Clinical trial NCT06871514: Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atherosclerotic Cardiovascular Diseases
Shared-decision Making
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2025-03-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Clinical Trial: All centers will start with care as usual. At randomized intervals, they will switch to application of the 2-DECIDE intervention.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 10-year residual cardiovascular disease risk
timeFrame: At 12 months from enrollment
measure: Adherence to medication
timeFrame: At 12 months from enrollment
measure: Beliefs underlying adherence
timeFrame: Baseline and at 12 months from enrollment
measure: Knowledge and motivation in patient
timeFrame: Baseline and at 12 months from enrollment
measure: Experienced shared-decision making
timeFrame: At baseline (0 months from enrollment)
measure: Decisional conflict
timeFrame: At baseline (0 months from enrollment)
measure: Quality of life (as measured with PROMIS)
timeFrame: At 12 months from enrollment
Secondary outcomes:
measure: Consultation efficiency (healthcare providers' perceived acceptability, appropriateness, and feasibility of the intervention)
timeFrame: Within 1 month of last inclusion of consulting healthcare provider
measure: Cost-effectiveness composite
timeFrame: 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.
measure: Prescription rates of cardiovascular disease preventive treatments
timeFrame: At 12 months from enrollment
measure: Healthcare costs
timeFrame: From baseline to the end of follow-up at 12 months. (the questionnaire is administered at 3, 6 and 12 months from enrollment)
measure: Quality of life (to inform cost-effectiveness analyses)
timeFrame: At 12 months from enrollment
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References: