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.

Public Health Relevance

This project seeks to improve the health of patients with chronic kidney disease (CKD) by developing and testing an electronic health intervention (that will combine secure e-mail, smartphone text message, and online video materials) to promote patient use of effective medications. The information we collect on the electronic health intervention will guide future research, including a larger trial and other studies among related patient groups (e.g., racial minorities) and diseases (e.g., type 2 diabetes mellitus). The project has the potential to improve health outcomes for the millions of patients with CKD who are not yet receiving effective medications.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23DK097308-02
Application #
8705510
Study Section
Special Emphasis Panel (ZDK1-GRB-G (M2))
Program Officer
Rankin, Tracy L
Project Start
2013-08-01
Project End
2018-05-31
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
2
Fiscal Year
2014
Total Cost
$153,113
Indirect Cost
$11,342
Name
Stanford University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305
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Ma, Jun; Yank, Veronica; Lv, Nan et al. (2015) Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial. Contemp Clin Trials 43:260-78
Rosas, Lisa G; Lv, Nan; Azar, Kristen et al. (2015) Applying the Pragmatic-Explanatory Continuum Indicator Summary Model in a Primary Care-Based Lifestyle Intervention Trial. Am J Prev Med 49:S208-14