Design and Testing of a Mobile Cardiovascular Risk Service with Patient Partners

 心血管疾病（CVD）每天在美国造成2，200人死亡，每39秒就有一人死亡。有证据表明，这些死亡是可以通过更好的风险因素管理来预防的，但是，许多风险因素仍然不受控制。以病人为中心的医疗之家（医疗之家），其中包括自我管理，个性化的健康记录和团队为基础的护理，已被提出作为一项战略，以减少这些差距，在提供护理。几项科克伦综述和荟萃分析发现，有证据表明，在初级保健团队中增加药剂师可以改善风险因素控制和医生对指南的依从性。管理式医疗组织发现，由药剂师管理的集中式心血管风险服务（CVRS）可以降低死亡率。文献中的一个空白是，目前尚不清楚是否会在非一体化环境中的典型办公室实践中实施全面的CVRS模型。同时，对包括疾病管理应用程序在内的移动的健康（mHealth）试验进行的系统性综述发现，没有一项试验与药剂师进行了沟通，缺乏证据是mHealth文献中的一个主要空白。本应用程序的目的是开发和测试一个支持移动的应用程序的药剂师管理的CVRS，用于在实践中传播和实施循证指南。除了与患者作为设计合作伙伴开发应用程序外，我们还将 在具有较大地理、种族和民族多样性的医疗办公室进行一项嵌套在正在进行的NIH试验中的多中心个体随机研究。我们将从初级保健办公室随机分配100例患者至mHealth CVRS（移动的应用程序+网站+药剂师）或仅CVRS（网站+药剂师），其中55例患者将来自少数种族/民族。我们的中心假设是，将实施以患者为合作伙伴设计的mHealth CVRS，并显著提高患者参与度，从而使用“遵循指南”和“指南优势”指标提高CVD指南的依从性。这项拟议研究的基本原理是，一种新的mHealth模式，在药剂师的帮助下改善了CVD的二级预防，将导致美国各地的卫生系统更广泛地采用。我们的主要目标是：在一项前瞻性随机对照试验中，在不同的初级保健办公室中，研究移动健康技术传播基于证据的风险降低指南的可行性。我们假设，与对照组相比，随机分配到mHealth干预的患者的系统参与（主要假设）和对CVD二级预防指南的依从性（次要假设）将显著更高。本研究预计将产生以下结局：补充标准CVRS的独特移动的应用程序功能，增加与CVRS的参与，并增加指南一致性治疗的实现。

 DESCRIPTION (provided by applicant): Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. There is evidence that these deaths can be prevented with better risk factor management, however, many risk factors remain uncontrolled. The Patient-Centered Medical Home (Medical Home) which includes self-management, personalized health records and team-based care, has been proposed as a strategy to reduce these gaps in care delivery. Several Cochrane reviews and meta-analyses have found evidence that adding pharmacists to the primary care team improves risk factor control and physician adherence to guidelines. Managed care organizations have found that a centralized cardiovascular risk service (CVRS) managed by pharmacists can reduce mortality. A gap in the literature is that it is not known whether a comprehensive CVRS model would be implemented in typical office practices in un-integrated settings. Simultaneously, systematic reviews of mobile health (mHealth) trials including disease management apps have found no trial that has incorporated communication with a pharmacist and this lack of evidence is a major gap in the mHealth literature. The objective of this application is to develop and test a mobile app enabled, pharmacist managed CVRS for disseminating and implementing evidence-based guidelines in practice. In addition to developing the app with patients as design partners, we will conduct a multi-center individually randomized study nested within an ongoing NIH trial in medical offices with large geographic, racial and ethnic diversity. We will randomize 100 patients from primary care offices to mHealth CVRS (mobile app + web site + pharmacist) or to CVRS only (web site + pharmacist) of whom 55 will be from racial/ethnic minorities. Our central hypothesis is that the mHealth CVRS designed with patients as partners will be implemented and significantly improve patient engagement, leading to improved CVD guideline adherence using the Get with The Guidelines and Guideline Advantage metrics. The rationale for this proposed study is that a novel mHealth model that improves secondary prevention of CVD with pharmacist assistance will lead to broader adoption by health systems throughout the US. Our primary Aim is: to examine the feasibility of mHealth technology to disseminate evidence- based risk reduction guidelines in a prospective randomized controlled trial among diverse primary care offices. We postulate that system engagement (primary hypothesis) and adherence to guidelines for secondary prevention of CVD (secondary hypothesis) will be significantly greater in patients randomized to the mHealth intervention compared to the control group. This study is expected to produce the following outcomes: unique mobile app features that complement the standard CVRS, increased engagement with a CVRS and increased achievement of guideline- concordant therapy.