Pouchain Denis, Lièvre Michel, Huas Dominique, Lebeau Jean-Pierre, Renard Vincent, Bruckert Eric, Girerd Xavier, Boutitie Florent
Service de Pharmacologie Clinique, Université Claude Bernard, CNRS UMR 5558, rue Guillaume Paradin, BP 8071, Lyon Cedex 08, 69376,, France.
Trials. 2013 Oct 1;14:318. doi: 10.1186/1745-6215-14-318.
Several observational studies on hypertensive patients have shown a gap between therapeutic targets recommended in guidelines and those achieved in daily practice. The ESCAPE trial aimed to determine whether a multifaceted intervention focused on general practitioners (GPs), could increase significantly the proportion of hypertensive patients at high risk in primary prevention who achieved all their recommended therapeutic targets.
A pragmatic, cluster randomized trial involving 257 GPs randomized by region. The GPs in the intervention group had a one-day training session and were given an electronic blood pressure measurement device and a short recommendation leaflet. Along with usual follow-up, they focused one consultation on hypertension and other cardiovascular risk factors every six months for two years. They also received feedback at baseline and at one year on their patients' clinical and biological parameters. Main outcome measures were change in the proportion of patients achieving all their therapeutic targets and each individual therapeutic target at two years, and quality of life.
1,832 high-risk hypertensive patients were included. After two years, the proportion of patients achieving all their therapeutic targets increased significantly in both groups, but significantly more in the intervention group: OR (odds-ratio) 1.89, (95% confidence interval (CI) 1.09 to 3.27, P = 0.02). Significantly more patients achieved their blood pressure targets in the intervention group than in the usual care group: OR 2.03 (95% CI 1.44 to 2.88, P < 0.0001). Systolic and diastolic blood pressures decreased significantly more in the intervention group than in the usual care group, by 4.8 mmHg and 1.9 mmHg, respectively (P < 0.0001 for both). There were no significant difference changes in physical and mental quality of life between groups.
An easy-to-perform, multifaceted intervention targeting only GPs increased significantly the proportion of high-risk hypertensive patients in primary prevention achieving their recommended therapeutic targets.
This trial was registered with ClinicalTrials.gov, number NCT00348855.
多项针对高血压患者的观察性研究表明，指南推荐的治疗目标与日常实践中所达到的目标之间存在差距。ESCAPE试验旨在确定一项针对全科医生（GP）的多方面干预措施是否能显著提高一级预防中高危高血压患者达到所有推荐治疗目标的比例。
一项实用的整群随机试验，涉及按地区随机分组的257名全科医生。干预组的全科医生参加了为期一天的培训课程，并获得了一台电子血压测量设备和一份简短的推荐手册。除了常规随访外，他们在两年内每六个月针对高血压和其他心血管危险因素进行一次会诊。他们还在基线时和一年时收到关于其患者临床和生物学参数的反馈。主要结局指标为两年时达到所有治疗目标和每个个体治疗目标的患者比例变化以及生活质量。
纳入了1832例高危高血压患者。两年后，两组中达到所有治疗目标的患者比例均显著增加，但干预组增加得更为显著：比值比（OR）为1.89，（95%置信区间（CI）为1.09至3.27，P = 0.02）。干预组中达到血压目标的患者显著多于常规护理组：OR为2.03（95%CI为1.44至2.88，P < 0.0001）。干预组的收缩压和舒张压下降幅度分别比常规护理组显著多4.8 mmHg和1.9 mmHg（两者P < 0.0001）。两组之间在身体和心理生活质量方面没有显著差异变化。
一项仅针对全科医生的易于实施的多方面干预措施显著提高了一级预防中高危高血压患者达到推荐治疗目标的比例。
本试验已在ClinicalTrials.gov注册，编号为NCT00348855。
