[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642274":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":119,"collaborators":12,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":12,"enrollmentInfo":132,"targetDuration":12,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":143,"overallStatus":150,"whyStopped":12,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","NO_INTERVENTION","Participants receive standard thrombosis clinic care and clinician-patient discussions regarding continuation versus discontinuation of anticoagulation following a first unprovoked or weakly provoked venous thromboembolism. No structured patient decision aid is used.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"DECIDE-VTE Patient Decision Aid","EXPERIMENTAL","Participants receive the DECIDE-VTE Patient Decision Aid in addition to usual thrombosis clinic care. The decision aid provides evidence-based information regarding the risks and benefits of continuing versus discontinuing anticoagulation after a first unprovoked or weakly provoked venous thromboembolism and includes a structured values clarification exercise to support shared decision-making. Participants and clinicians make the final treatment decision together during the Decision Visit.",[18],"Behavioral: DECIDE-VTE Patient Decision Aid",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"BEHAVIORAL","The DECIDE-VTE Patient Decision Aid is a bilingual (English\u002FFrench) evidence-based decision support tool designed for adults with a first unprovoked or weakly provoked venous thromboembolism who are deciding whether to continue or discontinue anticoagulation after completing at least 3 months of therapy. The decision aid presents balanced information regarding the risks and benefits of extended anticoagulation, including risks of recurrent venous thromboembolism and major bleeding, and incorporates a structured values clarification exercise to support shared decision-making between patients and clinicians during the anticoagulation Decision Visit.",[14],[25],{"name":26,"affiliation":27,"role":28},"Marc Rodger, MD MSc FRCPC","McGill University","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Harika Dasari","CONTACT","5144319353","harika.dasari@rimuhc.ca",[36,56,74,92,108],{"facility":37,"status":12,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Calgary","Calgary","Alberta","T2N 1N4","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-114.08529,51.05011,{"lat":47,"lon":46},[50,54],{"name":51,"role":32,"phone":52,"phoneExt":12,"email":53},"Jill Baxter","403-944-5246","jbaxter@ucalgary.ca",{"name":55,"role":28,"phone":12,"phoneExt":12,"email":12},"Leslie Skieth, MD FRCPC",{"facility":57,"status":12,"city":58,"state":59,"zip":60,"country":41,"countryCode":42,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Vancouver General Hospital","Vancouver","British Columbia","V5Z 1N1",{"type":44,"coordinates":62},[63,64],-123.11934,49.24966,{"lat":64,"lon":63},[67,72],{"name":68,"role":32,"phone":69,"phoneExt":70,"email":71},"Edward Wong","604-875-4111","22966","edward.wong@bccancer.bc.ca",{"name":73,"role":28,"phone":12,"phoneExt":12,"email":12},"Rick Ikesaka, MD MSc. FRCPC DRCPSC",{"facility":75,"status":12,"city":76,"state":77,"zip":78,"country":41,"countryCode":42,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Ottawa Hospital - General Campus","Ottawa","Ontario","K1H 8L6",{"type":44,"coordinates":80},[81,82],-75.69812,45.41117,{"lat":82,"lon":81},[85,90],{"name":86,"role":32,"phone":87,"phoneExt":88,"email":89},"Amanda Pecarskie","6137378899","78804","apecarskie@ohri.ca",{"name":91,"role":28,"phone":12,"phoneExt":12,"email":12},"Deborah Siegal, MD MSc FRCPC",{"facility":93,"status":12,"city":94,"state":95,"zip":96,"country":41,"countryCode":42,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Sir Mortimer B. Davis Jewish General Hospital","Montreal","Quebec","H3T 1E2",{"type":44,"coordinates":98},[99,100],-73.58781,45.50884,{"lat":100,"lon":99},[103],{"name":104,"role":32,"phone":105,"phoneExt":106,"email":107},"Elena