目的:评估临床决策支持系统(CDSS)在改善中国初级医疗机构中指南一致的抗高血压治疗的有效性。
方法:务实,开放标签,集群随机试验。
方法:2019年8月至2022年7月期间,中国四个城市地区的94项初级保健实践:洛阳(中国中部),济宁(华东),和深圳(华南,包括两个区域)。
方法:94个实践是随机的(46到CDSS,48到常规护理)。纳入了12137名高血压患者,他们使用了多达两类抗高血压药物,收缩压<180mmHg,舒张压<110mmHg。
方法:初级保健实践随机使用基于电子健康记录的CDSS,它推荐了一个具体的指导方针,滴定,或转换抗高血压药(干预),或在没有CDSS的情况下使用相同的电子健康记录,并照常提供治疗(对照)。
方法:主要结局是高血压相关就诊的比例,在此期间提供了适当的(指南一致)治疗。次要结果是收缩压的平均降低和最后一次计划随访时血压控制(<140/90mmHg)的参与者比例。安全性结果为患者报告的降压治疗相关事件,包括晕厥,伤害性坠落,症状性低血压或收缩压<90mmHg,和心动过缓.
结果:5755名参与者,干预组23113次访问,对照组6382名参与者,27868次访问。平均年龄为61(标准差13)岁,女性占42.5%。在中位11.6个月的随访期间,干预组给予适当治疗的就诊比例高于对照组(77.8%(17975/23113)对62.2%(17328/27868);绝对差异15.2个百分点(95%置信区间(CI)10.7~19.8);P<0.001;比值比2.17(95%CI1.75~2.69;P<0.001).与对照组的参与者相比,干预组患者收缩压降低1.6mmHg(95%CI-2.7~-0.5)(-1.5mmHgv0.3mmHg;P=0.006),血压控制率提高4.4个百分点(95%CI-0.7~9.5)(69.0%(3415/4952)v64.6%(3778/5845);P=0.07).两组患者报告的降压治疗相关不良反应均罕见。
结论:在中国初级保健中使用CDSS改善了指导一致的抗高血压治疗的提供,并导致血压适度降低。CDSS提供了一种有希望的方法来提供更好的高血压护理,既安全又高效。
背景:ClinicalTrials.govNCT03636334。
To evaluate the effectiveness of a clinical decision support system (CDSS) in improving the use of
guideline accordant antihypertensive treatment in primary care settings in China.
Pragmatic, open label, cluster randomised trial.
94 primary care practices in four urban regions of China between August 2019 and July 2022: Luoyang (central China), Jining (east China), and Shenzhen (south China, including two regions).
94 practices were randomised (46 to CDSS, 48 to usual care). 12 137 participants with hypertension who used up to two classes of antihypertensives and had a systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg were included.
Primary care practices were randomised to use an electronic health record based CDSS, which recommended a specific
guideline accordant regimen for initiation, titration, or switching of antihypertensive (the intervention), or to use the same electronic health record without CDSS and provide treatment as usual (control).
The primary outcome was the proportion of hypertension related visits during which an appropriate (
guideline accordant) treatment was provided. Secondary outcomes were the average reduction in systolic blood pressure and proportion of participants with controlled blood pressure (<140/90 mm Hg) at the last scheduled follow-up. Safety outcomes were patient reported antihypertensive treatment related events, including syncope, injurious fall, symptomatic hypotension or systolic blood pressure <90 mm Hg, and bradycardia.
5755 participants with 23 113 visits in the intervention group and 6382 participants with 27 868 visits in the control group were included. Mean age was 61 (standard deviation 13) years and 42.5% were women. During a median 11.6 months of follow-up, the proportion of visits at which appropriate treatment was given was higher in the intervention group than in the control group (77.8% (17 975/23 113) v 62.2% (17 328/27 868); absolute difference 15.2 percentage points (95% confidence interval (CI) 10.7 to 19.8); P<0.001; odds ratio 2.17 (95% CI 1.75 to 2.69); P<0.001). Compared with participants in the control group, those in the intervention group had a 1.6 mm Hg (95% CI -2.7 to -0.5) greater reduction in systolic blood pressure (-1.5 mm Hg v 0.3 mm Hg; P=0.006) and a 4.4 percentage point (95% CI -0.7 to 9.5) improvement in blood pressure control rate (69.0% (3415/4952) v 64.6% (3778/5845); P=0.07). Patient reported antihypertensive treatment related adverse effects were rare in both groups.
Use of a CDSS in primary care in China improved the provision of
guideline accordant antihypertensive treatment and led to a modest reduction in blood pressure. The CDSS offers a promising approach to delivering better care for hypertension, both safely and efficiently.
ClinicalTrials.gov NCT03636334.