A cluster randomized controlled trial to evaluate a disease and care-management intervention for cardiovascular prevention in primary care: The Raffaello Project.

The overall duration of interventions is 12 months. In Arm 1: The disease and care-management intervention evaluated is the “Care Management Team” (General Practitioner, Nurse as Care Manager, Patient and any Specialist needed) with the mission to define and apply tailored care plans for patients based on international guidelines on cardiovascular disease prevention. The intervention develops in 6 main steps: 1. Patient assessment. The GP assess patient health status and his/her cardiovascular risk. 2. Health goals definition. The GP sets health goals on the basis of evidence-based clinical recommendations. 3. Tailored health plan development. The GP and the CM elaborate a patient tailored health plan integrating clinical and care treatment goals, patient preferences and priorities and implementation strategies. 4. Patient education and support. The Care Manager deliver ongoing patient coaching, providing patients with information, motivation and support. Counselling occurs through recurrent telephone contacts and face-to-face meetings at the GP group practices. 5. Health plan implementation and results monitoring. The Care Manager manages counselling sessions, follow up visits, laboratory examinations, at frequency of patient recall established by health plan. 6. Periodic revision of healthcare plan. The Care Manager, in the light of the monitoring results, could adjust strategies and goals in agreement with the GP and the patient if necessary. Clinical decisional algorithms, based on international guidelines of cardiovascular disease prevention were used to guide Care Manager practice: the frequency of follow-up and laboratory examinations, when to refer to GP for drugs dosage adjustment/change or when to refer to specialists. In Arm 2: Control practices provided usual care.