Cost effectiveness of a clinical decision support system based on the recommendations of the European Society of Cardiology and other societies for the Management of Hypercholesterolemia - Report of a cluster-randomized trial

Introduction and objectives: To assess the cost effectiveness of a clinical decision support system (CDSS) based on the recommendations of the European Society of Cardiology and other societies for Hypercholesterolemia Management (ESCHM). Study design and perspective: A cluster-randomized, unblinded, pragmatic trial was conducted. To assess the impact in effectiveness and costs of a CDSS implementing an adapted version of the ESCHM recommendations, a parallel comparison with a usual care group was carried out over 1 year. The recruitment period started in April 2000 and ended 1 year later. Effectiveness was defined as the achievement of the low-density lipoprotein-cholesterol (LDL-C) reduction goals in patients with initial cardiovascular risk (CVR) > 20% over 10 years (the goals being LDL-C < 115 mg/dL for patients with coronary heart disease [CHD], or LDL-C < 130 mg/dL for patients without CHD), or keeping CVR < 20% at study end in patients with initial CVR < 20%. The costs of treatments, visits, and laboratory assessments were estimated from the social perspective (year of costing 2002). Methods: The ESCHM guidelines adapted by a steering committee included therapeutic recommendations directed to achieve LDL-C objectives in a cost-effective manner. To promote healthy cardiovascular lifestyles, items such as table cloths and magnets for the refrigerator (with relevant promotional messages) were distributed to intervention practices. All study physicians recorded the patients' data in a specific-purpose application installed on their computer. In the case of intervention physicians, the CDSS was installed as an additional module of this application and they were requested to use it but were otherwise free to adopt or ignore the recommendations. Adherence to the guideline was monitored by the CDSS. Patients with hypercholesterolemia were selected from 44 general practices in Spain, mainly in the Catalonia region. Main outcome measures and results: 2221 patients were included in the study (1161 in usual care group and 1060 in the intervention group). The intervention was shown to be as effective as usual care, both in an unadjusted analysis and after adjusting for absolute CVR and previous treatment with lipid-lowering drugs (LLDs) [odds ratio (OR) 1.02; 95% Cl 0.58, 1.77]. The intervention had no impact on lipid profiles. Intervention patients were prescribed LLDs less frequently than usual care patients (OR = 0.37; 95% Cl 0.26, 0.52; p = 0.0001), particularly when CVR was low. This induced important savings in treatments (p = 0.0001) and total costs (p = 0.001), which were estimated as 24.9% and 20.8%, respectively. The intervention increased the number of laboratory analyses. The recommendations issued by the CDSS were accepted in 71.3% of the visits. Discussion and conclusions: The CDSS based on the recommendations of the ESCHM did not modify the effectiveness of usual care but induced considerable savings.