Effectiveness of Decision Support for Cardiovascular Risk... | NCT06871514

Status Module

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual care	Other		Other: No Intervention: usual care
2-DECIDE intervention	Experimental		Other: 2-DECIDE intervention: decision support for cardiovascular risk management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2-DECIDE intervention: decision support for cardiovascular risk management	Other	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 decisions made using the U-prevent medical device. Additionally, the general practitioner receives a letter detailing the outcome and rationale of the shared decision, along with the individual estimates that have informed the treatment choice.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
10-year residual cardiovascular disease risk	Calculated using the SMART2 risk model	At 12 months from enrollment
Adherence to medication	Assessed using data on medication dispensing data via Stichting Farmacotherapeutische Kengetallen (SFK) linkage, which connects individual pharmacy records across the Netherlands	At 12 months from enrollment
Beliefs underlying adherence	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.	Baseline and at 12 months from enrollment
Knowledge and motivation in patient	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.	Baseline and at 12 months from enrollment
Experienced shared-decision making	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	At baseline (0 months from enrollment)

Secondary Outcomes

Measure	Description	Time Frame
Consultation efficiency (healthcare providers' perceived acceptability, appropriateness, and feasibility of the intervention)	Measured using the Acceptability of Intervention Measure, Intervention Appropriateness Measure, & Feasibility of Intervention Measure. Each measure consists of four items rated on a 5-point Likert scale (1 = Completely disagree, 5 = Completely agree). Scores are averaged (range: 1-5), with higher scores indicating greater acceptability, appropriateness, and feasibility. These measures will be completed once by the consulting healthcare providers at the end of the inclusion period of the intervention phase.

Eligibility Module

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

Name	Role	Phone	Extension	Email
Elbrich Wempe, MD, PhD candidate	Contact	003188 75 555 55		2-DECIDE@umcutrecht.nl
Steven Hageman, Assistant professor	Contact

Facility	Status	City	State	ZIP	Country	Contacts
Noordwest Ziekenhuisgroep	Not yet recruiting	Alkmaar		1815 JD	Netherlands
Meander Medisch Centrum