Patient safety monitoring in kidney disease with an eDiary.

描述(由申请人提供)：肾脏疾病所有阶段的患者都处于与医疗护理相关的高风险伤害中(不良安全事件)。这些事件可能发生在医疗系统之外，而且经常被低估或低估。健康信息技术(HIT)提供了新的方法来跟踪[患者报告的]肾脏疾病的不良安全事件，并向提供者揭示新的数据，这些数据可以导致有益的治疗修改。假设：[交互式语音响应系统(IVRS)通过电话(EDiary)记录患者报告的不良安全事件，并可供大多数肾脏患者使用]，将增加不良安全事件的检测，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电子日记，目的是确定其在检测以前未报告的不良安全事件方面的有效性。2)将向血液透析的终末期肾病(ESRD)患者提供IVRS电子日记的版本，以确定其在检测透析单元外的不良安全事件方面的有效性。[在这两个目标中，通过纸质安全日记和IVRS电子日记记录的患者报告的安全事件将被比较，并以定期报告的形式提交给主要提供者，以评估这一新信息对临床护理的影响]。设备(干预)：[适合目标人群的IVRS平台(CarePlan Manager TM)]。研究设计：交叉设计，比较纸质症状日记和IVRS电子日记。研究人群：1)安全肾脏护理(SKC)队列研究(R01DK084017)中的CKD患者(n=50)，以及2)在巴尔的摩独立透析基金会(IDF)透析机构接受血液透析的终末期肾病患者(n=50)。研究测量：SKC专家共识小组批准的已建立的特定疾病(CKD)不良安全事件(CKD-PSI)，增加了与ESRD相关的安全事件[以及任何额外的自由文本或基于语音的患者报告的安全事件]。结果：通过纸质日记与IVRS电子日记记录的不良安全事件计数将被归类为单独的安全类别，并作为综合处理。[还将确定供应商对安全报告的明确答复]。分析计划：每个子组(CKD和ESRD)内和合并队列中使用Gee Poisson回归将调整后的事件比率表示为每月计数，将其与电子日记中的记录进行比较。[提供者对安全报告的回应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：向精通各种技术的肾病患者推出一本电子日记，旨在发现医疗保健系统边界以外的潜在有害患者安全事件，将提供新的机会来改善这种疾病特有的护理和预后。

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.