Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-01 @ 4:31 PM
Study NCT ID:
NCT02905032
Status:
COMPLETED
Last Update Posted:
2022-01-25
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SDM for Stroke Prevention in Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006379', 'term': 'Helping Behavior'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Noseworthy.Peter@mayo.edu', 'phone': '507-255-2446', 'title': 'Peter A. Noseworthy, M.D.', 'organization': 'Mayo Clinci'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from baseline to end of study, approximately 12 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Care', 'description': 'Observations were in the clinical encounter via video, audio or observational notes.', 'otherNumAtRisk': 459, 'deathsNumAtRisk': 459, 'otherNumAffected': 0, 'seriousNumAtRisk': 459, 'deathsNumAffected': 19, 'seriousNumAffected': 52}, {'id': 'EG001', 'title': 'Standard Care + Decision Aid', 'description': 'Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.\n\nDecision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.', 'otherNumAtRisk': 463, 'deathsNumAtRisk': 463, 'otherNumAffected': 0, 'seriousNumAtRisk': 463, 'deathsNumAffected': 15, 'seriousNumAffected': 52}, {'id': 'EG002', 'title': 'Clinicians', 'description': 'Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites', 'otherNumAtRisk': 244, 'deathsNumAtRisk': 244, 'otherNumAffected': 0, 'seriousNumAtRisk': 244, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 463, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 244}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 459, 'numEvents': 63, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 463, 'numEvents': 61, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 244}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Clinician Satisfied Encounters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Observations were in the clinical encounter via video, audio or observational notes.'}, {'id': 'OG001', 'title': 'Standard Care + Decision Aid', 'description': 'Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.\n\nDecision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '277', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'The number of encounters that the clinicians were satisfied with the decision-making process. The results reported for this Outcome Measure reflect the response of the clinician for each patient. A 5 point likert scale questioning satisfaction with discussion about anticoagulation medication choice. The 5 point likert scale ranges from 1-5, with 1 being not at all satisfied and 5 being completely satisfied. Any values of 4 or 5 were considered to be satisfied.', 'unitOfMeasure': 'encounters', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed nor collected for 11 subjects in Standard Care arm. Data was not analyzed nor collected for 10 subjects in Standard Care + Decision Aid arm'}, {'type': 'PRIMARY', 'title': 'Number of Clinician Recommendation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Observations were in the clinical encounter via video, audio or observational notes.'}, {'id': 'OG001', 'title': 'Standard Care + Decision Aid', 'description': 'Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.\n\nDecision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'The number of encounters were the clinician would recommend the decision making process approach. The results reported for this Outcome Measure reflect the response of the clinician for each patient. Clinician was asked whether they would recommend the approached used to other clinician for other discussions on a 7 point Likert scale. The 7 point likert scale ranges from 1-7, with 1 being no I would strongly recommend against it and 7 being yes I would strongly recommend it. Any values of 6 or 7 were considered to be clinician would recommend.', 'unitOfMeasure': 'encounters', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed nor collected for 11 subjects in Standard Care arm. Data was not analyzed nor collected for 10 subjects in Standard Care + Decision Aid arm'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anticoagulant Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Observations were in the clinical encounter via video, audio or observational notes.'}, {'id': 'OG001', 'title': 'Standard Care + Decision Aid', 'description': 'Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.\n\nDecision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The number of subjects who chose to start or continue receive an anticoagulant medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Involvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Observations were in the clinical encounter via video, audio or observational notes.'}, {'id': 'OG001', 'title': 'Standard Care + Decision Aid', 'description': 'Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.