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家庭血压远程监测和药师管理对血压控制的影响:一项集群随机临床试验。

Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial.

机构信息

HealthPartners Institute for Education and Research, Minneapolis, Minnesota 55440, USA.

出版信息

JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.

Abstract

IMPORTANCE

Only about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension.

OBJECTIVES

To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped.

DESIGN, SETTING, AND PATIENTS: A cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up.

INTERVENTIONS

Eight clinics were randomized to provide usual care to patients (n = 222) and 8 clinics were randomized to provide a telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly.

MAIN OUTCOMES AND MEASURES

Control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (<130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped).

RESULTS

At baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P = .001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P = .003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P<.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P<.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P = .004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P<.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P<.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P = .07).

CONCLUSIONS AND RELEVANCE

Home BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00781365.

摘要

重要性

在美国,只有大约一半的高血压患者血压得到控制。需要实用、稳健和可持续的模式来改善未经控制的高血压患者的血压控制。

目的

确定将家庭血压远程监测与药剂师病例管理相结合的干预措施是否比常规护理更能改善血压控制,并确定干预停止后血压控制是否得以维持。

设计、设置和患者:这项多中心临床试验纳入了来自明尼苏达州明尼阿波利斯-圣保罗市综合医疗系统的 16 个初级保健诊所的 14692 名电子病历患者中的 450 名血压控制不佳的成年人,这些患者随机分为 8 个诊所接受常规护理(n=222)和 8 个诊所接受远程监测干预(n=228)。干预组患者接受家庭血压远程监测,并将血压数据传输给药剂师,后者相应调整降压治疗。

主要结局和测量指标

6 个月和 12 个月时收缩压<140 mm Hg 和舒张压<90 mm Hg(糖尿病或慢性肾脏病患者<130/80 mm Hg)的控制情况。次要结局为血压变化、患者满意度以及干预停止后 6 个月(18 个月)的血压控制情况。

结果

在基线时,入组患者中 45%为女性,82%为白人,平均(SD)年龄为 61.1(12.0)岁,平均收缩压为 148 mm Hg,舒张压为 85 mm Hg。在远程监测干预组中,6 个月和 12 个月时血压得到控制的患者比例分别为 57.2%(95% CI,44.8%至 68.7%)和 57.2%(95% CI,44.8%至 68.7%),而常规护理组中这一比例分别为 30.0%(95% CI,23.2%至 37.8%)(P=0.001)。在 18 个月(干预停止后 6 个月的随访)时,远程监测干预组中血压得到控制的患者比例为 71.8%(95% CI,65.0%至 77.8%),而常规护理组中这一比例为 57.1%(95% CI,51.5%至 62.6%)(P=0.003)。与常规护理组相比,远程监测干预组患者的收缩压在 6 个月(-10.7 mm Hg [95% CI,-14.3 至-7.3 mm Hg];P<0.001)、12 个月(-9.7 mm Hg [95% CI,-13.4 至-6.0 mm Hg];P<0.001)和 18 个月(-6.6 mm Hg [95% CI,-10.7 至-2.5 mm Hg];P=0.004)时的降幅更大。与常规护理组相比,远程监测干预组患者的舒张压在 6 个月(-6.0 mm Hg [95% CI,-8.6 至-3.4 mm Hg];P<0.001)、12 个月(-5.1 mm Hg [95% CI,-7.4 至-2.8 mm Hg];P<0.001)和 18 个月(-3.0 mm Hg [95% CI,-6.3 至 0.3 mm Hg];P=0.07)时的降幅更大。

结论和相关性

家庭血压远程监测和药剂师病例管理与常规护理相比,在 12 个月的干预期间实现了更好的血压控制,并且在干预停止后的 6 个月随访期间仍然保持。

试验注册

clinicaltrials.gov 标识符:NCT00781365。

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