Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-02 @ 7:45 AM
Study NCT ID:
NCT02392104
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2015-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andrea.porter@wisc.edu', 'phone': '608-890-0742', 'title': 'Andrea Porter, PharmD', 'organization': 'William S. Middleton Memorial Veterans Hospital'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'Major bleeding was defined as a fatal or symptomatic bleed into a critical area or organ, bleeding leading to hospitalization, or transfusion of two units or more of packed red blood cells. This definition is the standard definition used by the Anticoagulation Clinic to report events.\n\nSerious bleeding was defined as bleeding leading to emergency or urgent care visit or additional testing required.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks.", 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 19, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Serious bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonic hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoidal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe AKI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RLE cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-op monitoring for vascular procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rates of Participant Accrual', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'classes': [{'title': 'Number of patients invted', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Patient enrolled in study', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Patients analyzed for study', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 2.25 years', 'description': 'Number of participants who enroll vs. number of individuals invited', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '107 invited to participate in the study, not all enrolled or started the study'}, {'type': 'PRIMARY', 'title': 'Number of Participants Able to be Scheduled for at Least One 12-week Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'This outcome will determine the number of participants able to be scheduled for at least one 12-week interval', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Frequency of Appointments From Baseline to End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'classes': [{'title': 'Planned anticoagulation visits (baseline)', 'categories': [{'measurements': [{'value': '12.67', 'spread': '2.56', 'groupId': 'OG000'}]}]}, {'title': 'Planned anticoagulation visits (0-12 months)', 'categories': [{'measurements': [{'value': '10.43', 'spread': '3.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 and 24 months', 'description': 'This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)', 'unitOfMeasure': 'visits per 12 months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '44 participants remained in the study at 12 months'}, {'type': 'SECONDARY', 'title': 'Bleeding and Thromboembolic Events From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'classes': [{'title': 'Number of thromboembolic events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Number of major bleeding events', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Number of serious bleeding events', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'This outcome will determine the number of bleeding and thromboembolic events from baseline', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Time in Therapeutic Range From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.2', 'spread': '26.4', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '18.3', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '13.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6, 12, and 24 months', 'description': 'The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)', 'unitOfMeasure': 'change in percentage of TTR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '49 participants at 12 months, 44 participants at 24 months'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction Through Total DASS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '42.89', 'spread': '12.08', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '43.99', 'spread': '11.75', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '38.83', 'spread': '11.53', 'groupId': 'OG000'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '46.82', 'spread': '15.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months, 12 months, 24 months', 'description': 'Patient satisfaction through total DASS score. DASS = Duke Anticoagulation Satisfaction Scale. 25-item scale.Higher numbers indicate worsening satisfaction ranging from 25-175. Seven-point ordinal scale ("not at all" = 1, "very much" = 7).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency and Type of Protocol Deviations From Both Participants and Study Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}, {'units': 'participant visits', 'counts': [{'value': '634', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'classes': [{'title': 'extended interval visits scheduled correctly', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}]}]}, {'title': 'Deviations too short', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Deviations too long', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2.25 years', 'description': 'This outcome determines the frequency and type of protocol deviations from both participants and study staff', 'unitOfMeasure': 'percentage of visits', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'participant visits', 'denomUnitsSelected': 'participant visits', 'populationDescription': '634 eligible participant visits'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extended INR Follow-up Interval Group', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'one participant enrolled but was removed prior to starting study protocol', 'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'discontinuation of warfarin', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'bleeding event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'transferred care to another doctor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'INR goal range changed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'admitted to skilled nursing facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'INRs drawn by visiting nurse services', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': "All patients in the study will be in the intervention arm.