Does underrecognition of kidney disease affect patient safety?

描述(由申请人提供)：慢性肾脏疾病(CKD)在卫生保健系统中很常见，但没有得到足够的认识，在卫生保健系统中，提高患者安全是高度优先的。疾病识别能力差和CKD的其他几个特征使其成为不良安全事件的高危条件。这些不良安全事件可能包括普通人群经常提到的事件，但也包括疾病特有的不安全做法和错误，这反过来可能导致不利的疾病终点。假设：旨在提高对CKD(一种结构性措施)的认可度的干预措施将通过减少不安全的医疗实践和错误(过程措施)的频率来减少不良事件(结果措施)。总体目标：1)我们将建立反映CKD患者安全性的疾病特定流程措施(CKD-PSI)，然后在CKD验证队列中对它们进行测量，并将进行纵向跟踪]。2)[我们将在CKD患者的初步研究中评估旨在提高对CKD的认识的干预措施]。干预：由CKD医疗警报手镯(或项链)和基于网络的信息链接组成的警报系统，描述了肾脏疾病患者的安全护理。研究设计：a)一项基于共识的过程，旨在建立一套与特定疾病患者安全相关的CKD-PSI，[b)对CKD患者进行队列研究，以验证CKD-PSI的使用，c)对CKD患者进行试点研究，以确定警报系统的接受度和影响，并进行纵向跟踪，以确定干预措施对CKD-PSI发病率有效的初步证据。研究人群：从两家相关医院的单一中心登记的III-V期透析前慢性肾脏病患者[验证队列研究：N=250，先导性研究=100]。研究测量：参与者[在验证队列和试点样本中]将接受基线和年度中心就诊，以了解病史和用药审查，测量肾功能(用于估计GFR的血清肌酐)，就医疗事件[每隔4个月]进行跟踪电话，并审查住院情况(预计持续时间：每年1至3次)。[试点研究参与者将在1年内接受关键事件调查。]结果：a)[CKD-PSI(过程测量)预计]包括用药错误(例如非甾体抗炎药、不当用药)、中毒暴露(例如造影剂等)和医疗事件(例如高钾血症或低血糖等)；b)还将跟踪包括肾功能变化、住院、ESRD和死亡在内的结果测量；c)[接受MED-ALERT干预]。预期结果：认可的CKD-PSI将被可行地测量，并以显著的基线比率被检测到。这些CKD-PSI将显示与随后的不良肾脏结局相关的证据。随着时间的推移，警报干预将被很好地耐受，并显示出对慢性肾脏病患者的护理安全产生积极影响的迹象。这项研究的发现将有助于开发一项随机对照试验，测试疾病认知度的提高是否会通过改善患者安全性来减少慢性肾脏病的不良疾病结果]。 公共卫生相关性：慢性肾脏疾病(CKD)很常见，在使用医疗保健系统的患者中经常得不到承认，在那里，改善患者安全已成为高度优先事项。我们将验证使用特定于CKD的患者安全指标，并试点使用Medi-Alert手镯和项链，以提高对CKD的认知度，并评估其在减少CKD特定安全事件频率方面的有效性。

DESCRIPTION (provided by applicant): Chronic kidney disease (CKD) is common, but under-recognized, in the health care system, where improving patient safety is a high priority. Poor disease recognition and several other features of CKD make it a high risk condition for adverse safety events. These adverse safety events may include those usually cited for the general population, but also, disease-specific unsafe practices and errors, which in turn, can lead to adverse disease endpoints. Hypothesis: an intervention designed to increase recognition of CKD (a structural measure) will reduce adverse events (outcome measures) by a decrease in the frequency of unsafe medical practices and errors (process measures). Overall aims: 1) We will establish disease-specific process measures reflecting patient safety in CKD (CKD-PSIs) and then measure them in a CKD validation cohort, which will be tracked longitudinally]. 2) [We will evaluate an intervention designed to improve recognition of CKD in a pilot study of CKD patients]. Intervention: An alert system comprised of a CKD med-alert bracelet (or necklace) with a web-based informational link describing the safe care of patients with kidney disease. Study design: a) A consensus-based process intended to establish a set of CKD-PSI linked to disease- specific patient safety, [b) a cohort study of persons with CKD to validate the use of the CKD-PSIs, c) a pilot study of persons with CKD to determine the acceptance and impact of the alert system with longitudinal follow- up to identify preliminary evidence of the efficacy of the intervention on the incidence of CKD-PSIs . Study population: Persons with Stage III - V, pre-dialysis CKD enrolled from a single center with two associated hospitals [validation cohort study: n = 250, pilot study = 100]. Study Measurements: Participants [in both the validation cohort and pilot sample] will undergo baseline and annual in-center visits for medical history and medication review, measurement of renal function (serum Cr for estimation of GFR), follow-up telephone calls [every 4 months between visits] for medical events, and review of hospitalizations (expected duration: from 1 to 3 annual follow-up visits). [Pilot study participants will undergo critical incident surveys at 1 year.] Outcomes: a) [CKD-PSIs (process measures) expected to] include medication errors (e.g., NSAIDs, improperly dosed meds), toxic exposures (e.g., contrast agents, etc), and medical events (e.g., hyperkalemia or hypoglycemia, etc); b) outcome measures including changing renal function, hospitalization, ESRD, and death will also be tracked; c) [acceptance of Med-alert intervention] . Expected findings: Endorsed CKD-PSIs will be feasibly measured and detectable at a significant baseline rate. These CKD-PSIs will show evidence of association with subsequent adverse renal outcomes. The alert intervention will be well tolerated over time and demonstrate indications of a positive impact on the safety of care of patients with CKD. The findings from this study will be instrumental to the development of a randomized controlled trial testing whether increased disease recognition will reduce adverse disease outcomes in CKD via improved patient safety]. PUBLIC HEALTH RELEVANCE: Chronic kidney disease (CKD) is common, and often goes unrecognized among patients using the health care system where improving patient safety has become a high priority. We will validate the use CKD-specific patient safety indicators and pilot the use of a Medi-alert bracelet and necklace to increase the recognition of CKD, and evaluate its efficacy in reducing the frequency of CKD-specific safety events.