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.
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
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)
Crossover
DECIDE-VTE Patient Decision Aid
BehavioralThe 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.
Decisional Conflict Scale (DCS) Total Score
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.
VTE Knowledge Assessment Score
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
Patient decision regarding continuation versus discontinuation of anticoagulation therapy.
Decisional Regret Scale (DRS) Score
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
Agreement between the treatment decision made at the Decision Visit (Day 0) and participant-reported anticoagulant use status at follow-up.
Patient Decision Aid Use Time
Time in minutes spent interacting with the DECIDE-VTE Patient Decision Aid.
Physician Visit Duration
Time in minutes from the participant entering the clinic room with the physician until completion of the clinical encounter.
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