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

The PROSPERA study is a pragmatic cluster-randomized controlled trial in the Netherlands designed to evaluate the real-world effectiveness of a multilevel intervention—comprising risk stratification, professional training, a lifestyle questionnaire, and a clinical decision support tool—in improving cardiovascular risk management outcomes among primary care patients compared to usual care.

The Gist

Imagine your healthcare system as a massive, bustling city. Right now, this city is facing a traffic jam of a different kind: heart disease. It's clogging up the roads, threatening to overwhelm the emergency services, and costing a fortune to keep running.

In the Netherlands, most of the work to keep this city's heart healthy happens in the local neighborhoods, managed by Practice Nurses (the local traffic controllers). But these nurses are stretched thin, and every driver (patient) is different. Some need a gentle nudge, others need a full map, and some are driving a completely different type of vehicle. Trying to give everyone the exact same instructions isn't working well enough.

Enter PROSPERA, a new "traffic management system" designed to fix this.

The Big Idea: A Tailored GPS for Heart Health

Think of the PROSPERA program as a smart, multi-layered GPS for heart health, rather than just a generic map. It's being tested in 22 neighborhoods (primary care practices) to see if it works better than the old, standard way of driving.

Here is how this "smart GPS" works in three layers:

1. The Radar (Population Risk Stratification): Before you even get in the car, the system scans the whole neighborhood to identify who is most likely to get into a traffic accident (heart attack). It doesn't guess; it uses data to spot the risky drivers early.
2. The Driver's Training (Professional Training): The nurses (traffic controllers) get a special workshop. They learn how to talk to drivers about their risks without scaring them, turning a scary medical lecture into a helpful conversation.
3. The In-Car Tech (The Tools):
   • The Lifestyle Check: A simple questionnaire that acts like a car diagnostic tool, asking about diet, exercise, and habits.
   • The Decision Support Tool (U-Prevent): Think of this as a co-pilot. When the nurse is making a plan, this digital tool pops up with the best route based on the driver's specific data, ensuring they don't miss any turns toward a healthier heart.

The Experiment: A Race Between Two Groups

The researchers are running a pragmatic race (a real-world test) involving 22 neighborhoods.

• Group A gets the new PROSPERA "Smart GPS" system.
• Group B keeps driving with the "Old Map" (standard care).

They will watch these groups for 18 months. The main goal? To see which group has more drivers successfully reaching their destination: hitting all their heart-health targets (like blood pressure and cholesterol levels).

What Else Are They Measuring?

It's not just about the destination; it's about the journey. The researchers are also checking:

• The Driver's Experience: Did the patients feel heard? Did they feel confused, or did they feel like partners in the decision?
• The Traffic Controller's Satisfaction: Did the nurses find the new tools helpful, or were they just more paperwork?
• The Cost: Is this new system worth the fuel money, or does it actually save the city money in the long run?

The Rules of the Road (Ethics & Limitations)

• Permission: To use the data, the city asks for permission automatically (opt-out), but if you want to fill out extra surveys, you sign a digital form.
• The "Leak" Risk: Since the new system is so cool, there's a chance the "Old Map" drivers might peek at the new tools. The researchers know this might happen and are accounting for it.
• The Glitch: The current computer system is a bit like a prototype car with too many wires. It's complex right now, but the team promises to streamline it later.

Why This Matters

This study is special because it wasn't built in a lab by scientists alone; it was co-designed with the people actually using it (nurses and patients). It's designed to be inclusive, catching everyone from age 40 to 90, regardless of how complex their health history is.

If this "Smart GPS" works, it could mean a smoother, safer, and more efficient journey to a healthier heart for everyone, easing the burden on our healthcare city.

Technical Summary

Based on the provided abstract and study protocol, here is a detailed technical summary of the PROSPERA trial.

