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

NCT06871514 | Recruiting

• 1 other identifier: 24U-1636
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 8

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.

Conditions

Atherosclerotic Cardiovascular Diseases; Shared-decision Making

Outcome Measures

Primary Outcomes (7)

• 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)

• Decisional conflict

  Assessed using the 16-item Decisional Conflict Scale (DCS), rated on a 5-point scale (0 = strongly agree, 4 = strongly disagree). Scores are transformed to a 0-100 scale, where higher scores indicate greater decisional conflict.

  At baseline (0 months from enrollment)

• Quality of life (as measured with PROMIS)

  Assessed using two shorts form of the Patient-Reported Outcomes Measurement Information System (PROMIS): Global Health Form and Physical Function. Scores are standardized T-scores (mean = 50, SD = 10), with higher scores indicating better physical function and overall health.

  At 12 months from enrollment

Secondary Outcomes (5)

• Consultation efficiency (healthcare providers' perceived acceptability, appropriateness, and feasibility of the intervention)

  Within 1 month of last inclusion of consulting healthcare provider

• Cost-effectiveness composite

  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.

• Prescription rates of cardiovascular disease preventive treatments

  At 12 months from enrollment

• Healthcare costs

  From baseline to the end of follow-up at 12 months. (the questionnaire is administered at 3, 6 and 12 months from enrollment)

• Quality of life (to inform cost-effectiveness analyses)

  At 12 months from enrollment

Study Arms (2)

Usual care

OTHER

Other: No Intervention: usual care

2-DECIDE intervention

EXPERIMENTAL

Other: 2-DECIDE intervention: decision support for cardiovascular risk management

Interventions

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.

2-DECIDE intervention

No Intervention: usual care OTHER

Usual care

Usual care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• dr.Frank L.J. Visseren: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (8)

Noordwest Ziekenhuisgroep

Alkmaar, 1815 JD, Netherlands

NOT YET RECRUITING

Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands

NOT YET RECRUITING

Deventer Ziekenhuis

Deventer, 7416 SE, Netherlands

RECRUITING

Ziekenhuis Gelderse Vallei

Ede, 6716 RP, Netherlands

NOT YET RECRUITING

Radboudumc

Nijmegen, 6525 GA, Netherlands

NOT YET RECRUITING

HagaZiekenhuis

The Hague, 2545 AA, Netherlands

NOT YET RECRUITING

Diakonessenhuis

Utrecht, 3582 KE, Netherlands

RECRUITING

UMC Utrecht

Utrecht, 3584 CX, Netherlands

NOT YET RECRUITING

Central Study Contacts

Elbrich Wempe, MD, PhD candidate

CONTACT

003188 75 555 55; 2-DECIDE@umcutrecht.nl

Steven Hageman, Assistant professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr. F.L.J. Visseren

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: March 12, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (8)