Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-01-27 @ 5:57 PM
Study NCT ID:
NCT03021759
Status:
COMPLETED
Last Update Posted:
2019-06-20
First Post:
2017-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peper@pennmedicine.upenn.edu', 'phone': '215-360-0951', 'title': 'Rebecca Pepe', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Physicians and patients were from a single health care system and we did not have data on prescription fill rates.'}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'No intervention', 'otherNumAtRisk': 1566, 'deathsNumAtRisk': 1566, 'otherNumAffected': 0, 'seriousNumAtRisk': 1566, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Choice', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.\n\nActive choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin', 'otherNumAtRisk': 1743, 'deathsNumAtRisk': 1743, 'otherNumAffected': 0, 'seriousNumAtRisk': 1743, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Active Choice With Social Comparison Feedback', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers\n\nActive choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin\n\nSocial comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers', 'otherNumAtRisk': 1465, 'deathsNumAtRisk': 1465, 'otherNumAffected': 0, 'seriousNumAtRisk': 1465, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Statin Prescribing Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1566', 'groupId': 'OG000'}, {'value': '1743', 'groupId': 'OG001'}, {'value': '1465', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'No intervention'}, {'id': 'OG001', 'title': 'Active Choice', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.\n\nActive choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin'}, {'id': 'OG002', 'title': 'Active Choice With Social Comparison Feedback', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers\n\nActive choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin\n\nSocial comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Two Months', 'description': 'Percentage of patients eligible for a statin that have been prescribed a statin', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'No intervention'}, {'id': 'FG001', 'title': 'Active Choice', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.\n\nActive choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin'}, {'id': 'FG002', 'title': 'Active Choice With Social Comparison Feedback', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers\n\nActive choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin.\n\nSocial comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1566'}, {'groupId': 'FG001', 'numSubjects': '1743'}, {'groupId': 'FG002', 'numSubjects': '1465'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '32 primary care physicians were randomized to this arm and analyzed.', 'groupId': 'FG000', 'numSubjects': '1566'}, {'comment': '32 primary care physicians were randomized to this arm and analyzed.', 'groupId': 'FG001', 'numSubjects': '1743'}, {'comment': '32 primary care physicians were randomized to this arm and analyzed.', 'groupId': 'FG002', 'numSubjects': '1465'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'No informed consent was obtained from the participants in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1566', 'groupId': 'BG000'}, {'value': '1743', 'groupId': 'BG001'}, {'value': '1465', 'groupId': 'BG002'}, {'value': '4774', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'No intervention'}, {'id': 'BG001', 'title': 'Active Choice', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.\n\nActive choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin'}, {'id': 'BG002', 'title': 'Active Choice With Social Comparison Feedback', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers\n\nActive choice: Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin\n\nSocial comparison feedback: Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '62.4', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '62.4', 'spread': '8.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '738', 'groupId': 'BG000'}, {'value': '710', 'groupId': 'BG001'}, {'value': '701', 'groupId': 'BG002'}, {'value': '2149', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '828', 'groupId': 'BG000'}, {'value': '1033', 'groupId': 'BG001'}, {'value': '764', 'groupId': 'BG002'}, {'value': '2625', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White non-Hispanic', 'categories': [{'measurements': [{'value': '1004', 'groupId': 'BG000'}, {'value': '1110', 'groupId': 'BG001'}, {'value': '926', 'groupId': 'BG002'}, {'value': '3040', 'groupId': 'BG003'}]}]}, {'title': 'Black non-Hispanic', 'categories': [{'measurements': [{'value': '420', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}, {'value': '1318', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '416', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Annual Household Income', 'classes': [{'categories': [{'title': '<50,000 US$', 'measurements': [{'value': '435', 'groupId': 'BG000'}, {'value': '563', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}, {'value': '1404', 'groupId': 'BG003'}]}, {'title': '50,000 - 100,000 US$', 'measurements': [{'value': '784', 'groupId': 'BG000'}, {'value': '960', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}, {'value': '2477', 'groupId': 'BG003'}]}, {'title': '>100,000 US$', 'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}, {'value': '859', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-01', 'size': 158524, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-30T14:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4774}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-20', 'studyFirstSubmitDate': '2017-01-12', 'resultsFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2017-01-13', 'lastUpdatePostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-20', 'studyFirstPostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Statin Prescribing Rate', 'timeFrame': 'Two Months', 'description': 'Percentage of patients eligible for a statin that have been prescribed a statin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '30646039', 'type': 'DERIVED', 'citation': 'Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, Leri D, Rareshide CAL, Day SC, Mahoney KB, Volpp KG, Asch DA. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180818. doi: 10.1001/jamanetworkopen.2018.0818.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled trial to evaluate an active choice intervention with and without social comparison feedback to increase physician statin prescribing rates for eligible patients.', 'detailedDescription': 'Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Strong evidence indicates that statin medications can reduce the risk of CVD and for those with CVD statins have been shown to reduce mortality. Despite this evidence, statins are under-prescribed. In this study, the investigators will test the effectiveness of nudges targeted to physicians using active choice and social comparisons feedback to increasing the rate at which statin medications are prescribed to patients eligible based on national practice guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a primary care physician at University of Pennsylvania Health System\n* Patient meets 2013 AHA/ACC guidelines for statin therapy but no record of a statin prescription in the electronic health record\n\nExclusion Criteria:\n\n* Patient has an allergy or adverse reaction to statins documented in the electronic health record\n* Patient has glomerular filtration rate less than 30 mL/min\n* Physicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin'}, 'identificationModule': {'nctId': 'NCT03021759', 'acronym': 'PRESCRIBE', 'briefTitle': 'Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence', 'orgStudyIdInfo': {'id': '826125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Active choice', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin.', 'interventionNames': ['Behavioral: Active choice']}, {'type': 'EXPERIMENTAL', 'label': 'Active choice with social comparison feedback', 'description': 'Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers', 'interventionNames': ['Behavioral: Active choice', 'Behavioral: Social comparison feedback']}], 'interventions': [{'name': 'Active choice', 'type': 'BEHAVIORAL', 'description': 'Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin', 'armGroupLabels': ['Active choice', 'Active choice with social comparison feedback']}, {'name': 'Social comparison feedback', 'type': 'BEHAVIORAL', 'description': 'Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers', 'armGroupLabels': ['Active choice with social comparison feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Mitesh Patel, MD, MBA, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}