The PROSPERA-program is a complex multilevel approach that includes training for healthcare providers, a risk assessment process, and decision support tools to help match patients with the appropriate treatment based on their care needs. The goal of this clinical trial is to determine if the PROSPERA-program can improve the cardiovascular risk profile in patients aged 40-90 years enrolled in primary care programs for increased cardiovascular risk, such as cardiovascular disease, increased vascular risk, or diabetes. The main question it aims to answer is: • Does the cardiovascular risk profile improve for patients using the PROSPERA-program? Researchers will compare the PROSPERA-program with standard cardiovascular care to see if the program enhances cardiovascular population health in primary care. Additionally, the study will assess how well the PROSPERA-program fits into the workflow of primary care providers and supports shared decision-making. Participants will: * Receive a consultation with their general practitioner or practice nurse according to the PROSPERA-program. * Have their routinely collected healthcare data used for evaluation. * Be asked to complete a questionnaire or participate in an interview (for a subset of patients).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
848
The PROSPERA-program consists of the following components: 1. Health care provider training and education about U-Prevent and cardiovascular risk communication. 2. Risk stratification: proactive selection of cardiovascular patients through the PROSPERA-empanelment procedure - for the population with increased cardiovascular risk, prior to consultation. 3. Decision support tools: use of the Lifestylecheck and the U-Prevent clinical decision support tool to guide motivated shared decision making towards appropriate care matched to the care complexity of the patient - for the individual patient, during consultation.
Department of Public Health and Primary Care
The Hague, South Holland, Netherlands
The proportion of individuals who have achieved all protocol-defined cardiovascular prevention goals.
Protocol-defined treatment goals are in line with local prevention targets (including treatment targets such as Systolic Blood Pressure, LDL-cholesterol, Antithrombotic therapy, HbA1c, SGTL2 inhibitors and/or GLP1-receptor agonists). The sample size is based on the minimum number of subjects (patients) who will complete the component of the intervention conducted during consultation (= the clinical decision tools). A subset will receive additional questionnaires. The primary outcome will be compared among the complete study population as well as in the subgroup.
Time frame: At 0 and 18 months
Perceived shared decision making (in subset only)
9-item Shared Decision Making Questionnaire (SDM-Q-9)
Time frame: immediately after the intervention
Perceived shared decision making (in subset only)
Patient interviews (qualitative)
Time frame: immediately after the intervention
Decisional Conflict (in subset only)
The Decisional Conflict Scale (DCS)
Time frame: immediately after the intervention
Implementation outcome: fidelity
Percentage of target population that has received the U-Prevent component of the PROSPERA-program during the study duration as measured by the U-Prevent logbook.
Time frame: At month 4 and 10
Implementation outcome: fidelity
Fidelity checklist by HCPs .
Time frame: At month 4 and 10
Implementation outcome: penetration
The number of health care professionals who deliver the PROSPERA-program on an individual patient level (component 2) divided by the number of health care professionals who are expected to deliver this service.
Time frame: At month 10
Healthcare professional's satisfaction on usability of the PROSPERA-program
System Usability Scale
Time frame: At month 10
Cost-effectiveness
Cost-effectiveness of the PROSPERA-program in Quality-Adjusted Life Years (QALYs) as calculated in a cost-effectiveness analysis
Time frame: immediately after the intervention and at month 18
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