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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
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.
Usual care
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
NOT_YET_RECRUITINGMeander Medisch Centrum
Amersfoort, Netherlands
NOT_YET_RECRUITINGDeventer Ziekenhuis
Deventer, Netherlands
RECRUITINGZiekenhuis Gelderse Vallei
Ede, Netherlands
NOT_YET_RECRUITINGRadboudumc
Nijmegen, Netherlands
NOT_YET_RECRUITINGHagaZiekenhuis
The Hague, Netherlands
NOT_YET_RECRUITINGDiakonessenhuis
Utrecht, Netherlands
RECRUITINGUMC Utrecht
Utrecht, Netherlands
NOT_YET_RECRUITING10-year residual cardiovascular disease risk
Calculated using the SMART2 risk model
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At 12 months from enrollment
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 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)
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
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)
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.
Steven Hageman, Assistant professor
CONTACT
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Time frame: At 12 months from enrollment