CRISTOPH - a cluster-randomised intervention study to optimise the treatment of patients with hypertension in General Practice

CRISTOPH——一项旨在优化全科医疗中高血压患者治疗的整群随机干预研究

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Abstract

BACKGROUND: Recent guidelines for the management of hypertension focus on treating patients according to their global cardiovascular risk (CVR), rather than strictly keeping blood pressure, or other risk factors, below set limit values. The objective of this study is to compare the effect of a simple versus a complex educational intervention implementing this new concept among General Practitioners (GPs). METHODS/DESIGN: A prospective longitudinal cluster-randomised intervention trial with 94 German GPs consecutively enroling 40 patients each with known hypertension. All GPs then received a written manual specifically developed to transfer the global concept of CVR into daily General Practice. After cluster-randomisation, half of the GPs additionally received a clinical outreach visit, with a trained peer discussing with them the concept of global CVR referring to example study patients from the respective GP. Main outcome measure is the improvement of calculated CVR six months after intervention in the subgroup of patients with high CVR (but no history of cardiovascular disease), defined as 10-year-mortality > or = 5% employing the European SCORE formula. Secondary outcome measures include the intervention's effect on single risk factors, and on prescription rates of drugs targeting CVR. All outcome measures are separately studied in the three subgroups of patients with 1. high CVR (defined as above), 2. low CVR (SCORE < 5%), and 3. a history of cardiovascular disease. The influence of age, sex, social status, and the perceived quality of the respective doctor-patient-relation on the effects will be examined. DISCUSSION: To our knowledge, no other published intervention study has yet evaluated the impact of educating GPs with the goal to treat patients with hypertension according to their global cardiovascular risk. TRIAL REGISTRATION: ISRCTN44478543.

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