1. Problem Statement

The study addresses the escalating burden of Cardiovascular Disease (CVD), which threatens healthcare system sustainability. In the Netherlands, primary care practices (specifically practice nurses) deliver two-thirds of CVD-related care. However, current management strategies face two critical challenges:

• Resource Constraints: Increasing staffing shortages in primary care.
• Heterogeneity: The diverse nature of the patient population at risk requires more tailored approaches than current "one-size-fits-all" strategies can provide.
  There is an urgent need for risk management strategies that are better adapted to individual patient needs and risk profiles within the existing primary care infrastructure.

2. Methodology

The PROSPERA study is designed as a pragmatic, 1:1 cluster-randomized controlled trial (cRCT).

• Setting & Sample:
  • Location: 22 primary care practices in the greater Leiden and The Hague regions of the Netherlands.
  • Participants: Patients aged 40–90 years enrolled in integrated care programs for increased cardiovascular risk.
  • Data Infrastructure: Utilizes the Extramural Leiden Medical Center Academic Network (ELAN) for comprehensive healthcare data collection.
• Intervention (PROSPERA Program):
  A multilevel complex intervention designed to be integrated into clinical workflows, consisting of four components:
  1. Population Level: Risk stratification to identify high-risk groups.
  2. Professional Level: Training for healthcare professionals focused on cardiovascular risk communication.
  3. Patient Level (Self-Assessment): A lifestyle questionnaire ("Lifestylecheck").
  4. Clinical Level: A Clinical Decision Support Tool (CDST) known as U-Prevent.
• Control Group: Receives "care as usual."
• Study Duration & Outcomes:
  • Follow-up: 18 months.
  • Primary Outcome: The difference in the proportion of patients achieving all protocol-defined cardiovascular preventive treatment goals between the intervention and control groups.
  • Secondary Outcomes: Implementation outcomes, healthcare professional satisfaction/usability, patient experience (shared decision-making, decisional conflict), and cost-effectiveness.
• Ethical Considerations:
  • Routine healthcare data use: Opt-out consent procedure.
  • Study questionnaires: Digital informed consent.

3. Key Contributions

• Stakeholder Co-Development: The intervention was refined through a preceding qualitative study and co-developed with stakeholders, ensuring high integration with existing clinical workflows.
• Pragmatic Design: The study employs a broad inclusion criteria for the at-risk population, enhancing the representativeness and inclusivity of the findings for real-world application.
• Multilevel Approach: Unlike single-focus interventions, PROSPERA targets the system (risk stratification), the provider (training), and the patient (tools/questionnaires) simultaneously.
• Data Infrastructure: Leverages the ELAN network to enable robust, comprehensive data collection across multiple practices.

4. Results

• Status: As this document is a protocol paper, no clinical results or efficacy data are reported yet.
• Expected Deliverables: The study aims to generate findings on the effectiveness, efficacy, and implementation success of the PROSPERA program, which will be disseminated via peer-reviewed journals and conferences upon completion.

5. Significance and Limitations

• Significance:
  • Systemic Impact: If successful, the program offers a scalable model to improve CVD risk management in primary care, potentially alleviating pressure on healthcare systems and improving patient outcomes through personalized care.
  • Real-World Evidence: The pragmatic nature of the trial ensures that findings are directly applicable to routine clinical practice rather than just controlled research settings.
• Limitations:
  • IT Complexity: The current prototype of the information and technology (IT) infrastructure is complex, though this is expected to be simplified in future iterations.
  • Contamination Risk: Due to the nature of primary care networks, there is a risk of cross-over contamination, where control practices might gain informal access to PROSPERA components, potentially diluting the observed effect size.

Conclusion

The PROSPERA trial represents a significant step toward modernizing cardiovascular care in primary settings. By combining risk stratification, professional training, and digital decision support tools within a rigorous cluster-randomized framework, it seeks to validate a comprehensive strategy for managing CVD risk in a resource-constrained environment. The study is registered under NCT06593704.