Venous Thromboembolism (VTE)DECIDE-VTENCT07659106
Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism
A study testing DECIDE-VTE Patient Decision Aid in people with Venous Thromboembolism (VTE) and Deep Vein Thrombosis (DVT), run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 5 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism
- What is being tested?
- DECIDE-VTE Patient Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 5 sitesCanada
- Study dates
- Sep 2026to Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites
University of Calgary
Calgary, Alberta, T2N 1N4
Jill Baxter, 403-944-5246, jbaxter@ucalgary.ca
Leslie Skieth, MD FRCPC
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Elena Shulikovsky, 514-340-8222 ext. 23703, eshulikovsky@jgh.mcgill.ca
Research Institute of McGill University Health Centre
Montreal, Quebec, H4A 3J1
Sidra Ahmed, 514-934-1934, Sidra.Ahmed@rimuhc.ca
Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Amanda Pecarskie, 6137378899 ext. 78804, apecarskie@ohri.ca
Deborah Siegal, MD MSc FRCPC
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1N1
Edward Wong, 604-875-4111 ext. 22966, edward.wong@bccancer.bc.ca
Rick Ikesaka, MD MSc. FRCPC DRCPSC
About this study
Official title: 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.
Read the 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.
- Being tested
- DECIDE-VTE Patient Decision Aid
- Keywords
- Anticoagulation, Patient Decision Aid, Shared Decision Making, Extended Anticoagulation, Decisional Conflict, Stepped-Wedge Cluster Randomized Trial
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECIDE-VTE Patient Decision AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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. |
| DECIDE-VTE Patient Decision Aid | Experimental | 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. Receives: Behavioral: DECIDE-VTE Patient Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Decision Visit (Day 0)
Secondary outcomes (7)
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.
Measured: Decision Visit (Day 0)
Treatment Decision
Patient decision regarding continuation versus discontinuation of anticoagulation therapy.
Measured: Decision Visit (Day 0)
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.
Measured: 3-Month Follow-Up Visit (Day 90 ± 14 days)
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.
Measured: 3-Month Follow-Up Visit (Day 90 ± 14 days) and 12-Month Follow-Up Visit (Day 365 ± 60 days)
Recurrent Venous Thromboembolism
Adjudicated objectively confirmed recurrent venous thromboembolism assessed using the INVENT VERDICT adjudication process.
Measured: 12-Month Follow-Up Visit (Day 365 ± 60 days)
Major Bleeding
Adjudicated objectively confirmed major bleeding defined according to International Society on Thrombosis and Haemostasis criteria.
Measured: 12-Month Follow-Up Visit (Day 365 ± 60 days)
All-Cause Mortality
Death from any cause identified through medical record review and, where necessary, provincial vital statistics records.
Measured: 12-Month Follow-Up Visit (Day 365 ± 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Rodger, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Marc Rodger, MD MSc FRCPC, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659106
- Sponsor's protocol ID
- DECIDE-VTE-SWRCT
- Other IDs
- 202509PJT-552796-CID-CFAC-5562
- Acronym
- DECIDE-VTE
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes