Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease

描述(由申请者提供)：我的职业目标是从事翻译研究职业，改善对在初级保健环境中接受治疗的慢性肾脏疾病(CKD)患者的护理。我想开发一种基于理论的电子健康(EHealth)干预措施，并在试点随机对照试验(RCT)中进行测试，目的是改变患者和临床医生的行为。干预措施将由多成分、多渠道(电子邮件、短信、在线视频)材料组成，旨在促进有效药物的采用。为了实现这些目标，我将参加课程以扩大我的技能集-那些关于生物统计学、临床试验、荟萃分析、人类动机、营销技巧、心理干预、产品设计和数字医学的课程。我也将从中受益匪浅 我的指导团队为我提供了计划中的教程：1)斯塔福德博士(首席导师)，关于临床医生处方模式和教育，流行病学分析，慢性病管理试验，进行负责任的研究，开发和实施综合研究议程，职业网络，以及NIH拨款申请，2)Chertow博士(共同导师)，关于CKD患者的最佳CKD管理和RCT的设计和管理，3)Bero博士(共同导师)，关于定性方法，临床药理学，研究综合，以及将证据转化为实践，4)Ma博士(联合导师)，关于电子健康记录，电子行为干预，以及基于初级保健的试验。为了完成研究计划，我们的团队将采用来自三个相关研究领域的经验性支持的内容-药品广告、社交营销和加强处方者教育。内容将在一个综合的行为框架内进行调整，该框架将协同瞄准人类认知的双重处理系统，涉及受控和有目的的处理的意识系统，以及使用快速、自动处理的情感系统。我们将纳入的患者是那些患有中度CKD的患者，他们在斯坦福大学或帕洛阿尔托医学基金会接受初级护理，但尚未采用适应症药物。在形成性研究目标中，我们将采用观察性的、系统的回顾和定性的方法来发展电子健康干预。在评估研究目标期间，我们将在50名患者/组的双臂试验性随机对照试验中测试干预和常规护理。主要结果将是在12个月的随访中评估对CKD进展的危险因素(蛋白尿、血压、血糖、胆固醇)的控制的4分指标。假设电子健康干预组将实现比常规护理组更好的CKD危险因素控制。次要结果将包括新的处方、CKD进展以及可行性和过程数据。电子健康干预的开发和测试产生的数据将指导在R01应用程序和其他相关研究中设计更大的随机对照试验。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慢性肾脏病患者的健康，并有可能扩大到相关疾病。

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.