Does underrecognition of kidney disease affect patient safety?

描述（由申请人提供）：慢性肾脏疾病（CKD）在医疗保健系统中很常见，但认识不足，在医疗保健系统中，提高患者安全性是一个高度优先事项。疾病识别不良和CKD的其他几个特征使其成为不良安全性事件的高风险状况。这些不良安全性事件可能包括一般人群中通常引用的事件，但也包括疾病特异性不安全操作和错误，这些操作和错误反过来可能导致不良疾病终点。假设：旨在提高对CKD认识的干预措施（结构性措施）将通过降低不安全医疗实践和错误的频率（过程措施）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异性过程测量（CKD-PSI），然后在CKD验证队列中对其进行测量，该队列将进行纵向跟踪。2)[我们将在CKD患者的试点研究中评估旨在提高CKD识别率的干预措施]。干预措施：警报系统由CKD医疗警报手镯（或项链）组成，带有基于网络的信息链接，描述肾病患者的安全护理。研究设计：a）旨在建立一组与疾病特异性患者安全性相关的CKD-PSI的基于共识的过程，[B）CKD患者队列研究，以验证CKD-PSI的使用，c）CKD患者试点研究，以确定警报系统的接受程度和影响，并进行纵向随访，以确定干预措施对CKD-PSI发生率有效性的初步证据。研究人群：III-V期、透析前CKD患者入组自一家中心和两家相关医院[验证队列研究：n = 250，初步研究= 100]。研究测量：受试者[验证队列和初步样本]将接受基线和年度中心内访视，以进行病史和药物审查、肾功能测量（用于估计GFR的血清Cr）、医疗事件的随访电话[访视之间每4个月一次]和住院审查（预期持续时间：1 - 3次年度随访访视）。[初步研究受试者将在1年时接受严重事件调查。]结局：a）[CKD-PSI（过程测量）预期]包括用药错误（例如，非甾体抗炎药，用药不当），毒性暴露（例如，造影剂等），和医疗事件（例如，高钾血症或低血糖症等）; B）结局指标，包括肾功能变化、住院、ESRD和死亡也将被跟踪; c）[接受Med-alert干预]。预期结果：将以显著的基线率可行地测量和检测认可的CKD-PSI。这些CKD-PSI将显示与后续不良肾脏结局相关的证据。随着时间的推移，警报干预将具有良好的耐受性，并表明对慢性肾病患者的护理安全产生积极影响。这项研究的结果将有助于开发一项随机对照试验，以测试增加疾病识别是否会通过改善患者安全性来减少CKD的不良疾病结局]。

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].