitals participating in the ACTION Registry GWTG\n\nExclusion Criteria:\n\n* sites with low volume of data submission (\\< 10 data forms in the past year)'}, 'identificationModule': {'nctId': 'NCT00952250', 'briefTitle': 'Targeted Feedback Reports to Improve Acute Coronary Syndromes (ACS) Care', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Personalized and Targeted Feedback in the ACTION-Registry-GWTG', 'orgStudyIdInfo': {'id': 'Pro00010526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Targeted Feedback Reports', 'description': 'Conventional feedback reports', 'interventionNames': ['Behavioral: Targeted Feedback Reports']}, {'type': 'EXPERIMENTAL', 'label': 'Targeted Feedback Report', 'description': 'Report designed to target areas for local hospital-specific improvement.', 'interventionNames': ['Behavioral: Targeted Feedback Report']}], 'interventions': [{'name': 'Targeted Feedback Reports', 'type': 'BEHAVIORAL', 'description': 'Sites randomized to this arm will receive specialized feedback summarizing their adherence to the guidelines and suggestions on ways to improve performance.', 'armGroupLabels': ['Targeted Feedback Reports']}, {'name': 'Targeted Feedback Report', 'type': 'BEHAVIORAL', 'description': 'Report designed to target areas for local hospital-specific improvement', 'armGroupLabels': ['Targeted Feedback Report']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Karen P Alexander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}