\n\nDecision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '33.0', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Patient involvement in decision-making as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale. The 12 items measure observed patient involvement. Each of the 12 items have possible scores that range from 0 (the behavior is not observed) to 4 (the behavior is exhibited to a very high standard). To calculate the total score for each patient, the 12 items are summed, divided by 48 (the maximum possible score), and multiplied by 100. Total score minimum is 0, maximum is 100. The higher the total score the higher the patient involvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed nor collected for 48 subjects in Standard Care arm. Data was not analyzed nor collected for 44 subjects in Standard Care + Decision Aid arm'}, {'type': 'SECONDARY', 'title': 'Encounter Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Observations were in the clinical encounter via video, audio or observational notes.'}, {'id': 'OG001', 'title': 'Standard Care + Decision Aid', 'description': 'Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.\n\nDecision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '17', 'groupId': 'OG000'}, {'value': '32', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'The length of time for the subjects visit with the clinician, as measured in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed nor collected for 48 subjects in Standard Care arm. Data was not analyzed nor collected for 44 subjects in Standard Care + Decision Aid arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Care', 'description': 'Observations were in the clinical encounter via video, audio or observational notes.'}, {'id': 'FG001', 'title': 'Standard Care + Decision Aid', 'description': 'Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.\n\nDecision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.'}, {'id': 'FG002', 'title': 'Clinicians', 'description': 'Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '467'}, {'groupId': 'FG001', 'numSubjects': '475'}, {'groupId': 'FG002', 'numSubjects': '244'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '459'}, {'groupId': 'FG001', 'numSubjects': '463'}, {'groupId': 'FG002', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Care', 'description': 'Observations were in the clinical encounter via video, audio or observational notes.'}, {'id': 'BG001', 'title': 'Standard Care + Decision Aid', 'description': 'Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.\n\nDecision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.'}, {'id': 'BG002', 'title': 'Clinicians', 'description': 'Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}, {'value': '1144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '71', 'spread': '10', 'groupId': 'BG000'}, {'value': '71', 'spread': '11', 'groupId': 'BG001'}, {'value': '42', 'spread': '12', 'groupId': 'BG002'}, {'value': '65', 'spread': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Did not collect the age for 22 Clinicians'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}, {'value': '1144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '475', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '669', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Did not collect the gender for 22 Clinicians'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '380', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '767', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '459', 'groupId': 'BG000'}, {'value': '463', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '1166', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-12', 'size': 448380, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-09T14:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-29', 'studyFirstSubmitDate': '2016-09-09', 'resultsFirstSubmitDate': '2021-11-11', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-29', 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Clinician Satisfied Encounters', 'timeFrame': '1 month', 'description': 'The number of encounters that the clinicians were satisfied with the decision-making process. The results reported for this Outcome Measure reflect the response of the clinician for each patient. A 5 point likert scale questioning satisfaction with discussion about anticoagulation medication choice. The 5 point likert scale ranges from 1-5, with 1 being not at all satisfied and 5 being completely satisfied. Any values of 4 or 5 were considered to be satisfied.'}, {'measure': 'Number of Clinician Recommendation', 'timeFrame': '1 month', 'description': 'The number of encounters were the clinician would recommend the decision making process approach. The results reported for this Outcome Measure reflect the response of the clinician for each patient. Clinician was asked whether they would recommend the approached used to other clinician for other discussions on a 7 point Likert scale. The 7 point likert scale ranges from 1-7, with 1 being no I would strongly recommend against it and 7 being yes I would strongly recommend it. Any values of 6 or 7 were considered to be clinician would recommend.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Anticoagulant Medication Use', 'timeFrame': '12 months', 'description': 'The number of subjects who chose to start or continue receive an anticoagulant medication.'}, {'measure': 'Patient Involvement', 'timeFrame': '1 month', 'description': 'Patient involvement in decision-making as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale. The 12 items measure observed patient involvement. Each of the 12 items have possible scores that range from 0 (the behavior is not observed) to 4 (the behavior is exhibited to a very high standard). To calculate the total score for each patient, the 12 items are summed, divided by 48 (the maximum possible score), and multiplied by 100. Total score minimum is 0, maximum is 100. The higher the total score the higher the patient involvement.'