HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.
HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.
Contemp Clin Trials. 2020 May;92:105939. doi: 10.1016/j.cct.2020.105939. Epub 2020 Jan 22.
Uncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S.
Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care.
AIMS/OBJECTIVES: To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research.
The design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18-85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects.
This pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings.
在美国，未得到控制的高血压是导致全因和心血管死亡率的最大单一因素。
护士和药剂师主导的团队式护理和远程医疗护理干预措施已被证明可显著且持久地改善血压（BP）；然而，尚不清楚在现实环境中如何成功地大规模实施这些措施。远程医疗干预措施如何影响患者体验与传统基于诊所的护理相比也不确定。
目的/目标：比较两种基于证据的血压护理策略在初级保健环境中的效果：（1）最佳实践的基于诊所的护理，（2）通过临床药剂师进行家庭血压远程监测和管理的远程医疗护理。使用基于混合方法的 RE-AIM 框架和实施研究综合框架进行评估。
该设计是一项在 21 个初级保健诊所（9 个基于诊所的护理，12 个远程医疗护理）中进行的集群随机比较有效性实用试验。如果在两次连续就诊时血压升高至≥150/95mmHg，则通过自动化电子健康记录（EHR）工具在初级保健就诊期间招募患有高血压的成年患者（年龄 18-85 岁）。主要结局是从 EHR 中提取的 12 个月内收缩压的变化。次要结局是通过调查测量的 6 个月内关键患者报告结果的变化。在不同时间点收集定性数据，以调查实施障碍并解释干预效果。
这项实用试验旨在为卫生系统提供信息，了解在现实世界的初级保健环境中实施家庭血压远程监测和药剂师管理对未控制高血压的益处、优势和局限性。