Shulikovsky","514-340-8222","23703","eshulikovsky@jgh.mcgill.ca",{"facility":109,"status":12,"city":94,"state":95,"zip":110,"country":41,"countryCode":42,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Research Institute of McGill University Health Centre","H4A 3J1",{"type":44,"coordinates":112},[99,100],{"lat":100,"lon":99},[115],{"name":116,"role":32,"phone":117,"phoneExt":12,"email":118},"Sidra Ahmed","514-934-1934","Sidra.Ahmed@rimuhc.ca",{"type":28,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Marc Rodger","Professor, Department of Medicine","100642274","decision-aid-for-anticoagulation-duration-after-unprovoked-venous-thromboembolism-100642274",false,"NCT07659106","Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism","Enabling and Engaging Patients to Decide Indefinite Versus Short-Term Anticoagulation for Venous Thromboembolism (DECIDE-VTE)","DECIDE-VTE","Inclusion Criteria:\n\n* Age 18 years or older\n* First episode of objectively confirmed unprovoked or weakly provoked venous thromboembolism (VTE)\n* Objectively confirmed proximal deep vein thrombosis and\u002For segmental or greater pulmonary embolism\n* Completed at least 3 months of therapeutic anticoagulation and currently receiving anticoagulation\n* Enrollment within 12 months of diagnosis of the index\u002Fqualifying VTE event\n* Able to provide written informed consent\n* Able to participate in shared decision-making in English or French\n\nExclusion Criteria:\n\n* Recurrent unprovoked or weakly provoked VTE I(i.e. multiple unprovoked\u002Fweakly provoked VTE)\n* Index\u002Fqualifying VTE is a strongly provoked VTE (e.g., associated with major surgery, major trauma, plaster cast immobilization, or prolonged bed rest)\n* Index\u002Fqualifying VTE associated with a persistent strong provoking risk factor (e.g., active cancer or ongoing immobility)\n* Women at very low recurrence risk (HERDOO2 score 0-1)\n* High bleeding risk such that anticoagulation should be discontinued\n* Requirement for long-term anticoagulation for another indication (e.g., atrial fibrillation)\n* Prior dedicated long-term anticoagulation Decision Visit regarding anticoagulation duration","ALL","18 Years",{"count":133,"type":134},850,"ESTIMATED","INTERVENTIONAL",[137],"NA","Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, is a common condition that is typically treated with blood thinners (anticoagulants). After completing at least 3 months of treatment for a first unprovoked or weakly provoked VTE, patients and clinicians must decide whether to stop anticoagulation or continue treatment for a longer period. Continuing anticoagulation reduces the risk of another blood clot but increases the risk of bleeding. Because both options involve important benefits and risks, this decision should reflect the patient's values and preferences.\n\nThe DECIDE-VTE study will evaluate whether a patient decision aid can improve decision-making for patients facing this choice. The decision aid provides evidence-based information about the risks and benefits of continuing versus stopping anticoagulation and includes a values clarification exercise to help patients identify what matters most to them.\n\nThis multicentre batched stepped-wedge cluster randomized trial will be conducted in 12 thrombosis clinics across Canada. Clinics will transition from usual care to implementation of the patient decision aid according to a randomized schedule. The primary outcome is decisional conflict immediately following the anticoagulation decision visit, measured using the Decisional Conflict Scale. Secondary outcomes include patient knowledge, treatment decisions, decisional regret, concordance with the chosen treatment strategy, recurrent venous thromboembolism, major bleeding, all-cause mortality, and implementation outcomes.",[140,141,142],"Venous Thromboembolism (VTE)","Deep Vein Thrombosis (DVT)","Pulmonary Embolism",[144,145,146,147,148,149],"Anticoagulation","Patient Decision Aid","Shared Decision Making","Extended Anticoagulation","Decisional Conflict","Stepped-Wedge Cluster Randomized Trial","NOT_YET_RECRUITING","2026-06-19",{"date":153,"type":154},"2026-06-24","ACTUAL",{"date":156,"type":134},"2026-09",{"date":158,"type":134},"2029-03",{"name":5,"class":6},5]