Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism

NCT07659106 | Not Yet Recruiting

• 2 other identifiers: DECIDE-VTE-SWRCT202509PJT-552796-CID-CFAC-5562
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 5

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.

Conditions

Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Pulmonary Embolism

Keywords

Anticoagulation; Patient Decision Aid; Shared Decision Making; Extended Anticoagulation; Decisional Conflict; Stepped-Wedge Cluster Randomized Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Decision Visit (Day 0)

Secondary Outcomes (7)

• VTE Knowledge Assessment Score

  Decision Visit (Day 0)

• Treatment Decision

  Decision Visit (Day 0)

• Decisional Regret Scale (DRS) Score

  3-Month Follow-Up Visit (Day 90 ± 14 days)

• Concordance With Treatment Decision

  3-Month Follow-Up Visit (Day 90 ± 14 days) and 12-Month Follow-Up Visit (Day 365 ± 60 days)

• Recurrent Venous Thromboembolism

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

Other Outcomes (2)

• Patient Decision Aid Use Time

  Decision Visit (Day 0)

• Physician Visit Duration

  Decision Visit (Day 0)

Study Arms (2)

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.

Behavioral: DECIDE-VTE Patient Decision Aid

Interventions

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.

DECIDE-VTE Patient Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (5)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1N1, Canada

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Research Institute of McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Marc Rodger, MD MSc FRCPC

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harika Dasari

CONTACT

5144319353; harika.dasari@rimuhc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: TBD near end of follow-up of last participant
• Access Criteria: contact study PI

Locations

CA (5)