Design and study protocol for a cluster randomized trial of a multi-faceted implementation strategy to increase the uptake of the USPSTF hypertension screening recommendations: the EMBRACE study
Design and study protocol for a cluster randomized trial of a multi-faceted implementation strategy to increase the uptake of the USPSTF hypertension screening recommendations: the EMBRACE study
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DOI：
10.1186/s13012-020-01017-8
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发表时间：
2020-08-08
影响因子：
7.2
通讯作者：
Kronish, Ian M.
中科院分区：
文献类型：
--
作者：
Moise, Nathalie;Phillips, Erica;Kronish, Ian M.
工作背景：美国预防服务工作组（USPSTF）建议在高血压诊断前进行门诊血压（BP）测试，以排除白色被毛高血压。尽管家庭和24小时动态血压监测（HBPM，ABPM）的可用性和覆盖率有所提高，但两者都很少用于确认诊断。我们使用行为改变轮（BCW）框架，一个多步骤的过程，映射理论知情的行为改变技术的障碍，开发一个多组件的实施策略，增加门诊血压测试高血压诊断。通过地理位置不同的提供者焦点小组（n = 63）探索办公室外测试和关键线人访谈（n = 12）的障碍，一个多学科团队（医学，心理学，护理学）使用严格的混合方法来开发，完善，局部适应，本报告的目的是描述一个多因素影响的议定书，在初级保健环境（EMBRACE）试验中对血液压力作用的多方面干预，这是一项群集随机对照试验，评估理论知情的多组分策略是否增加了高血压诊断的门诊外测试。EMBRACE试验患者样本将包括所有年龄≥ 18岁的成年人，在研究诊所的初级保健提供者的计划访视时，新升高的办公室血压（>= 140/90 mmHg）。纳入了在入组的ACN初级保健诊所对成人初级保健患者进行计划访视的所有提供者。我们确定，最可行、最有效的实施策略将包括提供关于门诊检测的教育、如何进行门诊HBPM和ABPM检测的演示/指导、门诊检测完成率的反馈、通过计算机化临床决策支持（CDS）工具提供的环境提示/线索，以及文化定制的、本地可获得的ABPM检测服务。我们目前正在比较的效果，这种本地适应的多组分策略与常规护理的变化，符合条件的患者谁完成了办公室外BP测试在1：1的群集随机试验在8个社会经济上不同的clinics.Conclusions的比例：EMBRACE试验是第一次试验，以测试实施策略，提高办公室外测试高血压诊断。它将阐明除了提供ABPM检测服务之外，通过教育、提醒和决策支持来定位提供者行为的程度将改善ABPM和HBPM的转诊和完成。
Background: 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.Conclusions: 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.