REACH: Research Empowerment for Adult Congenital Hearts

描述（由申请人提供）：目标：为患者驱动的全国成人先天性心脏病研究网络创建必要的信息技术、数据共享、教育和监督工具。目的：(1)通过建立区域结构和流程，促进有能力启动和维持这一进程的患者个人参与，并在国家层面收集患者需求和关注的评估，证明以患者为中心的先天性心脏病患者研究模式的可行性；(2)采用电子健康记录技术，通过建立专门为先天性心脏病从业者设计的统一电子健康记录，为先天性心脏病的多中心研究建立全国性的基础设施。然后通过电子健康数据，将去识别的临床数据提供给患者社区用于研究目的；(3)通过为研究提供患者驱动的假设建议，并通过患者机制而不是提供者来传播研究结果，从而增强成人先天性心脏病患者和研究人员之间研究需求和结果的双向沟通。背景：先天性心脏病是最常见的先天性缺陷，在过去的50年里，先天性心脏病的治疗取得了巨大的进步。他们的生存创造了一个新兴的成人先天性缺陷人群，并刺激了心脏病学中一个新的亚专科的形成，成人先天性心脏病（ACHD）。随着这一人群的出现，人们越来越认识到这些患者成年后仍有心血管问题。越来越清楚的是，儿童时期的手术并不等于“治愈”。心律失常、猝死、妊娠期并发症、瓣膜功能障碍、需要进一步手术、心力衰竭和心脏移植都是常见的结果，有时不能及时发现。随着这一患者群体在其未知的自然历史中不断衰老，他们发现，评估、研究和治疗其需求的有组织资源的缺乏令人担忧。与此同时，关注这一患者群体的医疗服务提供者认识到，在循证实践中存在巨大差距，而且缺乏开展必要研究的基础设施。该基金寻求资金来满足患者和提供者的需求，并巩固他们的共同努力，以实现在ACHD领域的卓越治疗的相同目标。方法：CONGENERATE的实施将在5个试点地点实施，每个试点地点都对实施提出了独特的挑战。将在1个初始站点和2个后续站点尝试与一个广泛使用的机构电子医疗记录系统（即EPIC）完全集成。将建立一个全国性的REACH资源中心，该中心将提供“工具包”，最终协助各种ACHD项目实施CONGENERATE，并协助将CONGENERATE作为免费下载提供给所有感兴趣的ACHD项目。患者参与的策略将包括：(1)通过创建一个基于网络的门户网站，允许上传受密码保护的CONGENERATE生成的电子病历，从而使CONGENERATE成为便携式电子健康记录；(2)召集多个论坛，以便患者和研究人员之间进行双向交流；(3)创建用于教育、参与和监督的社区基础设施。

DESCRIPTION (provided by applicant): Objectives: To create the IT, data-sharing, education, and oversight tools necessary for a patient-driven, national adult congenital heart disease research network. Aims: (1) To demonstrate the feasibility of a patient-centered research model for patients with congenital heart disease by building regional structure and process to foster individual participation by patients with the ability to initiate and sustain the process and collecting assessments of patient needs and concerns at the national level; (2) To employ electronic health record technology to create a national infrastructure for multicenter research in congenital heart disease through establishing a uniform electronic health record specifically designed for practitioners in ACHD. Then through the electronic health data, deidentified clinical data will be provided to the patient community for research purposes; and (3) To empower bidirectional communication of research needs and outcomes between adult congenital heart patients and investigators by providing patient-driven hypothesis proposals for research studies and circulating research results through patient-mechanisms rather than providers. Background: Patients born with congenital heart disease, the most common birth defect, have benefited from monumental advances in treatment over the past 5 decades. Their survival has created an emerging population of adults with congenital defects, and spurred the formation of a new sub-specialty in cardiology, Adult Congenital Heart Disease (ACHD). With the emergence of this population, there is growing recognition that the patients continue to have cardiovascular problems as adults. It is increasingly clear that prior surgery in childhood does not equal a "cure." Arrhythmias, sudden death, complications during pregnancy, valve dysfunction, need for further surgery, heart failure, and heart transplantation are all common outcomes, sometimes not recognized in a timely manner. As this patient community ages its way forward through its uncharted natural history, it is finding an alarming lack of organized resources to assess, study, and treat its needs. In parallel, the providers who focus on this patient group recognize huge gaps in evidence-based practice, and no infrastructure for building needed studies. This grant seeks funding to address both the patient and provider needs, and solidify their mutual efforts to meet the same goals of treatment excellence in the ACHD field. Methods: Implementation of CONGENERATE will be implemented at 5 pilot locations, each of which offer unique challenges to implementation. Full integration with one widely-used institutional electronic medical records system (i.e., EPIC) will be attempted at 1 initial and 2 subsequent sites. A national REACH resource center will be established which will provide "toolkits" to eventually assist a wide variety of ACHD programs in implementing CONGENERATE, and assist in making CONGENERATE available as a free download to all interested ACHD programs. Strategies for patient engagement will include (1) adapting CONGENERATE for usage as a portable electronic health record, by creating a web-based portal to allow upload of password- protected CONGENERATE-generated EHRs, (2) convening multiple forums for bidirectional communication between patients and researchers, and (3) creating community infrastructure for education, engagement, and oversight. PUBLIC HEALTH RELEVANCE: The REACH project seeks to create the information technology, data-sharing, education, and oversight tools necessary for a patient-driven, national adult congenital heart disease research network. It will employ electronic health record technology to provide deidentified clinical data to adult CHD practitioners, researchers and the patient community for long-term outcome research purposes while creating pathways for patient- involvement.