Improving cardiovascular population risk in primary care: protocol for the PROSPERA cluster-randomised controlled trial of a complex multilevel intervention
4 affiliations
- 1Public Health and Primary Care, Leiden University Medical Center, Leiden, Netherlands
- 2Vascular Medicine and Endocrinology, University Medical Centre Utrecht, Utrecht, Netherlands
- 3Erasmus School of Health Policy and Management, Erasmus University Rotterdam, Rotterdam, Netherlands
- 4Psychiatry, University Medical Centre Utrecht, Utrecht, Netherlands
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. 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 programme, a population-level risk-based approach aimed at improving cardiovascular risk management in primary care.
Methods and analysis: The PROSPERA study is a pragmatic 1:1 cluster randomised controlled trial in 22 primary care practices in the greater Leiden and The Hague region in the Netherlands, investigating real-world effectiveness of usual care plus the PROSPERA programme with usual care alone. The PROSPERA programme consists of (1) a population-level risk stratification overview to anticipate care needs (empanelment), (2) training for healthcare professionals in cardiovascular risk communication, (3) a lifestyle questionnaire completed by patients before consultation (Lifestylecheck) and (4) a clinical decision support tool (U-Prevent). The programme aims to support a more targeted use of available resources by identifying patients at higher risk and tailoring preventive efforts to those who may benefit most, thereby potentially improving the efficiency and effectiveness of care. Patients between 40 and 90 years of age enrolled in integrated care programmes (programmes developed to ensure a continuum of care for patients with chronic conditions) for increased cardiovascular risk are included. The primary outcome is defined as the proportion of the participants with successful achievement of all protocol-defined cardiovascular preventive treatment goals at 18 months of follow-up. Secondary outcomes include implementation outcomes (penetration and fidelity), healthcare professionals’ satisfaction on usability of the PROSPERA programme, patient experience with shared decision-making and decisional conflict when making a healthcare decision and outcomes on cost-effectiveness.
Ethics and dissemination: Consent for the use of routine healthcare data are 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.
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BibTeX
@article{bongaerts2026improving,
title = {{Improving cardiovascular population risk in primary care: protocol for the PROSPERA cluster-randomised controlled trial of a complex multilevel intervention}},
author = {Vera A M C Bongaerts and Rimke C Vos and Steven H J Hageman and Ken Redekop and Jannick A N Dorresteijn and Mattijs E Numans and Hendrikus J A Van Os},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-118002},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-118002},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Improving cardiovascular population risk in primary care: protocol for the PROSPERA cluster-randomised controlled trial of a complex multilevel intervention
AU - Vera A M C Bongaerts
AU - Rimke C Vos
AU - Steven H J Hageman
AU - Ken Redekop
AU - Jannick A N Dorresteijn
AU - Mattijs E Numans
AU - Hendrikus J A Van Os
PY - 2026
DA - 2026/10/27
JO - BMJ Open
DO - 10.1136/bmjopen-2026-118002
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-118002
AB - 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. 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 programme, a population-level risk-based approach aimed at improving cardiovascular risk management in primary care. Methods and analysis: The PROSPERA study is a pragmatic 1:1 cluster randomised controlled trial in 22 primary care practices in the greater Leiden and The Hague region in the Netherlands, investigating real-world effectiveness of usual care plus the PROSPERA programme with usual care alone. The PROSPERA programme consists of (1) a population-level risk stratification overview to anticipate care needs (empanelment), (2) training for healthcare professionals in cardiovascular risk communication, (3) a lifestyle questionnaire completed by patients before consultation (Lifestylecheck) and (4) a clinical decision support tool (U-Prevent). The programme aims to support a more targeted use of available resources by identifying patients at higher risk and tailoring preventive efforts to those who may benefit most, thereby potentially improving the efficiency and effectiveness of care. Patients between 40 and 90 years of age enrolled in integrated care programmes (programmes developed to ensure a continuum of care for patients with chronic conditions) for increased cardiovascular risk are included. The primary outcome is defined as the proportion of the participants with successful achievement of all protocol-defined cardiovascular preventive treatment goals at 18 months of follow-up. Secondary outcomes include implementation outcomes (penetration and fidelity), healthcare professionals’ satisfaction on usability of the PROSPERA programme, patient experience with shared decision-making and decisional conflict when making a healthcare decision and outcomes on cost-effectiveness. Ethics and dissemination: Consent for the use of routine healthcare data are 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.
SN - 2044-6055
SN - 2044-6055
ER -