Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism

Official title

Enabling and Engaging Patients to Decide Indefinite Versus Short-Term Anticoagulation for Venous Thromboembolism (DECIDE-VTE)

Overview

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.

Detailed description

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.

Interventions

• Behavioral DECIDE-VTE Patient Decision Aid
  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 incorpora

Primary outcome measures

• Decisional Conflict Scale (DCS) Total Score [Time frame: Decision Visit (Day 0)]

Secondary outcome measures (7)

• VTE Knowledge Assessment Score [Time frame: Decision Visit (Day 0)]
• Treatment Decision [Time frame: Decision Visit (Day 0)]
• Decisional Regret Scale (DRS) Score [Time frame: 3-Month Follow-Up Visit (Day 90 ± 14 days)]
• Concordance With Treatment Decision [Time frame: 3-Month Follow-Up Visit (Day 90 ± 14 days) and 12-Month Follow-Up Visit (Day 365 ± 60 days)]
• Recurrent Venous Thromboembolism [Time frame: 12-Month Follow-Up Visit (Day 365 ± 60 days)]
• Major Bleeding [Time frame: 12-Month Follow-Up Visit (Day 365 ± 60 days)]
• All-Cause Mortality [Time frame: 12-Month Follow-Up Visit (Day 365 ± 60 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Supportive care

Study locations

Canada · 5 centers

• University of Calgary — Calgary
• Vancouver General Hospital — Vancouver
• Ottawa Hospital - General Campus — Ottawa
• Sir Mortimer B. Davis Jewish General Hospital — Montreal
• Research Institute of McGill University Health Centre — Montreal

Identifiers

NCT: NCT07659106 · DECIDE-VTE-SWRCT · 202509PJT-552796-CID-CFAC-5562

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