Improving cardiovascular population risk in primary care: protocol for the PROSPERA cluster-randomized controlled trial of a complex multilevel intervention

ABSTRACT Introduction The growing burden of cardiovascular disease (CVD) threatens the sustainability of our healthcare systems. In the Netherlands, two-thirds of CVD-related healthcare is delivered in primary care practices, primarily by practice nurses. Given the increasing staffing shortages and the substantial heterogeneity of the population of primary care patients at increased risk of CVD, cardiovascular risk management strategies should be better tailored to individual patients’ needs and risk profiles. Therefore, we developed the PROSPERA program, aimed at the population of patients enrolled in integrated care programs for cardiovascular risk management in primary care. Methods and analysis The PROSPERA study is a pragmatic 1:1 cluster randomized controlled trial in 22 primary care practices in the greater Leiden and the Hague region in The Netherlands, investigating real-world effectiveness of the PROSPERA program with care as usual. The PROSPERA program is a multilevel complex intervention, including a population-level risk stratification and three individual patient-level components: a healthcare professional training program in cardiovascular risk communication, a lifestyle questionnaire (Lifestylecheck), and a clinical decision support tool (U-Prevent). Patients between 40–90 years of age enrolled in integrated care programs for increased cardiovascular risk are included. The primary outcome is defined as successful achievement of all protocol-defined cardiovascular preventive treatment goals, measured as the difference between the proportion of patients who meet the outcome in the intervention versus the control group at 18 months. Secondary outcomes include implementation outcomes, healthcare professionals’ satisfaction on usability of the PROSPERA program, patient experience with shared decision making and decisional conflict, and outcomes on cost-effectiveness. Ethics and dissemination Consent for the use of routine healthcare data is obtained through an opt-out procedure for participating practices. Digital informed consent will be obtained for the study questionnaires for patients and healthcare professionals. Main findings on effectivity, efficacy and implementation will be disseminated via peer-reviewed journals and via (inter)national conferences. Trial registration number NCT06593704 Strengths and limitations of this study The PROSPERA program was co-developed with stakeholders and refined via a preceding qualitative study, ensuring better integration with clinical workflows. The pragmatic design of this study allows for broad inclusion at the level of the population at increased risk of CVD, enhancing representativeness and inclusivity. Use of the Extramural Leiden Medical Center Academic Network (ELAN) data infrastructure enables comprehensive collection of healthcare data. The complexity of the current information- and technology (IT) infrastructure prototype is a constraint, but is expected to be simplified in the future. Potential cross-over contamination cannot be prevented, as control practices may have informal access to some PROSPERA components, although these are not yet widely implemented.