Achieving cholesterol target in a managed care organization (ACTION) trial

Study Objectives. To objectively compare the results of a collaborative approach using pharmacists with the results of usual care for achieving a low-density lipoprotein cholesterol (LDL) goal of 100 mg/dl or less in outpatients with documented coronary heart disease (CHD) who are not at goal, and to document the effect on LDL after removal of such a collaborative model from the study population. Design. Prospective, multiclinic, controlled study. Setting. Four clinics of a 19-clinic staff model health maintenance organization in Minneapolis and St. Paul, Minnesota. Two clinics treated the intervention patients, two the controls; one clinic for each group was suburban, and one for each was urban. Patients. Four hundred eighty-one patients aged 18 years or older with CHD and whose LDL levels were not at goal. Intervention. Clinical pharmacists implemented the physician-approved care plan for each intervention patient; activities included managing lipid-lowering drug therapy and educating patients on cardiovascular risk reduction. Measurements and Main Results. Primary outcomes were changes in LDL level and the proportion of patients achieving goal LDL in the intervention versus the usual care (control) group. Secondary outcomes were the sustainability of the impact observed up to 18 months after discontinuation of the intervention. Mean ± SD baseline LDL levels were 131 + 28 and 131 ± 26 mg/dl (p=NS) for the intervention and control groups, respectively. After a mean of 6.5 months follow-up, 107 (72%) patients in the intervention group and 61 (18%) patients in the control group had attained their LDL goal (p<0.001). Mean LDL levels were reduced by 35.6 mg/dl (27.5%) and 6.7 mg/dl (4.6%) in the intervention and control groups, respectively (p<0.001). When the active program was discontinued, results of the 18-month follow-up indicated that 85 (65%) intervention patients remained at goal compared with 96 (42%) controls (p<0.001). Conclusion. This trial provides quantitative evidence to support the effectiveness of the collaborative approach as an intervention to optimize management of patients with CHD whose LDL levels are not at goal; this approach is specifically called for in the executive summary of the National Cholesterol Education Program Adult Treatment Panel III. Furthermore, this study documents both the magnitude and sustainability of the impact collaborative care models can have in managed care environments.