}, {'measure': 'Encounter Duration', 'timeFrame': '1 month', 'description': 'The length of time for the subjects visit with the clinician, as measured in minutes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Afib', 'Atrial fib', 'Shared', 'Decision', 'Making', 'Aid', 'AF'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '35962351', 'type': 'DERIVED', 'citation': 'Sivly A, Gorr HS, Gravholt D, Branda ME, Linzer M, Noseworthy P, Hargraves I, Kunneman M, Doubeni CA, Suzuki T, Brito JP, Jackson EA, Burnett B, Wambua M, Montori VM; Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial. BMC Health Serv Res. 2022 Aug 12;22(1):1032. doi: 10.1186/s12913-022-08399-z.'}, {'pmid': '35023356', 'type': 'DERIVED', 'citation': 'Noseworthy PA, Branda ME, Kunneman M, Hargraves IG, Sivly AL, Brito JP, Burnett B, Zeballos-Palacios C, Linzer M, Suzuki T, Lee AT, Gorr H, Jackson EA, Hess E, Brand-McCarthy SR, Shah ND, Montori VM; SDM4AFib (Shared Decision-Making for Atrial Fibrillation) Trial Investigators *. Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial. J Am Heart Assoc. 2022 Jan 18;11(2):e023048. doi: 10.1161/JAHA.121.023048. Epub 2022 Jan 13.'}, {'pmid': '34255051', 'type': 'DERIVED', 'citation': 'Kamath CC, Giblon R, Kunneman M, Lee AI, Branda ME, Hargraves IG, Sivly AL, Bellolio F, Jackson EA, Burnett B, Gorr H, Torres Roldan VD, Spencer-Bonilla G, Shah ND, Noseworthy PA, Montori VM, Brito JP; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Cost Conversations About Anticoagulation Between Patients With Atrial Fibrillation and Their Clinicians: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116009. doi: 10.1001/jamanetworkopen.2021.16009.'}, {'pmid': '32897386', 'type': 'DERIVED', 'citation': 'Kunneman M, Branda ME, Hargraves IG, Sivly AL, Lee AT, Gorr H, Burnett B, Suzuki T, Jackson EA, Hess E, Linzer M, Brand-McCarthy SR, Brito JP, Noseworthy PA, Montori VM; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Sep 1;180(9):1215-1224. doi: 10.1001/jamainternmed.2020.2908.'}, {'pmid': '32398149', 'type': 'DERIVED', 'citation': 'Spencer-Bonilla G, Thota A, Organick P, Ponce OJ, Kunneman M, Giblon R, Branda ME, Sivly AL, Behnken E, May CR, Montori VM; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Normalization of a conversation tool to promote shared decision making about anticoagulation in patients with atrial fibrillation within a practical randomized trial of its effectiveness: a cross-sectional study. Trials. 2020 May 12;21(1):395. doi: 10.1186/s13063-020-04305-2.'}, {'pmid': '28962662', 'type': 'DERIVED', 'citation': 'Kunneman M, Branda ME, Noseworthy PA, Linzer M, Burnett B, Dick S, Spencer-Bonilla G, Fernandez CA, Gorr H, Wambua M, Keune S, Zeballos-Palacios C, Hargraves I, Shah ND, Montori VM. Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial. Trials. 2017 Sep 29;18(1):443. doi: 10.1186/s13063-017-2178-y.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.', 'detailedDescription': 'The goal of this study is to determine the extent to which the Anticoagulation Choice tool promotes shared decision making and its impact on anticoagulation use and adherence versus standard care in patients with nonvalvular atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Clinician Inclusion Criteria:\n\n• All clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion\n\nPatient Inclusion Criteria:\n\n* ≥ 18 years of age\n* Chronic nonvalvular atrial fibrillation deemed at high risk of thromboembolic strokes (CHA2D2-VASc Score ≥ 1, or 2 in women)\n* Able to read and understand (despite cognitive, sensorial, hearing or language challenges) the informed consent document as determined by the study coordinator during consent\n\nPatient Exclusion Criteria:\n\n• Clinician indicates that patient is not a candidate for a discussion about anticoagulation medication'}, 'identificationModule': {'nctId': 'NCT02905032', 'acronym': 'SDM4Afib', 'briefTitle': 'SDM for Stroke Prevention in Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial', 'orgStudyIdInfo': {'id': '16-005409'}, 'secondaryIdInfos': [{'id': '1R01HL131535', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL131535', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Observations in clinical encounter via video, audio or observational notes.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care + Decision Aid', 'description': 'Observation of clinical encounter using the decision aid via video, audio, or observational notes.', 'interventionNames': ['Behavioral: Decision Aid']}], 'interventions': [{'name': 'Decision Aid', 'type': 'BEHAVIORAL', 'otherNames': ['DA'], 'description': 'Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.', 'armGroupLabels': ['Standard Care + Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Park Nicollet Health Partners', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Peter A Noseworthy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Park Nicollet Clinic', 'class': 'OTHER'}, {'name': 'Hennepin County Medical Center, Minneapolis', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Peter A. Noseworthy, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}