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NCT Number: NCT07659106

Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism

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.

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Key information

Conditions

Venous Thromboembolism (VTE) Cardiovascular Diseases Deep Vein Thrombosis (DVT) Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DECIDE-VTE Patient Decision Aid

Behavioral

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.

Primary outcomes

  1. Decisional Conflict Scale (DCS) Total Score

    Time frame: 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 outcomes

  1. VTE Knowledge Assessment Score

    Time frame: 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.

  2. Treatment Decision

    Time frame: Decision Visit (Day 0)

    Patient decision regarding continuation versus discontinuation of anticoagulation therapy.

  3. Decisional Regret Scale (DRS) Score

    Time frame: 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.

  4. 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)

    Agreement between the treatment decision made at the Decision Visit (Day 0) and participant-reported anticoagulant use status at follow-up.

  5. Recurrent Venous Thromboembolism

    Time frame: 12-Month Follow-Up Visit (Day 365 ± 60 days)

    Adjudicated objectively confirmed recurrent venous thromboembolism assessed using the INVENT VERDICT adjudication process.

  6. Major Bleeding

    Time frame: 12-Month Follow-Up Visit (Day 365 ± 60 days)

    Adjudicated objectively confirmed major bleeding defined according to International Society on Thrombosis and Haemostasis criteria.

  7. All-Cause Mortality

    Time frame: 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.

Other outcomes

  1. Patient Decision Aid Use Time

    Time frame: Decision Visit (Day 0)

    Time in minutes spent interacting with the DECIDE-VTE Patient Decision Aid.

  2. Physician Visit Duration

    Time frame: Decision Visit (Day 0)

    Time in minutes from the participant entering the clinic room with the physician until completion of the clinical encounter.

Study contacts

Contact information is provided by the study sponsor or research team.

Harika Dasari

CONTACT

[email protected]

5144319353

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

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

Acronym: DECIDE-VTE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 22, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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