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

19. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

850

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decisional Conflict Scale (DCS) Total Score
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
VTE Knowledge Assessment Score
Tidsramme: 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
Tidsramme: Decision Visit (Day 0)
Patient decision regarding continuation versus discontinuation of anticoagulation therapy.
Decision Visit (Day 0)
Decisional Regret Scale (DRS) Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Decision Aid Use Time
Tidsramme: Decision Visit (Day 0)
Time in minutes spent interacting with the DECIDE-VTE Patient Decision Aid.
Decision Visit (Day 0)
Physician Visit Duration
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Efterforskere

  • Ledende efterforsker: Marc Rodger, MD MSc FRCPC, McGill University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2029

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DECIDE-VTE-SWRCT
  • 202509PJT-552796-CID-CFAC-5562 (Anden identifikator: Canadian Institute of Health Research)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

TBD near end of follow-up of last participant

IPD-delingsadgangskriterier

contact study PI

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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