Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-22 @ 10:00 AM
Study NCT ID:
NCT02046902
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2014-01-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'c1decker@saint-lukes.org', 'phone': '(816) 932-5440', 'title': 'Carole Decker', 'organization': "Saint Luke's Mid America Heart Institute"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The lack of randomization, availability of ePrism at hospitals, estimation of TVR risk in the SDM tool without the availability of angiographic data, and physicians were not surveyed for additional variables that impacted their stent selection.'}}, 'adverseEventsModule': {'description': 'There was not a Data Safety Monitoring Board as this was deemed low risk and no Serious, and Other \\[Not Including Serious\\] Adverse Events were monitored/recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-Implementation', 'description': 'Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Post-implementation With Decision Coaching', 'description': 'Patients received the consent form, the SDM tool for stent selection, and decision coaching', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Post-implementation Without Decision Coaching', 'description': 'Patients received the consent form and the SDM tool, but no decision coaching', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-Implementation', 'description': 'Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.'}, {'id': 'OG001', 'title': 'Post-implementation With Decision Coaching', 'description': 'Patients received the consent form, the SDM tool for stent selection, and decision coaching'}, {'id': 'OG002', 'title': 'Post-implementation Without Decision Coaching', 'description': 'Patients received the consent form and the SDM tool, but no decision coaching'}], 'classes': [{'categories': [{'title': 'Doctor Alone', 'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}, {'title': 'Mostly Doctor', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}, {'title': 'Doctor and you equally', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': 'Mostly you', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'You alone', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 months', 'description': 'The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than "doctor alone" in response to the question "Who chose the type of stent?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-Implementation', 'description': 'Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.'}, {'id': 'OG001', 'title': 'Post-implementation With Decision Coaching', 'description': 'Patients received the consent form, the SDM tool for stent selection, and decision coaching'}, {'id': 'OG002', 'title': 'Post-implementation Without Decision Coaching', 'description': 'Patients received the consent form and the SDM tool, but no decision coaching'}], 'classes': [{'categories': [{'title': 'Drug eluting stent', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}, {'title': 'Bare metal stent', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': "I don't care", 'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}, {'title': "I don't know", 'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 months', 'description': 'Secondary outcomes included patients\' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than "I don\'t care" or "I don\'t know" in response to the question "After reviewing the risks and benefits of both types of stents, which type of stent did you want?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-Implementation', 'description': 'Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.'}, {'id': 'FG001', 'title': 'Post-implementation With Decision Coaching', 'description': 'Patients received the consent form, the SDM tool for stent selection, and decision coaching'}, {'id': 'FG002', 'title': 'Post-implementation Without Decision Coaching', 'description': 'Patients received the consent form and the SDM tool, but no decision coaching'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Between May 2014 and December 2016, patients were recruited from 2 percutaneous coronary intervention (PCI) centers, Saint Luke's Mid America Heart Institute (MAHI) and Truman Medical Center (TMC), following institutional review board (IRB) approval at each site."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '586', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre-Implementation', 'description': 'Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching.'}, {'id': 'BG001', 'title': 'Post-implementation With Decision Coaching', 'description': 'Patients received the consent form, the SDM tool for stent selection, and decision coaching'}, {'id': 'BG002', 'title': 'Post-implementation Without Decision Coaching', 'description': 'patients received the consent form and the SDM tool, but no decision coaching'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '583', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '66.1', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '67.6', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '68.6', 'spread': '11.6', 'groupId': 'BG002'}, {'value': '67.43', 'spread': '12.