Developing Flexible EHR Plug-ins to Re-Engineer Clinical Care and Research Workfl

描述(由申请人提供)：项目摘要临床医生科学家将临床观察转化为临床研究，并最终实现医学进步。然而，缺乏时间、培训和有效的技术支持是超过87%的初级保健医生进行研究的已知障碍1，2。我们的目标是通过赋予低社会经济社区的临床医生参与一线临床研究的权力，缩小初级保健和临床研究中的健康差距。我们建议为电子健康记录(EHR)开发灵活的插件，以帮助重新设计临床护理和研究工作流程，以提高工作流程效率和患者安全，并减少冗余。 临床研究和患者护理之间的流程和系统互操作性不足可能导致昂贵的重复测试订单和访问，以及危险的药物-药物相互作用。2009年，Conway和Clancy提出，“如果将必要的研究作为护理提供的副产品来使用，将是最有效和最相关的。”(《JAMA 09》，第301卷，第7期)临床护理和研究工作流程的有意义的融合有望避免冲突，并提高临床研究的安全性和效率。支持临床研究和患者护理之间灵活的数据联合和工作流程协调的电子病历插件将：(A)提高护理提供者和研究人员的背景意识；(B)通过保护研究参与者免受临床处方和研究干预之间的不良药物相互作用的影响，为他们促进一个更安全的环境；(C)通过消除多余或冲突的测试或访问，提高工作流程效率；以及(D)实现护理和研究团队之间的协同协调。一线临床医生科学家还可以作为学习网络，加速将临床研究证据传播到实践中。 在过去的十年中，我们的团队已经建立了提高临床或研究工作流程效率的成熟技术，包括基于电子病历的临床研究参与者筛选4、研究方案5-8和临床指南9的计算机化表示，以及集成的研究访问计划和财务管理工具STEPS10，仅举几例。通过我们的试验间研究10-13，NIH重新设计临床研究企业路线图的初始计划之一14，我们积累了关于临床研究工作流程的宝贵知识，并确定了社区临床研究11-13的信息学支持的实际需求。鉴于国家从2009年开始大规模部署电子健康记录，我们有动力将上述知识转化为敏捷的研究决策支持方法，可以灵活地与大多数职能的电子健康记录机构合作，直接满足社区层面的研究需求。因此，我们的具体目标是： 1.创建协调一致的患者护理和临床研究工作流程模型，旨在促进患者护理和临床研究之间的意识、信息共享和重复使用以及活动协调； 2.建立基于标准的业务规则知识库，通过协调多个利益相关者的用户需求来支持重新设计的护理/研究工作流模型； 3.设计了一个灵活的、可扩展的面向服务的体系结构，可以与业务规则知识库和电子病历互操作，为访问计划、不良事件检测、自动填写研究表格和研究参与者筛选提供研究决策支持； 4.设计和应用衡量标准，以评估多个利益相关者之间集成的工作流和研究决策支持方法的效用、可用性、有用性、影响和用户感知。 我们将在临床研究人员、临床研究协调员和生物医学信息学研究人员之间建立多学科合作，以实现上述目标。我们的社会技术方法结合了最好的领域知识、用户需求和先进的信息学技术来支持临床研究，基于我们的理解，即信息技术本身不足以改善工作流程，必须由所有利益相关者的需求和各种社会技术因素驱动。我们相信，我们建议的研究将大大提高社区实践环境中的比较有效性研究的能力，并提高临床研究的效率、安全性和种族多样性，最终有助于完成转化性研究任务，缩小健康差距。

DESCRIPTION (provided by applicant): Project Summary Clinician scientists transform clinical observations to clinical research and eventually medical advances. How- ever, the lack of time, training, and effective technology support are known barriers for more than 87% of primary care physicians to conduct research1, 2. Our goal is to diminish health disparities in primary care and clinical research by empowering clinicians in low socioeconomic communities to participate in frontline clinical research. We propose to develop flexible plug-ins for electronic health records (EHR) to help re-engineer clinical care and research workflows toward improved workflow efficiency and patient safety as well as reduced redundancy. Inadequate interoperability of processes and systems between clinical research and patient care can lead to costly redundant test orders and visits, and dangerous drug-drug interactions. In 2009, Conway and Clancy suggested that "use of requisite research will be most efficient and relevant if generated as a by-product of care delivery." (JAMA 09, Vol. 301, No.7). A meaningful fusion of clinical care and research workflows promises to avoid conflicts and to improve safety and efficiency for clinical research3. EHR plug-ins that support flexible data federation and workflow coordination between clinical research and patient care would (a) improve contextual awareness for both care providers and research personnel, (b) promote a safer environment for re- search participants by protecting them from adverse drug interactions between clinical prescriptions and re- search interventions, (c) improve workflow efficiency by eliminating redundant or conflicting tests or visits, and (d) enable synergetic coordination across care and research teams. Frontline clinician scientists could also serve as learning networks for accelerating dissemination of clinical research evidence into practice. Over the past decade, our team has established mature technology for improving the efficiency of clinical or research workflows, including EHR-based clinical research participants screening4, computerized representation of research protocols5-8 and clinical guidelines9, and an integrated research visit scheduling and financial management tool STEPS10, to name a few. Through our InterTrial research10-13, one of the NIH Roadmap initi- atives for re-engineering clinical research enterprise14, we have accumulated invaluable knowledge of clinical research workflows and identified practical needs for informatics support for community-based clinical re- search11-13. Given the nation's large-scale deployment of EHR starting year 2009, we are motivated to translate the above knowledge into agile research decision support methods that can flexibly work with most functional EHRs to directly address the research needs at community level. Therefore, our specific aims are to: 1. Create concerted patient care and clinical research workflow models, designed to promote awareness, information sharing and reuse, and activity coordination between patient care and clinical research; 2. Establish a standards-based knowledge base of business rules to support the re-engineered care/research workflow model by harmonizing the user needs of multiple stakeholders; 3. Design a flexible and scalable service-oriented architecture that can interoperate with the knowledge base of business rules and the EHR to provide research decision support for visit scheduling, adverse events detection, automated research form filling, and research participants screening; 4. Design and apply metrics to evaluate the utility, usability, usefulness, impact, and user perception of the integrated workflow and research decision support method among multiple stakeholders. We will build on a multidisciplinary collaboration between clinical investigators, clinical research coordinators, and biomedical informatics researchers to achieve the above aims. Our socio-technical approach marries the best of domain knowledge, user needs, and advanced informatics technology to support clinical research based on our understanding that information technology in itself is insufficient to improve workflows but must be driven by the needs of all stakeholders and various socio-technical factors. We believe our proposed research will substantially increase the capacity of comparative effectiveness research in community-based practice settings and improve the efficiency, safety, and ethnic diversity of clinical research, and ultimately help accomplish the translational research mission and bridge health disparity gaps.