Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease

Официальное название

2-DECIDE: A Stepped-Wedge Multicenter Study on the Effectiveness of a Multicomponent Intervention With Shared Decision-Making to Improve Cardiovascular Risk Management in Adults With Established Atherosclerotic Cardiovascular Disease

Обзор

This study aims to improve the way patients with cardiovascular diseases are informed about their treatment options. It explores methods to support shared decision-making between patients and doctors. In some cases, doctors will take extra time to discuss treatment options in detail. To assess the impact, some patients will be asked to complete questionnaires after their clinic visits.

Вмешательства

• Другое 2-DECIDE intervention: decision support for cardiovascular risk management
  The 2-DECIDE intervention consists of: * Training of healthcare providers in implementing shared decision-making during clinical consultations. * At least one initial extended outpatient consultation with a trained physician to ensure adequate time for actual understanding of treatment options. * Decision support based on U-prevent * Clear communication to the patient is provided in an easily comprehensible format, including pre-visit information, and a post-visit handout of the information and
• Другое No Intervention: usual care
  Usual care

Первичные конечные точки

• 10-year residual cardiovascular disease risk [Срок оценки: At 12 months from enrollment]
• Adherence to medication [Срок оценки: At 12 months from enrollment]
• Beliefs underlying adherence [Срок оценки: Baseline and at 12 months from enrollment]
• Knowledge and motivation in patient [Срок оценки: Baseline and at 12 months from enrollment]
• Experienced shared-decision making [Срок оценки: At baseline (0 months from enrollment)]
• Decisional conflict [Срок оценки: At baseline (0 months from enrollment)]
• Quality of life (as measured with PROMIS) [Срок оценки: At 12 months from enrollment]

Вторичные конечные точки (5)

• Consultation efficiency (healthcare providers' perceived acceptability, appropriateness, and feasibility of the intervention) [Срок оценки: Within 1 month of last inclusion of consulting healthcare provider]
• Cost-effectiveness composite [Срок оценки: Short-term costs observed through the iMCQ/iPCQ questionnaire (administered at 3, 6, and 12 months) will be used to model long-term costs and benefits, projected over a lifetime horizon.]
• Prescription rates of cardiovascular disease preventive treatments [Срок оценки: At 12 months from enrollment]
• Healthcare costs [Срок оценки: From baseline to the end of follow-up at 12 months. (the questionnaire is administered at 3, 6 and 12 months from enrollment)]
• Quality of life (to inform cost-effectiveness analyses) [Срок оценки: At 12 months from enrollment]

Критерии участия

Критерии включения

• Established ASCVD

• At least 30 days since last CVD event and/or the diagnosis of ASCVD. If no CVD events have occurred, imaging confirming ASCVD must have been conducted at least 30 days prior.
• Documented ASCVD (defined according to the 2021 European Society of Cardiology guideline), which includes ASCVD established clinically or demonstrated unequivocally by imaging:
• Clinically documented ASCVD includes previous myocardial infarction, acute coronary syndrome, coronary revascularization (Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery (CABG)), and other arterial revascularization procedures, ischemic stroke or transient ischemic attack, and peripheral artery disease (from Fontaine stage II). Angina pectoris (stable) without imaging evidence of atherosclerosis does not qualify as ASCVD.
• ASCVD unambiguously identified through imaging, includes significant stenosis (>50%) on coronary angiography, computed tomography angiography, or carotic ultrasound. It also includes aortic aneurysms measuring ≥3cm. Only Carotid Intima-Media Thickness measurements (cIMT), Coronary Artery Calcium scoring or abnormal ankle-brachial index scores without evidence of stenosis, do not qualify as ASCVD.
• Age 40-80 years (to allow for individual risk predictions with the SMART2 model
• Patient attending the Cardiology or Vascular Medicine outpatient clinic
• Sufficient understanding of the Dutch language (due to the questionnaires being administered in Dutch).
• Written informed consent must be provided. Although the proposed intervention is not subject to the WMO, informed consent is required for the collection and processing of data, including the distribution of questionnaires.

Критерии исключения

• Patients currently participating in other interventional medication studies, or studies that directly affect the therapy plan
• Remaining life expectancy of less than 2 years as assessed by a consulting healthcare professional (these patients have no indication for cardiovascular risk management)
• Patients for whom individual risk predictions with the SMART2 model are not feasible:

• Systolic Blood Pressure (SBP) <90 mmHg or >200 mmHg
• Total cholesterol <2.5mmol/L or >8 mmol/L
• High-Density Lipoprotein (HDL) cholesterol <0.6mmol/L or >2.5 mmol/L
• Low-Density Lipoprotein (LDL) <0.1 mmol/L or >7.4 mmol /L
• Estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.73m2 or dialysis
• Active treatment for malignity, pregnancy, history of organ transplantation, or liver failure
• Previous participation in 2-DECIDE

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 8 центров

• Noordwest Ziekenhuisgroep — Alkmaar
• Meander Medisch Centrum — Amersfoort
• Deventer Ziekenhuis — Deventer
• Ziekenhuis Gelderse Vallei — Ede
• Radboudumc — Nijmegen
• HagaZiekenhuis — The Hague
• Diakonessenhuis — Utrecht
• UMC Utrecht — Utrecht

Идентификаторы

NCT: NCT06871514 · 24U-1636

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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