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '506', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '325', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}, {'value': '574', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '457', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '535', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}, {'title': 'Site', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '586', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Mid America Heart Insitute', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '409', 'groupId': 'BG003'}]}, {'title': 'Truman Medical Center/Univ. of Missouri KC', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '579', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '270', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '586', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '464', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Peripheral arterial disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '565', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}, {'title': 'Prior Coronary Artery Bypass Graft', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}, {'value': '574', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}, {'title': 'Prior Percutaneous Coronary Intervention', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '579', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}, {'title': 'Admission Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '566', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Inpatient', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}, {'title': 'Outpatient', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '327', 'groupId': 'BG003'}]}, {'title': 'Emergent', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data.'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 586}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2014-01-22', 'resultsFirstSubmitDate': '2018-04-19', 'studyFirstSubmitQcDate': '2014-01-24', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-17', 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching', 'timeFrame': '30 months', 'description': 'The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than "doctor alone" in response to the question "Who chose the type of stent?"'}], 'secondaryOutcomes': [{'measure': 'Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.', 'timeFrame': '30 months', 'description': 'Secondary outcomes included patients\' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than "I don\'t care" or "I don\'t know" in response to the question "After reviewing the risks and benefits of both types of stents, which type of stent did you want?"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'cardiac stent', 'PCI procedure', 'Patient preference'], 'conditions': ['Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '30764654', 'type': 'DERIVED', 'citation': 'Chhatriwalla AK, Decker C, Gialde E, Catley D, Goggin K, Jaschke K, Jones P, deBronkart D, Sun T, Spertus JA. Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in Percutaneous Coronary Intervention Using a Pre-Post Study Design. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e005139. doi: 10.1161/CIRCOUTCOMES.118.005139.'}, {'pmid': '28168845', 'type': 'DERIVED', 'citation': "Qintar M, Chhatriwalla AK, Arnold SV, Tang F, Buchanan DM, Shafiq A, Pokharel Y, deBronkart D, Ashraf JM, Spertus JA. Beyond restenosis: Patients' preference for drug eluting or bare metal stents. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):357-363. doi: 10.1002/ccd.26946. Epub 2017 Feb 7."}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing PCI.", 'detailedDescription': "Study Plan: Qualitative research methods (focus groups) will be used to gather the information that would be helpful in decision making as well as review several possible output formats. Several sets of focus groups will be convened, with particular attention to recruitment of a diverse population, including women and underserved minority groups.\n\nStudy Procedure: We will gather input to create a clinically useful format for presenting the risk estimates for desired outcomes and support clinical decision-making.\n\nSubjects: We anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus groups of 3-5 individuals will be scheduled. Fliers will be posted to enlist potential patients. If necessary, patients will also be contacted by a Cardiovascular Research Coordinator and invited to attend a scheduled focus group. After receiving patient/family/caregiver input, selected clinicians from the Saint Lukes Hospital Staff, including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend a scheduled focus group. The invitation will be sent via email and followed up with a phone call, if necessary. If a clinician focus group is unable to be scheduled, then individual interviews will be conducted.\n\nSetting: Patient and Clinician focus group sessions will be held at Saint Luke's Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with and without coronary artery disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* English or Spanish speaking\n* Presence of coronary disease, or a caregiver/relative of one with coronary disease\n\nExclusion Criteria:\n\n* non-English or non-Spanish speaking\n* dementia'}, 'identificationModule': {'nctId': 'NCT02046902', 'acronym': 'DECIDE-PCI', 'briefTitle': 'Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri, Kansas City'}, 'officialTitle': 'Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection', 'orgStudyIdInfo': {'id': 'CE-1304-6448'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart disease', 'description': 'Adults with a diagnosis of coronary artery disease and may have had a percutaneous coronary intervention.'}, {'label': 'Healthy adults', 'description': 'Adults without a diagnosis of coronary artery disease. Focus groups will be held.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Truman Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'John A Spertus, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri, Kansas City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We would be happy to collaborate with others to run analyses, but do not plan on freely distributing our data. You can see my editorial in CCQO to understand my concerns.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri, Kansas City', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Daniel Lauer/Missouri Endowed Chair', 'investigatorFullName': 'John A. Spertus', 'investigatorAffiliation': 'University of Missouri, Kansas City'}}}}