Health Information Technology for Chronic Kidney Disease Management

描述(由申请人提供)：这是马萨诸塞州波士顿布里格姆妇女医院(BWH)的普通内科医生Lipika Samal博士的K23职业发展奖的申请。萨马尔博士正在确立自己在健康信息技术(HIT)领域的研究地位，以改善慢性肾脏疾病(CKD)患者的预后。她的职业目标是成为一名独立资助的临床医生研究员。这一K23奖项将帮助她实现以下目标：1)获得生物统计学、流行病学和HIT研究方法方面的高级培训，2)提高CKD管理的临床专业知识，3)在初级保健诊所开发和实施HIT干预措施，以改善对CKD患者的监测、治疗和转介，以及4)发展成为一名研究人员，以确保过渡到独立的资助状态。为了实现这些目标，萨马尔博士选择了一个指导团队，致力于让她作为一名临床医生研究员取得成功。她的主要导师是BWH普通内科主任、国际知名的HIT研究员David Bates博士。她的二级导师是肾病学家和临床研究员Sushrut Waikar博士，以及初级保健医生和HIT研究员Jeffrey Linder博士。她还将接受BWH肾科主任、美国肾脏学会前主席Joseph Bonventre博士以及初级保健医生兼CKD研究员Thomas Sequist博士、生物统计学家John Orav博士和流行病学家Francis Cook博士的指导。很大比例的CKD患者在初级保健诊所接受护理，因此初级保健环境中的干预对于延缓进展为终末期肾病(ESRD)非常重要。HIT系统可以提示CKD的早期诊断，并可以帮助医生根据进展为ESRD的风险对患者进行分层。尽管如此，与其他慢性疾病相比，在CKD治疗中利用HIT进行的研究相对较少。我们建议开发和评估一种创新的HIT工具，用于初级保健诊所的CKD管理。我们的具体目标如下。具体目标1：根据Tangri等人开发的风险预测模型，开发HIT应用程序来计算进展到ESRD的风险。具体目标1a：开发一种搜索方法，以找到现有的尿白蛋白/肌酐比、血清钙、血清磷、血清白蛋白和血清碳酸氢值。通过手动图表审查验证搜索方法；具体目标1b：通过i)收集PCP输入后设计用户界面，ii)进行可用性测试，以及iii)召集跨学科小组来确定我们医疗系统内转诊的风险阈值，为HIT应用的实施做准备；具体目标2：进行整群随机试验，以确定HIT应用对主要结果的影响：完成对初级保健中的CKD患者的风险预测模型(尿白蛋白/肌酐比率、血清钙、血清磷、血清白蛋白和血清碳酸氢盐)的必要测试。次要结果将包括肾病转诊；血肌酐增加一倍；开始血液透析；以及PCP满意度。临床试验登记和数据收集将依赖于在常规护理期间收集的电子数据，这是一种低成本、可行的研究方法。候选人的流行病学和信息学背景、导师和强大的信息学资源环境使这些具体目标在获奖期间可以实现。大多数慢性肾脏病患者在初级保健环境中得到护理。早期管理是次优的，这是一个重大的公共卫生问题。这项研究最重要的最终结果是一个概念的证明，即具有实验室结果的风险预测模型可以促进适当的肾脏转诊。AIM 1中的以人为中心的研究将有助于为该项目提供一个用户友好的HIT工具，并将有助于初级保健HIT干预的文献。AIM 2的结果将有助于以肾脏病转诊为主要结果的R01的初步数据。在K23期间进行的研究将为随后的R01提供信息，该R01专注于改善门诊诊所CKD管理的其他方面，这是一种转换研究形式。这些信息可能对今后总体上改善慢性肾脏病护理的研究有用，并适用于其他肾脏疾病，包括其他系统性疾病、遗传性疾病或最初在初级保健环境中进行监测和治疗的任何形式的慢性肾脏病。

DESCRIPTION (provided by applicant): 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 1a: 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 1b: 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.