Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease

描述（由申请人提供）：我的职业目标是一个转化研究的职业生涯，改善在初级保健机构治疗的慢性肾脏病（CKD）患者的护理。我想开发并在试点随机对照试验（RCT）中测试一种基于理论的电子健康（“eHealth”）干预措施，目的是改变患者和临床医生的行为。干预将由多成分、多渠道（电子邮件、短信、在线视频）材料组成，旨在促进采用有效的药物。为了实现这些目标，我将学习生物统计学、临床试验、Meta分析、人类动机、营销技巧、心理干预、产品设计和数字医学等课程，以扩展我的技能。我也将大大受益于 我的指导团队为我提供了计划好的教程：1）斯塔福德博士（主要导师）临床医生处方模式和教育，流行病学分析，慢性病管理试验，负责任的研究，综合研究议程的开发和实施，职业网络和NIH拨款写作，2）Chertow博士（共同导师）关于最佳CKD管理以及CKD患者RCT的设计和管理，3）Bero博士（共同导师）在定性方法，临床药理学，研究综合，并将证据转化为实践，和4）马博士（共同导师）研究与电子健康记录，电子行为干预，和初级保健为基础的试验。为了完成研究计划，我们的团队将从三个相关的研究领域--药品广告、社会营销和增强处方医生教育--中调整经验支持的内容。内容将在一个综合的行为框架内进行调整，该框架将协同针对人类认知的双重处理系统，涉及受控和有目的处理的意识系统以及使用快速自动处理的情感系统。我们将招募的患者是那些在斯坦福大学或帕洛阿尔托医学基金会接受初级保健但尚未采用指定药物的中度CKD患者。在形成性研究的目的，我们将开发电子健康干预使用观察，系统回顾和定性的方法。在评价性研究目标期间，我们将在一项2组试点RCT（每组50例患者）中测试干预与常规治疗。主要结局将是12个月随访时评估CKD进展风险因素（蛋白尿、血压、血糖、胆固醇）控制的4点指标。假设电子健康干预组将比常规护理组实现更好的CKD风险因素控制。次要结局将包括新处方、CKD进展以及可行性和过程数据。电子健康干预措施的开发和测试产生的数据将指导R 01应用程序和其他相关研究中更大RCT的设计。电子健康干预有可能改善数百万尚未接受有效药物治疗的CKD患者的健康状况，并将其扩展到相关疾病。

DESCRIPTION (provided by applicant): My career goal is a translational research career that improves care for patients with chronic kidney disease (CKD) treated in primary care settings. I want to develop and then test in a pilot randomized controlled trial (RCT) a theory-based electronic health ("eHealth") intervention sent with the intention of changing the behavior of patients and clinicians. The intervention will be comprised of multicomponent, multichannel (e- mail, text message, online video) materials designed to prompt adoption of effective medications. To accomplish these goals, I will take courses to expand my skill set-those on biostatistics, clinical trials, meta- analysis, human motivation, marketing techniques, psychological interventions, product design, and digital medicine. I will also greatly benefit from my mentoring team providing me with planned tutorials: 1) Dr. Stafford (primary mentor) on clinician prescribing patterns and education, epidemiological analyses, chronic disease management trials, conduct of responsible research, development and implementation of an integrated research agenda, career networking, and NIH grant writing, 2) Dr. Chertow (co-mentor) on optimal CKD management and the design and management of RCTs for patients with CKD, 3) Dr. Bero (co-mentor) on qualitative methodologies, clinical pharmacology, research synthesis, and translation of evidence into practice, and 4) Dr. Ma (co-mentor) on research with electronic health records, electronic behavioral interventions, and primary care-based trials. To accomplish the research plan, our team will adapt empirically supported content from three related areas of research-on pharmaceutical advertising, social marketing, and enhanced prescriber education. The content will be adapted within an integrated behavioral framework that will synergistically target the dual processing systems of human cognition, the conscious system that involves controlled and purposeful processing and the affective system that uses rapid, automatic processing. The patients we will enroll are those with moderate CKD who receive primary care at Stanford or the Palo Alto Medical Foundation but have not yet adopted indicated medications. During the formative research aim, we will develop the eHealth intervention using observational, systematic review, and qualitative approaches. During the evaluative research aim, we will test the intervention vs. usual care in a 2-arm pilot RCT with 50 patients/arm. The primary outcome will be a 4-point metric assessing control of risk factors for CKD progression (proteinuria, blood pressure, plasma glucose, cholesterol) at 12-month follow-up. The hypothesis is that the eHealth intervention group will achieve better CKD risk factor control than the usual care group. Secondary outcomes will include new prescriptions, CKD progression, and feasibility and process data. Data generated by the development and testing of the eHealth intervention will guide the design of a larger RCT in an R01 application and other related studies. The eHealth intervention has the potential to improve the health of millions of patients with CKD not yet receiving effective medications and to be expanded to related diseases.