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

描述（由申请方提供）：透析前慢性肾脏疾病（CKD）与医疗护理相关伤害的高风险（不良安全性事件）相关。这些事件可能发生在医疗系统范围之外，因此未得到充分认识。卫生信息技术可以加强对此类事件的检测，协调一致的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，以及疾病管理协议（CDC）和安全性特定决策支持，将增加对不良安全事件的检测，从而减少对紧急卫生资源利用的需求和相关的不良结局。研究设计：CKD患者协调护理/家庭远程医疗（CCHT）与常规护理的6个月随机试验。干预措施：退伍军人管理局（VA）CCHT，基于指南的CKD监测，增强的实验室监测和VA肾脏跨学科安全性诊所（RISC）的决策支持。研究人群：患有III-V期CKD（6个月内未预期透析）、年龄60岁和糖尿病的退伍军人（每组n = 65）。研究中心：巴尔的摩退伍军人医学中心（BVAMC）、退伍军人老年医学研究、教育和临床中心（GRECC）和RISC。具体目标1：比较分配至CCHT与常规治疗的CKD患者中不良安全性事件的检测。具体目标2：比较CCHT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：根据CCHT方案获得的生命体征和临床测量值（每日BP、体重和手指针刺血糖）、实验室检查值和患者报告的安全性事件与常规治疗方案中研究中期安全性诊所访视时患者报告的安全性事件、实验室检查值和评估。将测量两组的急诊科（艾德）访视、住院、肾脏进展、ESRD发生率和死亡沿着患者满意度。成果：目标1：各种不良安全性事件的计数，包括低血糖、低血压、容量损失（体重变化）、高钾血症、急性肾损伤（阿基）和患者报告的安全性事件。目标2：艾德访视、住院和其他不良结局，包括肾功能丧失、ESRD和死亡。分析计划：将使用多变量模型比较CCHT组与常规治疗组中目标1和2中跟踪的校正事件发生率（以每月计数表示）。预期结果：CCHT将增加不良安全性事件的检测，但减少紧急卫生资源利用和不良结局。

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.