Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease (2-DECIDE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shared-decision Making; Atherosclerotic Cardiovascular Diseases
• Intervention / Treatment: Other: No Intervention: usual care; Other: 2-DECIDE intervention: decision support for cardiovascular risk management

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elbrich Wempe, MD, PhD candidate; Phone Number: 003188 75 555 55; Email: 2-DECIDE@umcutrecht.nl
• Study Contact Backup: Name: Steven Hageman, Assistant professor

Study Locations

• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Not yet recruiting
    • Noordwest Ziekenhuisgroep
  • Amersfoort, Netherlands, 3813 TZ
    • Not yet recruiting
    • Meander Medisch Centrum
  • Den Haag, Netherlands, 2545 AA
    • Not yet recruiting
    • HagaZiekenhuis
  • Deventer, Netherlands, 7416 SE
    • Recruiting
    • Deventer Ziekenhuis
  • Ede, Netherlands, 6716 RP
    • Not yet recruiting
    • Ziekenhuis Gelderse Vallei
  • Nijmegen, Netherlands, 6525 GA
    • Not yet recruiting
    • Radboudumc
  • Utrecht, Netherlands, 3582 KE
    • Recruiting
    • Diakonessenhuis
  • Utrecht, Netherlands, 3584 CX
    • Not yet recruiting
    • UMC Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care	Other: No Intervention: usual care; Usual care
Experimental: 2-DECIDE intervention	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)
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 Outcome Measures

Outcome Measure	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.	Within 1 month of last inclusion of consulting healthcare provider
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)	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	Medication and healthcare consumption, using an adjusted version of the iMTA Medical Consumption Questionnaire (iMCQ) and iPCQ (Productivity Cost Questionnaire)	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)	Assessed using EuroQol (EQ-5D-5L), to inform cost-effectiveness analyses. The EQ-5D-5L measures health across five dimensions, each with five levels of perceived problems. A summary index is calculated by applying weights to each level and deducting them from 1 (full health), with higher scores indicating better health. Index values support economic evaluations of healthcare interventions.	At 12 months from enrollment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: 24U-1636

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No