This is an application for a K23 Career Development Award for Dr. Lipika Samal, a general internist at Brigham and Women's Hospital (BWH) in Boston, Massachusetts. Dr. Samal is establishing herself as an investigator in health information technology (HIT) to improve outcomes in patients with chronic kidney disease (CKD). Her career goal is to become an independently funded clinician investigator. This K23 award will help her to accomplish the following goals: 1) to obtain advanced training in biostatistics, epidemiology, and HIT research methodology, 2) to improve clinical expertise in management of CKD, 3) to develop and implement an HIT intervention in primary care clinics to improve monitoring, treatment, and referral for patients with CKD, and 4) to develop as an investigator to ensure transition to independent funding status. To achieve these goals, Dr. Samal has chosen a mentoring team committed to her success as a clinician investigator. Her primary mentor is Dr. David Bates, Chief of General Internal Medicine at BWH and an internationally renowned HIT researcher. Her secondary mentors are Dr. Sushrut Waikar, a nephrologist and clinical researcher, and Dr. Jeffrey Linder, a primary care physician and HIT researcher. She will also receive guidance from Dr. Joseph Bonventre, Chief of the Renal Division at BWH and past President of the American Society of Nephrology, as well as Dr. Thomas Sequist, a primary care physician and CKD researcher, biostatistician Dr. John Orav, and epidemiologist Dr. Francis Cook. A large proportion of patients with CKD receive care in primary care clinics, so interventions in the primary care setting are important for delaying progression to end stage renal disease (ESRD). HIT systems can prompt early diagnosis of CKD and can help physicians to stratify patients according to risk of progression to ESRD. Despite this, relatively few studies have been done leveraging HIT in CKD management as compared to other chronic conditions. We propose to develop and evaluate an innovative HIT tool for CKD management in primary care clinics.
Our specific aims are as follows.
Specific Aim 1 : Develop an HIT application to calculate risk of progression to ESRD according to a risk prediction model developed by Tangri, et. al.;
Specific Aim 1 a: Develop a search method to find existing urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate values. Validate the search method through manual chart review;
Specific Aim 1 b: Prepare for implementation of the HIT application by i) designing a user interface after gathering PCP input, ii) conducting usability testing, and iii) convening an interdisciplinary pane to determine a risk threshold for referral within our healthcare system;
Specific Aim 2 : Conduct a cluster randomized trial to determine the effect of the HIT application on the primary outcome: the completion of the necessary tests for the risk prediction model (urine albumin to creatinine ratio, serum calcium, serum phosphate, serum albumin, and serum bicarbonate) for CKD patients in primary care. Secondary outcomes will include nephrology referrals;doubling of serum creatinine;initiation of hemodialysis;and PCP satisfaction. The clinical trial enrollment and data collection will rely on electronic data collected during routine care, a low-cost, feasibl approach to research. The candidate's epidemiology and informatics background, mentorship, and strong environment of informatics resources make these specific aims attainable during the award period. Most patients with CKD are cared for in primary care settings. Early stage management is suboptimal, and this represents a significant public health problem. The most important end result of this study is a proof of concept that a risk prediction model with laboratory results """"""""built-in"""""""" can promote appropriate nephrology referral. The human-centered research in Aim 1 will contribute to a user-friendly HIT tool for this project and will contribute o the literature on primary care HIT interventions. The results from Aim 2 will contribute to preliminary data for an R01 with nephrology referral as the primary outcome. The research performed during the K23 period will inform a subsequent R01 focused on improving additional aspects of CKD management in ambulatory clinics, which is a form of translational research. This information may be useful in future research on improving CKD care in general, and is applicable to other renal diseases including other systemic diseases, inherited diseases, or any form of CKD where monitoring and treatment initially occurs in the primary care setting.

Public Health Relevance

We now know that treating chronic kidney disease in its early stages can prevent dialysis and reduce heart problems that go along with kidney disease. Computerized tools may help primary care doctors to diagnose the disease earlier and computer reminders may help doctors to prescribe the best treatments. In this project we will create computer reminders and we will test them in clinics to see if they improve treatment of early chronic kidney disease.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mentored Patient-Oriented Research Career Development Award (K23)
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Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
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Rankin, Tracy L
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Brigham and Women's Hospital
United States
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Levine, David M; Healey, Michael J; Wright, Adam et al. (2017) Changes in the quality of care during progress from stage 1 to stage 2 of Meaningful Use. J Am Med Inform Assoc 24:394-397
Singh, Karandeep; Waikar, Sushrut S; Samal, Lipika (2017) Evaluating the feasibility of the KDIGO CKD referral recommendations. BMC Nephrol 18:223
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McEvoy, Dustin S; Sittig, Dean F; Hickman, Thu-Trang et al. (2017) Variation in high-priority drug-drug interaction alerts across institutions and electronic health records. J Am Med Inform Assoc 24:331-338
Samal, Lipika; Dykes, Patricia C; Greenberg, Jeffrey O et al. (2016) Care coordination gaps due to lack of interoperability in the United States: a qualitative study and literature review. BMC Health Serv Res 16:143
Samal, Lipika; Wright, Adam; Waikar, Sushrut S et al. (2015) Nephrology co-management versus primary care solo management for early chronic kidney disease: a retrospective cross-sectional analysis. BMC Nephrol 16:162
Dalal, Anuj K; Pesterev, Bailey M; Eibensteiner, Katyuska et al. (2015) Linking acknowledgement to action: closing the loop on non-urgent, clinically significant test results in the electronic health record. J Am Med Inform Assoc 22:905-8
Wright, Adam; Maloney, Francine L; Wien, Matthew et al. (2015) Assessing information system readiness for mitigating malpractice risk through simulation: results of a multi-site study. J Am Med Inform Assoc 22:1020-8
Samal, Lipika; Linder, Jeffrey A; Bates, David W et al. (2014) Electronic problem list documentation of chronic kidney disease and quality of care. BMC Nephrol 15:70

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