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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerotic Cardiovascular Diseases Shared-decision Making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

Group Type OTHER

No Intervention: usual care

Intervention Type OTHER

Usual care

2-DECIDE intervention

Group Type EXPERIMENTAL

2-DECIDE intervention: decision support for cardiovascular risk management

Intervention Type 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.

Interventions

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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 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.

Intervention Type OTHER

No Intervention: usual care

Usual care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No