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

19. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

850

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Etterforskere

  • Hovedetterforsker: Marc Rodger, MD MSc FRCPC, McGill University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. mars 2028

Studiet fullført (Antatt)

1. mars 2029

Datoer for studieregistrering

Først innsendt

5. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-delingstidsramme

TBD near end of follow-up of last participant

Tilgangskriterier for IPD-deling

contact study PI

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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