Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism (DECIDE-VTE)
Enabling and Engaging Patients to Decide Indefinite Versus Short-Term Anticoagulation for Venous Thromboembolism (DECIDE-VTE)
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.
The 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.
This 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, is commonly treated with anticoagulation. After completing initial anticoagulation for a first unprovoked or weakly provoked VTE, patients and clinicians must decide whether to discontinue anticoagulation or continue treatment long term. This is a preference-sensitive decision because continued anticoagulation reduces the risk of recurrent VTE but increases the risk of bleeding.
The DECIDE-VTE Patient Decision Aid was developed to support shared decision-making about anticoagulation duration. The tool provides structured information about treatment options, recurrence and bleeding risks, and includes a values-clarification exercise to help patients consider which outcomes and treatment burdens matter most to them.
This study is a pragmatic, multicentre, batched stepped-wedge cluster randomized trial. Participating thrombosis clinics begin in the usual care phase and transition to implementation of the DECIDE-VTE Patient Decision Aid according to a randomized schedule. Randomization occurs at the clinic level to reduce contamination between study conditions and to reflect real-world implementation of the decision aid into routine thrombosis clinic care.
The study will assess whether integrating the DECIDE-VTE Patient Decision Aid into clinical care improves decision quality compared with usual care, and will also evaluate implementation-related measures relevant to future use of the tool in practice.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Harika Dasari
- Número de teléfono: 5144319353
- Correo electrónico: harika.dasari@rimuhc.ca
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 1N4
- University Of Calgary
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Contacto:
- Jill Baxter
- Número de teléfono: 403-944-5246
- Correo electrónico: jbaxter@ucalgary.ca
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Investigador principal:
- Leslie Skieth, MD FRCPC
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1N1
- Vancouver General Hospital
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Contacto:
- Edward Wong
- Número de teléfono: 22966 604-875-4111
- Correo electrónico: edward.wong@bccancer.bc.ca
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Investigador principal:
- Rick Ikesaka, MD MSc. FRCPC DRCPSC
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- Ottawa Hospital - General Campus
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Contacto:
- Amanda Pecarskie
- Número de teléfono: 78804 6137378899
- Correo electrónico: apecarskie@ohri.ca
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Investigador principal:
- Deborah Siegal, MD MSc FRCPC
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Quebec
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Montreal, Quebec, Canadá, H3T 1E2
- Sir Mortimer B. Davis Jewish General Hospital
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Contacto:
- Elena Shulikovsky
- Número de teléfono: 23703 514-340-8222
- Correo electrónico: eshulikovsky@jgh.mcgill.ca
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Montreal, Quebec, Canadá, H4A 3J1
- Research Institute of McGill University Health Centre
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Contacto:
- Sidra Ahmed
- Número de teléfono: 514-934-1934
- Correo electrónico: Sidra.Ahmed@rimuhc.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- First episode of objectively confirmed unprovoked or weakly provoked venous thromboembolism (VTE)
- Objectively confirmed proximal deep vein thrombosis and/or segmental or greater pulmonary embolism
- Completed at least 3 months of therapeutic anticoagulation and currently receiving anticoagulation
- Enrollment within 12 months of diagnosis of the index/qualifying VTE event
- Able to provide written informed consent
- Able to participate in shared decision-making in English or French
Exclusion Criteria:
- Recurrent unprovoked or weakly provoked VTE I(i.e. multiple unprovoked/weakly provoked VTE)
- Index/qualifying VTE is a strongly provoked VTE (e.g., associated with major surgery, major trauma, plaster cast immobilization, or prolonged bed rest)
- Index/qualifying VTE associated with a persistent strong provoking risk factor (e.g., active cancer or ongoing immobility)
- Women at very low recurrence risk (HERDOO2 score 0-1)
- High bleeding risk such that anticoagulation should be discontinued
- Requirement for long-term anticoagulation for another indication (e.g., atrial fibrillation)
- Prior dedicated long-term anticoagulation Decision Visit regarding anticoagulation duration
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Usual Care
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.
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Experimental: DECIDE-VTE Patient Decision Aid
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.
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The DECIDE-VTE Patient Decision Aid is a bilingual (English/French) 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Decisional Conflict Scale (DCS) Total Score
Periodo de tiempo: Decision Visit (Day 0)
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Decisional conflict measured using the validated 16-item Decisional Conflict Scale (DCS).
Total scores range from 0 to 100, with higher scores indicating greater decisional conflict.
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Decision Visit (Day 0)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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VTE Knowledge Assessment Score
Periodo de tiempo: Decision Visit (Day 0)
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Patient knowledge regarding recurrent venous thromboembolism and bleeding risks assessed using a 6-item true/false questionnaire.
Scores range from 0 to 6, with higher scores indicating greater knowledge.
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Decision Visit (Day 0)
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Treatment Decision
Periodo de tiempo: Decision Visit (Day 0)
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Patient decision regarding continuation versus discontinuation of anticoagulation therapy.
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Decision Visit (Day 0)
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Decisional Regret Scale (DRS) Score
Periodo de tiempo: 3-Month Follow-Up Visit (Day 90 ± 14 days)
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Decisional regret measured using the validated 5-item Decisional Regret Scale (DRS).
Scores range from 0 to 100, with higher scores indicating greater regret regarding the treatment decision.
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3-Month Follow-Up Visit (Day 90 ± 14 days)
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Concordance With Treatment Decision
Periodo de tiempo: 3-Month Follow-Up Visit (Day 90 ± 14 days) and 12-Month Follow-Up Visit (Day 365 ± 60 days)
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Agreement between the treatment decision made at the Decision Visit (Day 0) and participant-reported anticoagulant use status at follow-up.
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3-Month Follow-Up Visit (Day 90 ± 14 days) and 12-Month Follow-Up Visit (Day 365 ± 60 days)
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Recurrent Venous Thromboembolism
Periodo de tiempo: 12-Month Follow-Up Visit (Day 365 ± 60 days)
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Adjudicated objectively confirmed recurrent venous thromboembolism assessed using the INVENT VERDICT adjudication process.
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12-Month Follow-Up Visit (Day 365 ± 60 days)
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Major Bleeding
Periodo de tiempo: 12-Month Follow-Up Visit (Day 365 ± 60 days)
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Adjudicated objectively confirmed major bleeding defined according to International Society on Thrombosis and Haemostasis criteria.
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12-Month Follow-Up Visit (Day 365 ± 60 days)
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All-Cause Mortality
Periodo de tiempo: 12-Month Follow-Up Visit (Day 365 ± 60 days)
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Death from any cause identified through medical record review and, where necessary, provincial vital statistics records.
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12-Month Follow-Up Visit (Day 365 ± 60 days)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Decision Aid Use Time
Periodo de tiempo: Decision Visit (Day 0)
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Time in minutes spent interacting with the DECIDE-VTE Patient Decision Aid.
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Decision Visit (Day 0)
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Physician Visit Duration
Periodo de tiempo: Decision Visit (Day 0)
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Time in minutes from the participant entering the clinic room with the physician until completion of the clinical encounter.
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Decision Visit (Day 0)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marc Rodger, MD MSc FRCPC, McGill University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DECIDE-VTE-SWRCT
- 202509PJT-552796-CID-CFAC-5562 (Otro identificador: Canadian Institute of Health Research)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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