Improving decision-making support for patients with cardiovascular disease
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
This study is testing a new way to help patients with heart disease understand their treatment choices better by encouraging more discussion with their doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 8 sites (Alkmaar and 7 other locations) |
| Trial ID | NCT06871514 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the way patients with cardiovascular diseases understand their treatment options by implementing a decision support intervention. It focuses on facilitating shared decision-making between patients and healthcare providers, where doctors will spend additional time discussing treatment alternatives. Patients will complete questionnaires after their clinic visits to evaluate the effectiveness of this approach compared to usual care. The study targets individuals with established atherosclerotic cardiovascular disease (ASCVD) to assess the impact of improved communication on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with established atherosclerotic cardiovascular disease who have had a recent cardiovascular event or imaging confirming their condition.
Not a fit: Patients without established ASCVD or those who have not experienced a recent cardiovascular event may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better-informed patients and improved management of cardiovascular disease.
How similar studies have performed: Other studies have shown that enhanced decision support can improve patient outcomes in cardiovascular care, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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. Exclusion criteria: * 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
Where this trial is running
Alkmaar and 7 other locations
- Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (Not_yet_recruiting)
- Meander Medisch Centrum — Amersfoort, Netherlands (Not_yet_recruiting)
- Deventer Ziekenhuis — Deventer, Netherlands (Recruiting)
- Ziekenhuis Gelderse Vallei — Ede, Netherlands (Not_yet_recruiting)
- Radboudumc — Nijmegen, Netherlands (Not_yet_recruiting)
- HagaZiekenhuis — The Hague, Netherlands (Not_yet_recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Recruiting)
- UMC Utrecht — Utrecht, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Elbrich Wempe, MD, PhD candidate
- Email: 2-DECIDE@umcutrecht.nl
- Phone: 003188 75 555 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.