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Does underrecognition of kidney disease affect patient safety?

对肾脏疾病认识不足是否会影响患者安全？

基本信息

批准号：
8704924
负责人：
JEFFREY C FINK
金额：
$ 43.43万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-01 至 2017-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8704924
关键词：
Accounting Address Adverse event Affect Cessation of life Chronic Kidney Failure Cohort Studies Communities Consensus Contrast Media Detection Development Diagnosis Dialysis procedure Disease Disease Outcome Dose Effectiveness of Interventions End stage renal failure Enrollment Ensure Event Face Family member Focus Groups Frequencies General Population Health Services Research Healthcare Healthcare Systems Hospitalization Hospitals Hypoglycemia Incidence Individual Intervention Kidney Kidney Diseases Lead Link Measurement Measures Medical Medical History Medication Errors Monitor Non-Steroidal Anti-Inflammatory Agents Online Systems Outcome Outcome Measure Participant Patient Care Patients Persons Pharmaceutical Preparations Pilot Projects Population Population Study Process Process Measure Provider Randomized Controlled Trials Recruitment Activity Renal function Research Design Review Literature Safety Sampling Series Serum Staging Surveys System Target Populations Telephone Testing Time Toxicant exposure Treatment Efficacy Validation Visit Work adverse outcome base cohort design follow-up high risk hyperkalemia improved member patient safety public health relevance therapy design volunteer web site

项目摘要

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].

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]。

项目成果

期刊论文数量（10）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis.

DOI：
10.2196/jmir.5203
发表时间：
2016-05-26
期刊：
Journal of medical Internet research
影响因子：
7.4
作者：
Fink JC;Doerfler RM;Yoffe MR;Diamantidis CJ;Blumenthal JB;Siddiqui T;Gardner JF;Snitker S;Zhan M
通讯作者：
Zhan M

Directed use of the internet for health information by patients with chronic kidney disease: prospective cohort study.