Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
Sponsordr.Frank L.J. Visseren
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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)
Systolic Blood Pressure (SBP) <90 mmHg or >200 mmHg
Total cholesterol <2.5mmol/L or >8 mmol/L
Trial design
Design model
Sequential
Treatments tested in this trial
2-DECIDE intervention: decision support for cardiovascular risk management
Other interventionThe 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.
No Intervention: usual care
Other interventionUsual care
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Usual careOther 1 intervention
Group B: 2-DECIDE interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
10-year residual cardiovascular disease risk
Calculated using the SMART2 risk model
Time frame
At 12 months from enrollment2
Adherence to medication
Assessed using data on medication dispensing data via Stichting Farmacotherapeutische Kengetallen (SFK) linkage, which connects individual pharmacy records across the Netherlands
Time frame
At 12 months from enrollment3
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.
Time frame
Baseline and at 12 months from enrollment4
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.
Time frame
Baseline and at 12 months from enrollmentSecondary outcomes
1
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.
Time frame
Within 1 month of last inclusion of consulting healthcare provider2
Cost-effectiveness composite
Modelled long-term cost and benefit outcomes. In line with the Dutch recommendations for performing cost-effectiveness analyses, a lifetime horizon will be used (a modelled approach, based on extrapolation of short-term observed costs). This modelling will be performed using study-specific data, supplemented with Dutch data on event and care costs across this population for a more stable estimate (UCC-SMART cohort linked to VEKTIS cost data)
Time frame
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.3
Prescription rates of cardiovascular disease preventive treatments
Time frame
At 12 months from enrollment4
Healthcare costs
Medication and healthcare consumption, using an adjusted version of the iMTA Medical Consumption Questionnaire (iMCQ) and iPCQ (Productivity Cost Questionnaire)
Time frame
From baseline to the end of follow-up at 12 months. (the questionnaire is administered at 3, 6 and 12 months from enrollment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
dr.Frank L.J. Visseren
Lead sponsor
UMC Utrecht
Sponsor institution
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov