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，但未得到充分认识，在医疗保健系统中，提高患者安全是重中之重。CKD的疾病识别能力差和其他几个特点使其成为不良安全事件的高风险条件。这些不良安全事件可能包括那些通常在一般人群中引用的事件，但也包括特定疾病的不安全操作和错误，这反过来又可能导致不良的疾病终点。假设：旨在提高CKD认可度的干预措施（结构性措施）将通过减少不安全医疗操作和错误的频率（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措施（CKD- psi），然后在CKD验证队列中测量它们，这将被纵向跟踪]。2)[我们将在CKD患者的试点研究中评估一项旨在提高CKD认知度的干预措施]。干预措施：一个警报系统，包括一个CKD医学警报手镯（或项链），带有一个基于网络的信息链接，描述肾脏疾病患者的安全护理。研究设计：a)基于共识的过程，旨在建立一套与疾病特异性患者安全相关的CKD- psi， [b) CKD患者队列研究，以验证CKD- psi的使用，c) CKD患者的试点研究，通过纵向随访确定警报系统的接受程度和影响，以确定干预对CKD- psi发生率的有效性的初步证据。研究人群：来自两个相关医院的单一中心的III - V期透析前CKD患者[验证队列研究：n = 250，试点研究= 100]。研究测量：[验证队列和试点样本]的参与者将接受基线和年度中心随访，以进行病史和药物回顾、肾功能测量（用于估计GFR的血清Cr）、随访电话（两次随访之间每4个月一次），以了解医疗事件，并回顾住院情况（预计持续时间：每年随访1至3次）。[试点研究参与者将在1年内接受重大事件调查。结果：a) [ckd - psi（过程测量）预期]包括用药错误（例如，非甾体抗炎药、剂量不当的药物）、有毒暴露（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和死亡在内的结局指标；c)[接受医疗警报干预]。预期结果：认可的ckd - psi将以显著的基线率进行测量和检测。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，警报干预将具有良好的耐受性，并显示出对CKD患者护理安全性的积极影响。这项研究的结果将有助于开展一项随机对照试验，测试提高疾病认知度是否会通过提高患者安全性来减少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].