Deep Vein Thrombosis (DVT), Pulmonary Embolism, Venous Thromboembolism (VTE)
Conditions
Keywords
Anticoagulation, Patient Decision Aid, Shared Decision Making, Extended Anticoagulation, Decisional Conflict, Stepped-Wedge Cluster Randomized Trial
Brief summary
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
BEHAVIORALDECIDE-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 incorporates a structured values clarification exercise to support shared decision-making between patients and clinicians during the anticoagulation Decision Visit.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a pragmatic multicentre batched stepped-wedge cluster randomized trial involving 12 thrombosis clinics across Canada. All clinics begin in the usual care phase and transition to implementation of the DECIDE-VTE patient decision aid according to a randomized crossover schedule. Randomization occurs at the clinic level, and clinics remain in the intervention phase after crossover for the remainder of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale (DCS) Total Score | Decision Visit (Day 0) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VTE Knowledge Assessment Score | Decision Visit (Day 0) | 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. |
| Treatment Decision | Decision Visit (Day 0) | Patient decision regarding continuation versus discontinuation of anticoagulation therapy. |
| Decisional Regret Scale (DRS) Score | 3-Month Follow-Up Visit (Day 90 ± 14 days) | 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. |
| Concordance With Treatment Decision | 3-Month Follow-Up Visit (Day 90 ± 14 days) and 12-Month Follow-Up Visit (Day 365 ± 60 days) | Agreement between the treatment decision made at the Decision Visit (Day 0) and participant-reported anticoagulant use status at follow-up. |
| Recurrent Venous Thromboembolism | 12-Month Follow-Up Visit (Day 365 ± 60 days) | Adjudicated objectively confirmed recurrent venous thromboembolism assessed using the INVENT VERDICT adjudication process. |
| Major Bleeding | 12-Month Follow-Up Visit (Day 365 ± 60 days) | Adjudicated objectively confirmed major bleeding defined according to International Society on Thrombosis and Haemostasis criteria. |
| All-Cause Mortality | 12-Month Follow-Up Visit (Day 365 ± 60 days) | Death from any cause identified through medical record review and, where necessary, provincial vital statistics records. |
Countries
Canada
Contacts
CONTACTHarika Dasari
PRINCIPAL_INVESTIGATORMarc Rodger, MD MSc FRCPC
McGill University
Outcome results
None listed