Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease

初级保健电子健康干预可改善慢性肾脏病的预后

基本信息

批准号：
9064839
负责人：
Veronica Yank
金额：
$ 15.34万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-01 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9064839
关键词：
Adopted Adoption Adult Advertisements Advertising Affect Affective American Area Behavior Behavior Therapy Behavioral Biometry Blood Pressure Cellular Phone Cholesterol Chronic Disease Chronic Kidney Failure Clinical Pharmacology Clinical Trials Cognition Conscious Data Development Disease Disease Management Disease Progression Dose Education Electronic Health Record Electronics Enrollment Epidemiology Evaluation Foundations Glucose Goals Grant Health Health Knowledge, Attitudes, Practice Health behavior change Healthcare Human Human Resources Individual Intention Intervention Laboratories Marketing Medical Medicine Mentors Meta-Analysis Methodology Motivation Non-Insulin-Dependent Diabetes Mellitus Operating System Outcome Output Patient Care Patients Pattern Pharmaceutical Preparations Pharmacologic Substance Physicians Plasma Population Primary Health Care Process Proteinuria Psychological Techniques Randomized Randomized Controlled Trials Research Risk Factors Sales Science Secure Social Marketing Social Psychology Staging System Testing Text Training Translational Research Translations Uncertainty Unconscious State United States National Institutes of Health Validation Work Writing arm base behavior change behavioral health intervention career career networking computerized data processing design digital disorder risk eHealth efficacy testing efficacy trial follow-up group intervention health care service organization improved improved outcome patient oriented patient population primary care setting primary outcome racial minority research and development secondary outcome skills social systematic review theories treatment as usual

项目摘要

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.

描述（由申请人提供）：我的职业目标是从事转化研究职业，改善在初级保健机构接受治疗的慢性肾病 (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，然后在试点随机对照试验（RCT）中进行测试，旨在改变患者和临床医生的行为。干预措施将包括多成分、多渠道（电子邮件、短信、在线视频）材料，旨在促进有效药物的采用。为了实现这些目标，我将参加课程来扩展我的技能——生物统计学、临床试验、荟萃分析、人类动机、营销技术、心理干预、产品设计和数字医学。我也将受益匪浅我的指导团队为我提供了计划的教程：1）斯塔福德博士（主要导师）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、负责任的研究的进行、综合研究议程的制定和实施、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 患者随机对照试验的设计和管理，3) Bero 博士（共同导师）关于定性方法、临床药理学、研究综合和证据转化为实践，以及 4）马博士（共同导师）关于电子健康记录、电子行为干预和初级保健试验的研究。为了完成研究计划，我们的团队将改编来自药品广告、社会营销和加强处方者教育三个相关研究领域的实证支持内容。内容将在一个综合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，即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，但尚未采用指定药物。在形成性研究目标期间，我们将使用观察、系统评价和定性方法开发电子健康干预措施。在评估研究目标期间，我们将在每组 50 名患者的 2 组试点随机对照试验中测试干预与常规护理。主要结果将是评估 12 个月随访时 CKD 进展危险因素（蛋白尿、血压、血糖、胆固醇）控制情况的 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 危险因素控制。次要结果将包括新处方、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生成的数据将指导 R01 应用程序和其他相关研究中更大型随机对照试验的设计。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，并扩展到相关疾病。