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| ID | Type | Description | Link |
|---|---|---|---|
| 202509PJT-552796-CID-CFAC-5562 | Other Identifier | Canadian Institute of Health Research |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Decision Visit (Day 0) |
| Treatment Decision |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Decision Aid Use Time | Time in minutes spent interacting with the DECIDE-VTE Patient Decision Aid. | Decision Visit (Day 0) |
| Physician Visit Duration | Time in minutes from the participant entering the clinic room with the physician until completion of the clinical encounter. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harika Dasari | Contact | 5144319353 | harika.dasari@rimuhc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Marc Rodger, MD MSc FRCPC | McGill University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
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TBD near end of follow-up of last participant
contact study PI
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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.
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Patient decision regarding continuation versus discontinuation of anticoagulation therapy. |
| 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. | 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. | 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. | 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. | 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. | 12-Month Follow-Up Visit (Day 365 ± 60 days) |
| Decision Visit (Day 0) |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1N1 | Canada |
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| Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
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| Sir Mortimer B. Davis Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
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| Research Institute of McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
|
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
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