Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-02 @ 1:17 PM
Study NCT ID:
NCT01002456
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2009-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'madeline.mccarren@va.gov', 'phone': '708 786 7987', 'title': 'Dr. Madeline McCarren', 'organization': 'Dept. of Veterans Affairs'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Level 1: Provide Site-specific Information', 'description': 'Level 1: provide site-specific information on non-adherence', 'otherNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Level 2: Provide Site- and Patient-specific Information', 'description': 'Level 2: provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions', 'otherNumAtRisk': 122, 'otherNumAffected': 0, 'seriousNumAtRisk': 122, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Adherence to Guideline Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Level 1', 'description': 'provide site-specific information'}, {'id': 'OG001', 'title': 'Level 2', 'description': 'provide site- and patient-specific information'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.1', 'ciUpperLimit': '3.2', 'estimateComment': 'Proportional odds ratio to measure the trend of change in concordance with guideline recommendations, with Arm 1 as the comparator.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'full adherence to guideline medication and dose', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progress Toward Adherence to Guideline Prescription', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Level 1: Provide Site-specific Information', 'description': 'Level 1: provide site-specific information on nonadherence'}, {'id': 'OG001', 'title': 'Level 2:Provide Site- and Patient-specific Information', 'description': 'Level 2:provide site- and patient-specific information on nonadherence'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'either change to a guideline agent or dose increase of a guideline agent', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1', 'description': 'provide site-specific information\n\nLevel 1 (Provide site-specific information): provide site-specific information on non-adherence to guideline'}, {'id': 'FG001', 'title': 'Arm 2', 'description': 'provide site- and patient-specific information\n\nLevel 2 (Provide site- and patient-specific information): provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Level 1', 'description': 'site-specific information provided'}, {'id': 'BG001', 'title': 'Level 2', 'description': 'site- and patient-specific information provided'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '71', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '71', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'patients'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2009-10-23', 'resultsFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2009-10-26', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-08', 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Adherence to Guideline Prescription', 'timeFrame': '6 months', 'description': 'full adherence to guideline medication and dose'}], 'secondaryOutcomes': [{'measure': 'Progress Toward Adherence to Guideline Prescription', 'timeFrame': '6 months', 'description': 'either change to a guideline agent or dose increase of a guideline agent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adrenergic beta-Antagonists', 'Guideline Adherence', 'Drug Prescriptions', 'target dose'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The overall objective of the proposed pilot study is to begin evaluation of two methods for promoting adherence to guidelines for beta-blocker therapy in heart failure. The design includes site level baseline measurement, feedback, remeasurement after six months, and randomized (by site) comparison samples. The setting is VA sites, with intervention directed at the pharmacy.', 'detailedDescription': 'Current evidence-based guidelines in VA recommend one of three beta-blockers (carvedilol, metoprolol succinate, or bisoprolol) that have been shown to reduce mortality in heart failure patients with systolic dysfunction, with recommended target doses. However, Pharmacy Benefits Management (PBM) data indicate that prescribing for beta-blockers in heart failure patients that is not in accordance with guidelines is substantial, both in terms of the agent selected and the dose. Sites will be recruited and randomized to two different intensities of intervention to promote adherence to guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* VA sites\n* Males and females\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT01002456', 'briefTitle': 'Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison', 'orgStudyIdInfo': {'id': 'RRP 09-136'}, 'secondaryIdInfos': [{'id': 'VMS #120', 'type': 'OTHER', 'domain': 'PBM VAMedSAFE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Level 1: site-specific information', 'description': 'provide site-specific information on nonadherence', 'interventionNames': ['Other: Level 1: (provide site-specifi information)']}, {'type': 'OTHER', 'label': 'Level 2: site-, patient-specific info', 'description': 'provide site- and patient-specific information on nonadherence', 'interventionNames': ['Other: Level 2 (Provide site- and patient-specific information)']}], 'interventions': [{'name': 'Level 1: (provide site-specifi information)', 'type': 'OTHER', 'description': 'provide site-specific information on non-adherence to guideline', 'armGroupLabels': ['Level 1: site-specific information']}, {'name': 'Level 2 (Provide site- and patient-specific information)', 'type': 'OTHER', 'description': 'provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions', 'armGroupLabels': ['Level 2: site-, patient-specific info']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60141-5000', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines Jr. VA Hospital, Hines, IL', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}], 'overallOfficials': [{'name': 'Madeline McCarren, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edward Hines Jr. VA Hospital, Hines, IL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}