Kidney Awareness Registry and Education-2

 描述（由申请人提供）：增强CKD健康：肾脏意识登记和教育-2（KARE-2）试验摘要慢性肾脏疾病（CKD）是常见的，导致过度的死亡率和发病率，并与患病率和临床结局方面的社会人口统计学差异相关。糖尿病患者的血糖控制、血压控制以及使用血管紧张素转换酶抑制剂（ACEi）或血管紧张素受体阻滞剂（ARB）减少蛋白尿等措施有助于延缓CKD下降并降低CKD相关的发病率和死亡率;然而，许多CKD患者并未从这些科学进步中获益。这种翻译的缺乏可能部分是由于提供者和患者对CKD的认识水平非常低，导致初级保健提供者对提供CKD护理的自我效能不足，以及患者参与健康生活方式和坚持药物治疗方案的参与度差。为了满足这一需求，我们的多学科团队开发并试行了两种干预措施，以提高医疗服务提供者和患者的认识，并将这些知识转化为更优化的CKD护理。提供者干预是为整个医疗保健团队量身定制的CKD登记研究，提供有关CKD管理的床旁决策支持和CKD相关临床数据的床外总结，以通过外展和人群健康优化符合指南的CKD护理。患者干预是一个全面的自我管理支持计划，包括低识字教育材料，语言/文化定制的自动电话， 自我管理支持（CKD-ATSM）、健康指导和提醒短信。我们的团队在一个为低收入、多语言人群服务的学术诊所的试点可行性研究（NCT 01530958）中成功地试点了这两种干预措施。此后，我们改进了干预措施，将登记与电子病历相结合，并将移动的短信纳入自我管理计划。我们现在准备研究的有效性，完善的干预措施对健康的结果在一个大的多样化，低收入人口使用慢性护理模式框架的医疗保健服务。我们提出了一项名为肾脏意识登记和教育-2（KARE-2）的2x2析因随机对照试验，其中我们将在6个联邦合格的社区卫生中心随机分配60名提供者和400名CKD患者，接受提供者干预（CKD登记）或常规护理以及患者自我管理支持干预（CKD-ATSM）或常规护理。我们将评估KARE-2的提供者干预组件（目标1）的影响; KARE-2的患者干预组件（目标2）;以及它们的相互作用（目标3）对患者水平的临床结局（例如，血压，CKD下降）;提供者行为结果（例如，CKD管理的提供者自我效能）;和患者行为结果（例如，CKD意识，参与自我管理行为）。如果一种或两种KARE-2干预措施在改善高危患者的健康方面有效，则可以将其传播到其他交付系统，以改变美国CKD护理的交付方式，从而降低CKD相关的发病率和死亡率。

 DESCRIPTION (provided by applicant): Enhancing CKD health: Kidney Awareness Registry and Education-2 (KARE-2) trial Abstract Chronic kidney disease (CKD) is common, causes excess mortality and morbidity, and is associated with socio-demographic disparities with respect to prevalence and clinical outcomes. Measures such as glycemic control in persons with diabetes, blood pressure control, and reduction of proteinuria with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) can help delay CKD decline and decrease CKD-associated morbidity and mortality; however, many individuals with CKD are not benefiting from these scientific advances. This lack of translation may be due in part to very low levels of CKD awareness among providers and patients leading to inadequate primary care provider self-efficacy for delivery of CKD care and poor patient engagement to participate in healthy lifestyles and adhere to medication regimens. To address this need, our multi-disciplinary team has developed and piloted two interventions that increasing awareness among providers and patients and translate that knowledge into more optimal CKD care. The provider intervention is a CKD registry tailored to the entire healthcare team that provides point-of-care decision support regarding CKD management and outside-of care summaries of CKD relevant clinical data to optimize delivery of guideline-concordant CKD care via outreach and population health. The patient intervention is a comprehensive self-management support program that includes low-literacy educational materials, linguistically/culturally tailored automated telephone self-management support (CKD-ATSM), health coaching, and reminder text messages. Our team has successfully piloted both interventions in a pilot feasibility study (NCT01530958) in one academic clinic that serves a low-income, multilingual population. We have since refined the interventions to integrate the registry with the electronic medical record and to include mobile texting in the self-management program. We are now poised to study the effectiveness of the refined interventions on health outcomes among a large diverse, low-income population using the Chronic Care Model framework of health care delivery. We propose a 2x2 factorial randomized controlled trial entitled Kidney Awareness Registry and Education-2 (KARE-2), in which we will randomize 60 providers and 400 patients with CKD in 6 federally qualified community health centers to receive the provider intervention (CKD registry) or usual care and the patient self- management support intervention (CKD-ATSM) or usual care. We will assess the impact of the provider intervention component of KARE-2 (Aim 1); the patient intervention component of KARE-2 (Aim 2); and their interaction (Aim 3) on patient-level clinical outcomes (e.g., blood pressure, CKD decline); provider behavioral outcomes (e.g., provider self-efficacy for CKD management); and patient behavioral outcomes (e.g., CKD awareness, participation in self-management behavior). If one or both KARE-2 interventions are effective at improving health among high-risk patients, they can be disseminated to other delivery systems to change the way CKD care is delivered in the US, leading to reductions in CKD-associated morbidity and mortality.