Care manager to control cardiovascular risk factors in primary care: the Raffaello cluster randomized trial

Objective: This cluster randomized trial evaluated the efficacy of a disease and care management (D&CM) model in cardiovascular (CVD) prevention in primary care. Methods: Eligible subjects had ≥1 among: blood pressure≥140/90 mmHg; glycated hemoglobin≥7%; LDL-cholesterol≥160 or ≥100 mg/dL (primary or secondary prevention, respectively); BMI≥30; current smoking. The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans. Control group was allocated to usual-care. The main outcome was the proportion of subjects achieving recommended clinical targets for ≥1 of uncontrolled CVD risk factors at 12-month. Results. During 2008-2009 we enrolled 920 subjects in Abruzzo/Marche regions, Italy. Following the exclusion of L'Aquila due to 2009 earthquake, final analyses included 762 subjects. The primary outcome was achieved by 39.1% (95%CI: 34.2-44.2) and 25.2% (95%CI: 20.9-29.9) of subjects in the intervention and usual-care group, respectively (p<0.001). The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension, with no differences in hypercholesterolemia, smoking status and obesity. Conclusions: The D&CM intervention was effective in controlling cardiovascular risk factors, in particular hypertension and diabetes. Numbers needed to treat were small. Such intervention may deserve further consideration in clinical practice.