Care Coordination/Telehealth to address patient safety and poor outcomes in CKD

描述(由申请人提供)：透析前慢性肾脏疾病(CKD)与与医疗相关的高风险伤害(不良安全事件)相关。这些事件可能发生在医疗系统的权限之外，因此没有得到足够的认识。卫生信息技术(IT)可以加强对这类事件的检测，协调护理可以防止其不良后果。假设：CKD患者的家庭远程健康监测具有疾病管理协议(DMP)和特定于安全的决策支持，将增加对不良安全事件的检测，进而减少对紧急卫生资源利用和相关不良结果的需求。研究设计：对CKD患者进行为期6个月的协同护理/家庭远程保健(CCHT)与常规护理的随机试验。干预：退伍军人管理局(VA)CCHT，基于指南的CKD DMP，增强的实验室监测，以及来自VA肾脏跨学科安全诊所(RISC)的决策支持。研究人群：患有III-V期CKD的退伍军人(6个月内没有预期的透析)，年龄e 60岁，糖尿病(每臂65例)。研究地点：巴尔的摩退伍军人医学中心(BVAMC)、退伍军人事务部老年病研究、教育和临床中心(GRECC)和RISC。具体目标1：比较接受CCHT治疗的CKD患者与常规治疗的CKD患者不良安全事件的检测。具体目标2：比较CCHT组与常规护理组的紧急卫生服务使用频率和参与者满意度。研究测量：生命体征和临床测量(每日血压、体重和手指血糖)、化验值和根据CCHT方案获得的患者报告的安全事件与患者报告的安全事件、实验室值和在通常护理方案中进行研究中期安全诊所访问时的评估。两组患者的急诊科就诊、住院、肾脏进展、终末期肾病的发生率和死亡率将与患者满意度一起被测量。结果：目标1：计数各种不良反应事件，包括低血糖、低血压、容量减少(通过体重变化)、高钾血症、急性肾损伤(AKI)和患者报告的安全事件。目的2：急诊室就诊、住院和其他不良结果，包括肾功能丧失、终末期肾病和死亡。分析计划：在目标1和目标2中跟踪的事件的调整比率，并以每月计数的形式表示，将在CCHT组与常规护理组进行比较，并使用所示的多变量模型。预期结果：CCHT将增加不良安全事件的检测，但减少紧急卫生资源的利用和不良后果。

DESCRIPTION (provided by applicant): Pre-dialysis chronic kidney disease (CKD) is associated with a high risk of harm related to medical care (adverse safety events). These events may occur outside the purview of the medical system, and hence, are under-recognized. Health information technology (IT) can enhance the detection of such events, and coordinated care can prevent their adverse consequences. Hypothesis: Home telehealth monitoring of CKD patients, with a disease management protocol (DMP) and safety-specific decision support, will increase the detection of adverse safety events, and in turn, reduce the need for urgent health resource utilization and associated poor outcomes. Study design: 6-month randomized trial of coordinated care/home telehealth (CCHT) vs. usual care in CKD patients. Intervention: Veterans Administration (VA) CCHT with a guideline- based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter- disciplinary Safety clinic (RISC). Study population: Veterans with Stage III-V CKD (no expected dialysis within 6 months), age e 60 years old, and diabetes (n = 65 per arm). Study Site: Baltimore VA Medical Center (BVAMC), VA Geriatrics Research, Education and Clinical Center (GRECC), and RISC. Specific Aim 1: Compare detection of adverse safety events in CKD patients assigned to CCHT vs. usual care. Specific Aim 2: Compare the frequency of urgent health service use and participant satisfaction with CCHT vs. usual care group. Study Measurements: Vital sign and clinical measurements (daily BP, weight, and finger stick glucose), laboratory values, and patient- reported safety events obtained per CCHT protocol vs. patient-reported safety events, laboratory values, and assessment at a mid-study safety clinic visit in usual care protocol. Emergency department (ED) visits, hospitalization, renal progression, incidence of ESRD, and death will be measured in both groups along with patient satisfaction. Outcomes: Aim 1: Counts of a diverse set of adverse safety events including hypoglycemia, hypotension, volume loss (by weight change), hyperkalemia, acute kidney injury (AKI), and patient-reported safety incidents. Aim 2: ED visits, hospitalization, and other adverse outcomes including renal function loss, ESRD, and death. Analytic plans: Adjusted rates of events tracked in Aim 1 and 2 and expressed as counts per month will be compared in CCHT vs. usual care group with multivariate models as indicated. Expected findings: CCHT will increase the detection of adverse safety events but reduce urgent health resource utilization and adverse outcomes.