Atherosclerotic Cardiovascular Diseases2-DECIDENCT06871514
Effectiveness of Decision Support for Cardiovascular Risk Management in People With Cardiovascular Disease
A study testing 2-DECIDE intervention: decision support for cardiovascular risk management in people with Atherosclerotic Cardiovascular Diseases and Shared-decision Making, run by dr.Frank L.J. Visseren at 8 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Diseases, Shared-decision Making
- What is being tested?
- 2-DECIDE intervention: decision support for cardiovascular risk management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 8 sitesNetherlands
- Study dates
- 18 Feb 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Steven Hageman, Assistant professor contact
8 sites in 1 country
Netherlands8 sites, 8 recruiting
- Not yet recruiting
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD
- Not yet recruiting
Meander Medisch Centrum
Amersfoort, 3813 TZ
- Recruiting
Deventer Ziekenhuis
Deventer, 7416 SE
- Not yet recruiting
Ziekenhuis Gelderse Vallei
Ede, 6716 RP
- Not yet recruiting
Radboudumc
Nijmegen, 6525 GA
- Not yet recruiting
HagaZiekenhuis
The Hague, 2545 AA
- Recruiting
Diakonessenhuis
Utrecht, 3582 KE
- Not yet recruiting
UMC Utrecht
Utrecht, 3584 CX
About this study
Official title: 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.
- Being tested
- 2-DECIDE intervention: decision support for cardiovascular risk management, No Intervention: usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-DECIDE intervention: decision support for cardiovascular risk managementOther
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.
No Intervention: usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | Not described Receives: Other: No Intervention: usual care |
| 2-DECIDE intervention | Experimental | Not described Receives: Other: 2-DECIDE intervention: decision support for cardiovascular risk management |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-year residual cardiovascular disease risk
Calculated using the SMART2 risk model
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At 12 months from enrollment
Secondary outcomes (5)
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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: At 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start18 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dr.Frank L.J. Visseren
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor-investigator, dr.Frank L.J. Visseren, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871514
- Sponsor's protocol ID
- 24U-1636
- Acronym
- 2-DECIDE
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06871514
- Acronym / sponsor ID
- 2-DECIDE / 24U-1636
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- dr.Frank L.J. VisserenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Other: No Intervention: usual care |
| 2-DECIDE intervention | Experimental | Other: 2-DECIDE intervention: decision support for cardiovascular risk management |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Established ASCVD
- 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
Key exclusion criteria (10 listed)
- 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:
- Previous participation in 2-DECIDE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-DECIDE intervention: decision support for cardiovascular risk managementThe 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. | Other | 2-DECIDE intervention |
| No Intervention: usual careUsual care | Other | Usual care |
Primary outcome
10-year residual cardiovascular disease risk
Time frame: At 12 months from enrollment
Calculated using the SMART2 risk model
Adherence to medication
Time frame: At 12 months from enrollment
Assessed using data on medication dispensing data via Stichting Farmacotherapeutische Kengetallen (SFK) linkage, which connects individual pharmacy records across the Netherlands
Beliefs underlying adherence
Time frame: Baseline and at 12 months from enrollment
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.
Knowledge and motivation in patient
Time frame: Baseline and at 12 months from enrollment
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.
Experienced shared-decision making
Time frame: At baseline (0 months from enrollment)
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
Decisional conflict
Time frame: At baseline (0 months from enrollment)
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.
Quality of life (as measured with PROMIS)
Time frame: At 12 months from enrollment
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.
5 secondary outcomes
Consultation efficiency (healthcare providers' perceived acceptability, appropriateness, and feasibility of the intervention)
Time frame: Within 1 month of last inclusion of consulting healthcare provider
Cost-effectiveness composite
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.
Prescription rates of cardiovascular disease preventive treatments
Time frame: At 12 months from enrollment
Healthcare costs
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)
Quality of life (to inform cost-effectiveness analyses)
Time frame: At 12 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Hageman, Assistant professor contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-DECIDE intervention: decision support for cardiovascular risk management in people with Atherosclerotic Cardiovascular Diseases and Shared-decision Making, run by dr.Frank L.J. Visseren at 8 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elbrich Wempe, MD, PhD candidate (003188 75 555 55, 2-DECIDE@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-year residual cardiovascular disease risk (time frame: At 12 months from enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.