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急诊科未控制高血压目标治疗(TOUCHED):一项随机对照试验的设计。

Targeting of uncontrolled hypertension in the emergency department (TOUCHED): Design of a randomized controlled trial.

机构信息

Department of Emergency Medicine, University of Illinois, Chicago, IL, USA.

Department of Emergency Medicine and College of Pharmacy, University of Illinois, Chicago, IL, USA.

出版信息

Contemp Clin Trials. 2021 Mar;102:106283. doi: 10.1016/j.cct.2021.106283. Epub 2021 Jan 20.

Abstract

BACKGROUND

Uncontrolled or undiagnosed hypertension (HTN) is estimated to be as high as 46% in emergency departments (EDs). Uncontrolled HTN contributes significantly to cardiovascular morbidity and disproportionately affects communities of color. EDs serve high risk populations with uncontrolled conditions that are often missed by other clinical settings and effective interventions for uncontrolled HTN in the ED are critically needed. The ED is well situated to decrease the disparities in HTN control by providing a streamlined intervention to high risk populations that may use the ED as their primary care.

METHODS

Targeting of UnControlled Hypertension in the Emergency Department (TOUCHED), is a two-arm single site randomized controlled trial of 770 adults aged 18-75 presenting to the ED with uncontrolled HTN comparing (1) usual care, versus (2) an Educational and Empowerment (E2) intervention that integrates a Post-Acute Care Hypertension Consultation (PACHT-c) with a mobile health BP self-monitoring kit. The primary outcome is differences in mean systolic blood pressure (SBP) at 6-months post enrollment. Secondary outcomes include differences in mean SBP and mean diastolic BP (DBP) at 3-months and mean DBP at 6-months. Additionally, improvement in cardiovascular risk score, medication adherence, primary care engagement, and HTN knowledge will also be assessed as part of this study.

CONCLUSIONS

The TOUCHED trial will be instrumental in determining the effectiveness of a brief ED-based intervention that is portable to other urban EDs with high-risk populations.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT03749499.

摘要

背景

据估计,急诊科(ED)未得到控制或未经诊断的高血压(HTN)的比例高达 46%。未得到控制的 HTN 会显著增加心血管发病率,并不成比例地影响有色人种社区。ED 服务于高危人群,这些人群存在未经其他临床环境发现的未得到控制的疾病,ED 中急需针对未得到控制的 HTN 的有效干预措施。ED 是减少 HTN 控制差异的理想场所,通过为可能将 ED 作为其初级保健的高危人群提供简化干预措施来实现这一目标。

方法

急诊科未控制高血压的靶向治疗(TOUCHED)是一项针对 770 名年龄在 18-75 岁之间的成年人的两臂单站点随机对照试验,这些成年人因未得到控制的 HTN 而到 ED 就诊,比较(1)常规护理,与(2)教育和赋权(E2)干预,该干预措施将急性后护理高血压咨询(PACHT-c)与移动健康 BP 自我监测套件相结合。主要结局是在入组后 6 个月时平均收缩压(SBP)的差异。次要结局包括 3 个月和 6 个月时平均 SBP 和平均舒张压(DBP)的差异。此外,心血管风险评分的改善、药物依从性、初级保健参与和 HTN 知识也将作为该研究的一部分进行评估。

结论

TOUCHED 试验将有助于确定一种基于 ED 的简短干预措施的有效性,这种干预措施对其他具有高危人群的城市 ED 具有便携性。

试验注册

clinicaltrials.gov 标识符:NCT03749499。

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