Navigating the Challenges of Chronic Kidney Disease

描述(由申请人提供)：我们与该项目相关的长期目标是开发、示范和促进广泛实施对患者和护理提供者的支持方法，以优化慢性肾脏疾病(CKD)患者对最佳可用疾病管理方案的坚持。慢性肾脏病在美国是一个巨大且代价高昂的公共卫生问题，随着人口老龄化和肥胖、高血压和糖尿病发病率的增加，这个问题将继续增长。虽然循证治疗和自我管理方案在减缓慢性肾脏病进展到终末期肾病方面是有效的，但患者和初级保健提供者之间的认识和协调不足阻碍了这些方法的广泛实施。对于这项计划拨款，我们建议进行一项临床试验，以测试两种互动的信息方法，以改善CKD患者的慢性护理和最终结果。这两种方法都将遵循成熟的慢性护理模式，以改善CKD 3b/4期患者的CKD结局。在具体目标1中，我们将采用肿瘤学领域成功应用的个体患者导航器的模型来创建CKD患者导航器计划，以促进对慢性护理方案的遵守。我们假设，CKD患者导航员计划将产生比常规护理更有准备、更积极主动的患者护理人员群体。在具体目标2中，我们将使用我们现有的基于电子健康记录的个人健康记录(PHR)，并对其进行改进，以使用电子通信来传播CKD教育和针对CKD阶段3b/4患者的特定护理目标。我们假设，增强的PHR将导致比常规护理更了解情况、更活跃的患者。在特定目标3中，我们将采用析因设计进行前瞻性随机临床试验，以调查特定目标1和2中描述的两种干预措施对3b期或4期CKD患者的临床影响和成本效益。将从近18,000名3b/4期慢性肾脏病患者中招募208名患者参加试验，这些患者是由我们开发和验证的克利夫兰诊所卫生系统基于电子病历的慢性肾脏病注册中心确定的。我们假设，与仅接受常规护理的患者相比，患者导航臂和增强PHR臂的患者估计肾小球滤过率的下降速度将较慢。这项研究的结果将为一项更大的多中心国家临床试验奠定基础，该试验将建立在从这项规划拨款中获得的可行性和知识的基础上，致力于将有效的干预措施转化为常规临床实践，并最终改善CKD患者的CAR。

DESCRIPTION (provided by applicant): Our long term objective related to this project is to develop, demonstrate and promote widespread implementation of support approaches for patients and care providers that optimize chronic kidney disease (CKD) patients' adherence to the best available disease management regimen. CKD is a large and costly public health problem in the U.S. that will continue to grow with the aging of the population and increasing incidences of obesity, hypertension and diabetes. Although evidence-based treatments and self-management regimens are available that are effective in slowing progression of CKD to end-stage renal disease, inadequate awareness and coordination among patients and primary care providers has prevented widespread implementation of those approaches. For this planning grant, we propose to conduct a clinical trial to test two interactive informational approaches to improving chronic care and ultimately outcomes of CKD patients. Both approaches will follow the well-established chronic care model to improve CKD outcomes for CKD Stage 3b/4 patients. In Specific Aim 1, we will adapt the model of individual patient navigators employed successfully in the oncology field to create a CKD Patient Navigator program to promote adherence to the chronic care regimen. We hypothesize that a CKD Patient Navigator program will produce a more prepared, proactive patient-caregiver group than usual care. In Specific Aim 2, we will work with our existing electronic health record-based personal health record (PHR) and enhance it to use electronic communication to disseminate CKD education and stage-specific goals of care for CKD Stage 3b/4 patients. We hypothesize that an enhanced PHR will result in a more informed, activated patient than usual care. In Specific Aim 3, we will conduct a prospective randomized clinical trial using a factorial design to investigate the clinical impact and cost-effectiveness of the two interventions described in Specific Aims 1 and 2 for patients with stage 3b or stage 4 CKD. Two hundred and eight patients will be recruited for the trial from among nearly 18,000 patients with stage 3b/4 CKD identified in the Cleveland Clinic Health Systems EHR-based CKD Registry developed and validated by us. We hypothesize that patients in the patient navigator arm and those in the enhanced PHR arm will have a slower rate of decline in estimated glomerular filtration rate than patients receiving only usual care. The results of this study will lay the foundation for a larger multi-center national clinical trial tha will build upon the feasibility and knowledge gained from this planning grant to work towards translating effective interventions into routine clinical practice and ultimately improving the car of those with CKD.