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

护理协调/远程医疗可解决 CKD 患者的安全和不良预后问题

• 批准号: 8856231
• 负责人: JEFFREY C FINK
• 金额: $ 28.35万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8856231
• 关键词: Accident and Emergency department; Acute Renal Failure with Renal Papillary Necrosis; Address; Age-Months; Attention; Baltimore; Blood Pressure; Body Weight Changes; Caring; Cessation of life; Characteristics; Chronic Disease; Chronic Kidney Failure; Client satisfaction; Clinic; Clinic Visits; Clinical; Data; Detection; Diabetes Mellitus; Dialysis procedure; Disease; Disease Management; Education; Emergency Care; Emergency department visit; End stage renal failure; Event; Fingers; Frequencies; Geriatrics; Glucose; Goals; Grant; Guidelines; Health; Health Resources; Health Services; Health system; Healthcare; Healthcare Systems; Hemorrhage; Home environment; Hospitalization; Hypoglycemia; Hypotension; Incidence; Intervention; Kidney; Kidney Diseases; Laboratories; Measurement; Measures; Medical; Medical center; Modeling; Monitor; Outcome; Participant; Patients; Pharmaceutical Preparations; Population Study; Prevention; Protocols documentation; Provider; Reaction; Reading; Renal function; Reporting; Research; Research Design; Safety; Site; Staging; Symptoms; System; Translating; United States Department of Veterans Affairs; Veterans; Weight; adverse outcome; arm; base; chronic care model; clinical practice; design; diaries; experience; falls; health information technology; high risk; hyperkalemia; improved; patient home care; patient safety; prevent; programs; randomized trial; response; safety study; satisfaction; service utilization; telehealth; treatment as usual

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.

描述（由申请人提供）：透析前慢性肾脏病 (CKD) 与医疗护理相关的高伤害风险（不良安全事件）相关。这些事件可能发生在医疗系统的范围之外，因此未被充分认识。健康信息技术 (IT) 可以加强对此类事件的检测，协调护理可以防止其不良后果。假设：通过疾病管理方案 (DMP) 和特定于安全的决策支持对 CKD 患者进行家庭远程医疗监测，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：针对 CKD 患者进行协调护理/家庭远程医疗 (CCHT) 与常规护理的为期 6 个月的随机试验。干预：退伍军人管理局 (VA) CCHT 以及基于指南的 CKD DMP、增强实验室监测以及 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（预计 6 个月内不会进行透析）、年龄 60 岁左右、患有糖尿病（每组 n = 65 人）。研究地点：巴尔的摩退伍军人管理局医疗中心 (BVAMC)、退伍军人管理局老年医学研究、教育和临床中心 (GRECC) 和 RISC。具体目标 1：比较接受 CCHT 治疗和常规治疗的 CKD 患者不良安全事件的检测情况。具体目标 2：比较紧急医疗服务使用频率和参与者对 CCHT 与常规护理组的满意度。研究测量：根据 CCHT 方案获得的生命体征和临床测量（每日血压、体重和指尖血糖）、实验室值和患者报告的安全事件与常规护理方案中研究中期安全诊所就诊时患者报告的安全事件、实验室值和评估。将评估两组的急诊科 (ED) 就诊、住院、肾病进展、终末期肾病 (ESRD) 发生率和死亡情况以及患者满意度。结果：目标 1：对各种不良安全事件进行计数，包括低血糖、低血压、容量减少（体重变化）、高钾血症、急性肾损伤 (AKI) 和患者报告的安全事件。目标 2：急诊室就诊、住院治疗和其他不良后果，包括肾功能丧失、ESRD 和死亡。分析计划：目标 1 和 2 中跟踪的事件的调整率并表示为每月计数，将在 CCHT 与常规护理组中与所示的多变量模型进行比较。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。