Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism (DECIDE-VTE)

June 19, 2026 updated by: Marc Rodger, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
850

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University Of Calgary
        • Contact:
        • Principal Investigator:
          • Leslie Skieth, MD FRCPC
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1N1
        • Vancouver General Hospital
        • Contact:
        • Principal Investigator:
          • Rick Ikesaka, MD MSc. FRCPC DRCPSC
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital - General Campus
        • Contact:
        • Principal Investigator:
          • Deborah Siegal, MD MSc FRCPC
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Sir Mortimer B. Davis Jewish General Hospital
        • Contact:
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Institute of McGill University Health Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
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.
Experimental: DECIDE-VTE Patient Decision Aid
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Decision Visit (Day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Decision Visit (Day 0)
Treatment Decision
Time Frame: Decision Visit (Day 0)
Patient decision regarding continuation versus discontinuation of anticoagulation therapy.
Decision Visit (Day 0)
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.
3-Month Follow-Up Visit (Day 90 ± 14 days)
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.
3-Month Follow-Up Visit (Day 90 ± 14 days) and 12-Month Follow-Up Visit (Day 365 ± 60 days)
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.
12-Month Follow-Up Visit (Day 365 ± 60 days)
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.
12-Month Follow-Up Visit (Day 365 ± 60 days)
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.
12-Month Follow-Up Visit (Day 365 ± 60 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Decision Aid Use Time
Time Frame: Decision Visit (Day 0)
Time in minutes spent interacting with the DECIDE-VTE Patient Decision Aid.
Decision Visit (Day 0)
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.
Decision Visit (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Rodger, MD MSc FRCPC, McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DECIDE-VTE-SWRCT
  • 202509PJT-552796-CID-CFAC-5562 (Other Identifier: Canadian Institute of Health Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

TBD near end of follow-up of last participant

IPD Sharing Access Criteria

contact study PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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