Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized...

Area of Science:

• Primary Care Medicine
• Cardiology
• Pharmacology

Background:

• Antithrombotic therapy is crucial but requires careful safety management in general practice.
• Current management may not fully mitigate risks of thromboembolic and bleeding events.

Purpose of the Study:

• To evaluate a best-practice model integrating case management and patient education.
• To determine if this model reduces major thromboembolic and bleeding events in primary care.

Main Methods:

• 24-month cluster-randomized trial with 690 patients across 46 general practices.
• Intervention involves general practitioners, healthcare assistants, and patients using the Coagulation-Monitoring List (Co-MoL).
• Patients receive education and are motivated for self-management; control group receives usual care.

Main Results:

• Primary endpoint: combined incidence of major thromboembolic events and major bleeding complications.
• Secondary endpoints include mortality, stroke, hospitalization, and quality of life.
• Exploratory objectives assess adherence, knowledge, and satisfaction with shared decision-making.

Conclusions:

• Individual components like case management and self-management are proven effective.
• Combining these elements is expected to reduce major complications of antithrombotic treatment.
• The study aims to demonstrate the synergistic benefit of a comprehensive intervention model.