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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 8
- 主要终点
- 10-year residual cardiovascular disease risk
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Usual care
干预措施: No Intervention: usual care (Other)
2-DECIDE intervention
干预措施: 2-DECIDE intervention: decision support for cardiovascular risk management (Other)
结局指标
主要结局
10-year residual cardiovascular disease risk
时间窗: At 12 months from enrollment
Calculated using the SMART2 risk model
Adherence to medication
时间窗: At 12 months from enrollment
Assessed using data on medication dispensing data via Stichting Farmacotherapeutische Kengetallen (SFK) linkage, which connects individual pharmacy records across the Netherlands
Beliefs underlying adherence
时间窗: Baseline and at 12 months from enrollment
Assessed using the Beliefs about Medicines Questionnaire (BMQ), consisting of BMQ-General (8 items) and BMQ-Specific (11 items). Items are rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Subscale scores are summed, and difference scores between subscales are calculated. In BMQ-Specific, a positive score indicates perceived benefits outweigh concerns about medicination. In BMQ-General, a positive score indicates trust in medication and prescribing outweighs negative perceptions of medicines in general.
Knowledge and motivation in patient
时间窗: Baseline and at 12 months from enrollment
Assessed using the Patient Activation Measure ® (PAM-13 ®), an empirical interval scale from 0 to 100, corresponding to four patient activation levels. Levels 1-2 indicate lower activation, while Levels 3-4 indicate higher activation.
Experienced shared-decision making
时间窗: At baseline (0 months from enrollment)
Assessed using the 9-item Shared Decision Making Questionnaire (SDM-Q9), rated on a 6-point scale (0 = completely disagree, 5 = completely agree). The total raw score (0-45) is transformed to a 0-100 scale, with higher scores indicating greater experienced shared decision-making by the patient
Decisional conflict
时间窗: At baseline (0 months from enrollment)
Assessed using the 16-item Decisional Conflict Scale (DCS), rated on a 5-point scale (0 = strongly agree, 4 = strongly disagree). Scores are transformed to a 0-100 scale, where higher scores indicate greater decisional conflict.
Quality of life (as measured with PROMIS)
时间窗: At 12 months from enrollment
Assessed using two shorts form of the Patient-Reported Outcomes Measurement Information System (PROMIS): Global Health Form and Physical Function. Scores are standardized T-scores (mean = 50, SD = 10), with higher scores indicating better physical function and overall health.
次要结局
- Consultation efficiency (healthcare providers' perceived acceptability, appropriateness, and feasibility of the intervention)(Within 1 month of last inclusion of consulting healthcare provider)
- Cost-effectiveness composite(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(At 12 months from enrollment)
- Healthcare costs(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)(At 12 months from enrollment)
研究者
dr.Frank L.J. Visseren
Prof. dr. F.L.J. Visseren
UMC Utrecht