Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University Irving Medical Center, 622 W. 168th Street, New York, NY, 10032, USA.
Division of General Internal Medicine, Weill Cornell Medicine, 1320 York Avenue, New York, NY, 10021, USA.
Implement Sci. 2020 Aug 8;15(1):63. doi: 10.1186/s13012-020-01017-8.
The US Preventive Services Task Force (USPSTF) recommends out-of-office blood pressure (BP) testing to exclude white coat hypertension prior to hypertension diagnosis. Despite improved availability and coverage of home and 24-h ambulatory BP monitoring (HBPM, ABPM), both are infrequently used to confirm diagnoses. We used the Behavior Change Wheel (BCW) framework, a multi-step process for mapping barriers to theory-informed behavior change techniques, to develop a multi-component implementation strategy for increasing out-of-office BP testing for hypertension diagnosis. Informed by geographically diverse provider focus groups (n = 63) exploring barriers to out-of-office testing and key informant interviews (n = 12), a multi-disciplinary team (medicine, psychology, nursing) used rigorous mixed methods to develop, refine, locally adapt, and finalize intervention components. The purpose of this report is to describe the protocol of the Effects of a Multi-faceted intervention on Blood pRessure Actions in the primary Care Environment (EMBRACE) trial, a cluster randomized control trial evaluating whether a theory-informed multi-component strategy increased out-of-office testing for hypertension diagnosis.
METHODS/DESIGN: The EMBRACE Trial patient sample will include all adults ≥ 18 years of age with a newly elevated office BP (≥ 140/90 mmHg) at a scheduled visit with a primary care provider from a study clinic. All providers with scheduled visits with adult primary care patients at enrolled ACN primary care clinics were included. We determined that the most feasible, effective implementation strategy would include delivering education about out-of-office testing, demonstration/instruction on how to perform out-of-office HBPM and ABPM testing, feedback on completion rates of out-of-office testing, environmental prompts/cues via computerized clinical decision support (CDS) tool, and a culturally tailored, locally accessible ABPM testing service. We are currently comparing the effect of this locally adapted multi-component strategy with usual care on the change in the proportion of eligible patients who complete out-of-office BP testing in a 1:1 cluster randomized trial across 8 socioeconomically diverse clinics.
The EMBRACE trial is the first trial to test an implementation strategy for improving out-of-office testing for hypertension diagnosis. It will elucidate the degree to which targeting provider behavior via education, reminders, and decision support in addition to providing an ABPM testing service will improve referral to and completion of ABPM and HBPMs.
Clinicaltrials.gov , NCT03480217 , Registered on 29 March 2018.
美国预防服务工作组（USPSTF）建议在高血压诊断前进行非诊室血压（BP）检测以排除白大衣高血压。尽管家庭和 24 小时动态血压监测（HBPM、ABPM）的可用性和覆盖范围都有所提高，但两者都很少用于确诊。我们使用行为改变车轮（BCW）框架，这是一种多步骤的理论指导行为改变技术映射障碍的过程，为增加高血压诊断的非诊室 BP 检测制定了多组件实施策略。通过对 63 名来自不同地理区域的提供者焦点小组（n=63）的探索性研究，了解了非诊室检测的障碍以及关键知情人访谈（n=12），一个多学科团队（医学、心理学、护理）使用严格的混合方法开发、完善、本地化调整和最终确定干预措施。本报告的目的是描述 Effects of a Multi-faceted intervention on Blood pRessure Actions in the primary Care Environment（EMBRACE）试验的方案，这是一项集群随机对照试验，评估了基于理论的多成分策略是否增加了高血压诊断的非诊室检测。
方法/设计：EMBRACE 试验的患者样本将包括所有在预约就诊时新发现的诊室血压升高（≥140/90mmHg）的年龄在 18 岁及以上的成年人，这些患者均来自研究诊所的初级保健提供者。所有参与该研究的初级保健诊所的成年初级保健患者都包括在内。我们确定最可行和有效的实施策略将包括提供关于非诊室检测的教育，演示/说明如何进行非诊室 HBPM 和 ABPM 检测，反馈非诊室检测完成率，通过计算机临床决策支持（CDS）工具提供环境提示/线索，以及提供文化上合适、当地可获得的 ABPM 检测服务。我们目前正在比较这种经过本地化调整的多成分策略与常规护理对改变符合条件的患者完成非诊室 BP 检测的比例的影响，这是在 8 个社会经济多样化诊所进行的 1:1 集群随机试验。
EMBRACE 试验是首个测试改善高血压诊断中非诊室检测的实施策略的试验。它将阐明通过教育、提醒和决策支持来针对提供者行为，以及提供 ABPM 检测服务，将在多大程度上改善 ABPM 和 HBPM 的转诊和完成情况。
Clinicaltrials.gov，NCT03480217，于 2018 年 3 月 29 日注册。