\n\nWarfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'spread': '7.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HAS-BLED score', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The HAS-BLED score evaluates a patient's bleeding risk. HAS-BLED is the official name of the tool to assess risk. Scores range from 0-9. Scores of 3 or higher indicate a high bleeding risk.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-18', 'size': 230956, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-16T15:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2015-02-25', 'resultsFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-21', 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frequency and Type of Protocol Deviations From Both Participants and Study Staff', 'timeFrame': 'Up to 2.25 years', 'description': 'This outcome determines the frequency and type of protocol deviations from both participants and study staff'}], 'primaryOutcomes': [{'measure': 'Rates of Participant Accrual', 'timeFrame': 'up to 2.25 years', 'description': 'Number of participants who enroll vs. number of individuals invited'}, {'measure': 'Number of Participants Able to be Scheduled for at Least One 12-week Interval', 'timeFrame': '24 months', 'description': 'This outcome will determine the number of participants able to be scheduled for at least one 12-week interval'}, {'measure': 'Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals', 'timeFrame': '24 months', 'description': 'The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals'}], 'secondaryOutcomes': [{'measure': 'Change in Frequency of Appointments From Baseline to End of Study', 'timeFrame': '12 and 24 months', 'description': 'This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)'}, {'measure': 'Bleeding and Thromboembolic Events From Baseline', 'timeFrame': '24 months', 'description': 'This outcome will determine the number of bleeding and thromboembolic events from baseline'}, {'measure': 'Change in Time in Therapeutic Range From Baseline', 'timeFrame': '6, 12, and 24 months', 'description': 'The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)'}, {'measure': 'Patient Satisfaction Through Total DASS Score', 'timeFrame': 'baseline, 6 months, 12 months, 24 months', 'description': 'Patient satisfaction through total DASS score. DASS = Duke Anticoagulation Satisfaction Scale. 25-item scale.Higher numbers indicate worsening satisfaction ranging from 25-175. Seven-point ordinal scale ("not at all" = 1, "very much" = 7).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['International Normalized Ratio', 'Warfarin'], 'conditions': ['Anticoagulation']}, 'referencesModule': {'references': [{'pmid': '31752504', 'type': 'DERIVED', 'citation': 'Schoen RR, Nagy MW, Porter AL, Margolis AR. Patient Satisfaction With Extended International Normalized Ratio Follow-up Intervals in a Veteran Population. Ann Pharmacother. 2020 May;54(5):442-449. doi: 10.1177/1060028019889414. Epub 2019 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility, safety, and acceptability of implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.\n\nAll participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol. Patient satisfaction will be evaluated at various points throughout the study. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.', 'detailedDescription': 'The purpose of this study is to determine the feasibility, safety, and acceptability of implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital.\n\nAll participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol, from 5-6 weeks, to 7-8 weeks, to 11-12 weeks and then continued with 11-12 week visits if INRs continue to remain in goal range and appropriate for the patient. Patient satisfaction will be evaluated at baseline, 6-, 12-, and 24-months. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* requirement for indefinite warfarin therapy\n* target INR of 2-3\n* stable weekly warfarin dose for the past 6 months (not more than a single, one-time adjustment (boost/omission) in the past 6 months, planned interruption for a procedure or surgery with INR(s) out of range in the past 6 months would not exclude a patient)\n* a patient of the Madison VA anticoagulation clinic for the previous 12 months\n\nExclusion Criteria:\n\n* consistently drink ≥4 alcoholic beverages/day or a documented episode of alcohol binging in the past 6 months\n* diagnosis of cancer and on active chemotherapy/radiotherapy in the past 3 months\n* life expectancy of \\< 1 year\n* enrolled in other investigational drug protocols\n* only receiving anticoagulation care at the Madison VA for part of the year (e.g. snowbirds)\n* receiving visiting nurse services for INR monitoring\n* thrombocytopenia (\\<100K) within past 12 months\n* history of bleeding or thromboembolism requiring medical intervention within past 6 months\n* treatment for active liver disease (e.g. hepatitis)\n* diagnosis or documentation in EMR suggesting cognitive impairment\n* activated power of attorney\n* inability to provide informed consent\n* non-English speaking\n* unstable mental health disorder that impairs judgment\n* history of non-adherence to anticoagulation clinic policies and procedures (i.e. missed appointments, self-adjustment of warfarin dose, nonadherence, etc.).'}, 'identificationModule': {'nctId': 'NCT02392104', 'briefTitle': 'Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service', 'organization': {'class': 'FED', 'fullName': 'William S. Middleton Memorial Veterans Hospital'}, 'officialTitle': 'Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service', 'orgStudyIdInfo': {'id': '2014-1296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'All patients in the study will be in the intervention arm.', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['Coumadin'], 'description': "If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks.", 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Carla Staresinic, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'William S. Middleton Memorial Veterans Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William S. Middleton Memorial Veterans Hospital', 'class': 'FED'}, 'collaborators': [{'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Manager, Anticoagulation Services', 'investigatorFullName': 'Carla Staresinic', 'investigatorAffiliation': 'William S. Middleton Memorial Veterans Hospital'}}}}