Patient safety monitoring in kidney disease with an eDiary.

描述（由申请人提供）：所有阶段的肾脏疾病患者均处于与医疗护理相关的伤害（不良安全性事件）的高风险中。这些事件可能发生在医疗系统之外，并且经常被低估或低估。健康信息技术（HIT）提供了新的手段来跟踪[患者报告的]肾脏疾病不良安全事件，并向提供者揭示新的数据，这些数据可以导致有益的治疗调整。假设：[通过电话（eDiary）记录患者报告的不良安全性事件的交互式语音应答系统（IVRS），可供大多数肾脏病患者使用]将增加不良安全性事件的检测，并[对临床管理产生积极影响]。具体目标：1）将向透析前慢性肾病（CKD）患者提供IVRS电子日志，旨在确定其在检测先前报告不足的不良安全性事件方面的有效性。2)将向接受血液透析的终末期肾病（ESRD）患者提供IVRS电子日志版本，以确定其在检测透析室外不良安全性事件方面的有效性。[In这两个目的都是比较通过纸质安全日志和IVRS电子日志记录的患者报告的安全性事件，并在定期报告中向主要提供者提供，以评估该新信息对临床护理的影响]。器械（介入）：[适用于目标人群的IVRS平台（CarePlan ManagerTM）]。研究设计：交叉设计，比较纸质症状日记与IVRS eDiary。研究人群：1）安全肾脏护理（SKC）队列研究（R 01 DK 084017）中的CKD患者（n=50），和2）在巴尔的摩的独立透析基金会（IDF）透析机构接受血液透析的ESRD患者（n =50）。研究测量：SKC专家共识小组认可的已确定疾病特异性（CKD）不良安全性事件（CKD-PSI），并添加ESRD相关安全性事件[沿着任何其他基于自由文本或语音的患者报告的安全性事件]。成果：通过纸质日志与IVRS电子日志记录的不良安全性事件计数将被分类为单个安全性类别，并作为复合事件处理。[还将确定供应商对安全报告的明确答复]。分析计划：在每个亚组（CKD和ESRD）和合并队列中，将使用GEE Poisson回归比较论文与电子日志中记录的校正后事件发生率（表示为每月计数）。[提供者对安全性报告的答复将在参与者层面进行统计，并在日记组之间进行比较。]相关性：一个电子日记介绍给肾病患者广泛的熟练程度与技术，旨在检测潜在的有害患者安全事件超出了医疗保健系统的边界，将提供新的机会，以改善护理和结果的特点，这种疾病。

DESCRIPTION (provided by applicant): Patients with all stages of kidney disease are at a high risk of harm related to medical care (adverse safety events). These events may occur outside of the medical system and are often under-reported or under- appreciated. Health information technology (HIT) offers novel means to track [patient-reported] adverse safety events in kidney disease, and reveal new data to providers that can lead to beneficial treatment modifications. Hypothesis: An [interactive voice response system (IVRS) that records patient-reported adverse safety events via telephone (eDiary), and is useable by a majority of kidney patients], will increase the detection of adverse safety events and [have a positive impact on clinical management]. Specific aims: 1) An IVRS eDiary will be offered to patients with pre-dialysis chronic kidney disease (CKD) with the intent of determining its effectiveness in detecting previously under-reported adverse safety events. 2) A version of the IVRS eDiary will be provided to patients with end-stage renal disease (ESRD) on hemodialysis to determine its effectiveness in detecting adverse safety events outside the dialysis unit. [In both aims the patient-reported safety events recorded via paper safety diary and the IVRS eDiary will be compared and presented in regular reports to primary providers to assess the impact of this new information on clinical care]. Device (intervention): [an IVRS platform (CarePlan ManagerTM) adapted for the target population]. Study design: a cross-over design comparing a paper-based symptom diary to the IVRS eDiary. Study population: 1) CKD patients (n=50) in the Safe Kidney Care (SKC) cohort study (R01DK084017), and 2) ESRD patients (n =50) who receive hemodialysis at Independent Dialysis Foundation (IDF) dialysis facilities in Baltimore. Study Measurements: established disease-specific (CKD) adverse safety incidents (CKD-PSI) endorsed by the SKC expert consensus panel with the addition of ESRD-pertinent safety events [along with any additional free-text or voice-based patient-reported safety events]. Outcomes: Counts of adverse safety events recorded via paper diary versus IVRS eDiary will be classified in individual safety categories and also treated as a composite. [Providers' categorical responses to safety reports will also be ascertained]. Analytic plans: Adjusted rates of events expressed as counts per month will be compared as recorded in the paper vs eDiary using GEE Poisson regression within each sub-group (CKD and ESRD) and as a combined cohort. [Provider responses to safety reports will be tallied at the participant-level and compared across diary groups.] Relevance: An eDiary introduced to kidney disease patients with a wide range in proficiency with technology, and designed to detect potentially harmful patient safety incidents beyond the boundaries of the health care system, will offer new opportunities to improve care and outcomes characteristic of this disease.