Do Patient Safety Events Account for Adverse Outcomes in CKD?

患者安全事件会导致 CKD 的不良后果吗？

• 批准号: 8332112
• 负责人: JEFFREY C FINK
• 金额: $ 39.36万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-20 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8332112
• 关键词: Accounting; Acute Renal Failure with Renal Papillary Necrosis; Adverse event; Allopurinol; Ancillary Study; Atenolol; Cardiovascular system; Caring; Categories; Cessation of life; Chronic Kidney Failure; Chronic Kidney Insufficiency; Code; Cohort Studies; Data; Disease; Disease Outcome; Disease Progression; Dose; Electrolytes; End stage renal failure; Event; Exposure to; Frequencies; Funding; Glomerular Filtration Rate; Glyburide-metformin; Health Services Research; Hospitalization; Hospitals; Hypoglycemia; ICD-9; Impaired Renal Function; Incidence; Intoxication; Kidney; Kidney Diseases; Laboratories; Link; Measurement; Measures; Medical; Medication Errors; Metabolic; Methods; National Institute of Diabetes and Digestive and Kidney Diseases; Nomenclature; Non-Steroidal Anti-Inflammatory Agents; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Population; Population Study; Prevalence; Protein Structure Initiative; Records; Renal function; Research; Research Design; Risk Factors; Role; Safety; Subgroup; Surveys; Telephone; Time; United States Agency for Healthcare Research and Quality; Visit; Walking; Work; adverse outcome; base; cohort; health care quality; high risk; hyperkalemia; mortality; patient safety; pill

DESCRIPTION (provided by applicant): Persons with chronic kidney disease (CKD) are susceptible to an array of potentially harmful events related to their care (safety events). However, [there has been little work to establish a nomenclature for CKD-relevant safety events], to examine the prevalence of these safety events, or to determine the role of safety events in the incidence of poor CKD outcomes. Hypothesis: Patients with CKD have a high frequency of both general (PSI) and disease-specific patient safety incidents (CKD-PSI) that account for a significant proportion of adverse events leading to poor disease outcomes. Overall aims: Examine the prevalence of disease-specific CKD-PSI [designated as triggers] and general PSI in the CKD population, and determine whether the incidence of these PSIs cause adverse events which account for poor CKD outcomes. Specific aims: 1a) Determine the frequency of medication errors (one set of CKD-PSI) in a CKD cohort. 1b) Compare the rate of adverse events among subjects who have had one or more medication-related CKD-PSI as defined in (1a) to that of their counterparts who have not had such an event. 2a) Determine the incidence of electrolyte/metabolic disturbances including hyperkalemia and hypoglycemia (2nd set of CKD-PSIs) in a CKD cohort. 2b) Compare rate of adverse events in subjects who have had one or more electrolyte disturbance as defined in (2a) to that of their counterparts who have not had such an event. 3a) Examine the incidence of both AHRQ-defined PSI and a 3rd set of CKD-PSI (both ICD-9 code-derived) during hospitalizations of persons in CKD cohort. 3c) Compare the rate of adverse events in subjects who had a hospitalization and a PSI as defined in (3a) to that of their counterparts with a hospitalization and no such event. Study design: Retrospective (ancillary) study of an existing cohort. Study population: Participants (n = 3939) in the NIDDK- sponsored Chronic Renal Insufficiency Cohort (CRIC) study. Study Measurements: Medication records (30 day recall), including over-the-counter pills, determined at i) baseline, ii) the first semiannual interim phone visit, and iii) repeated annually. Medication errors will be determined using a renal drug reference cross-walk and CRIC estimates of glomerular filtration rate (GFR). Electrolyte disturbances (principally, but not exclusively, hyperkalemia and hypoglycemia) will be recorded from baseline and annual laboratory values. Additionally, ICD-9 codes from hospitalization over the course of CRIC observation will be reviewed for AHRQ- PSI and CKD-PSI. Outcomes: Participants will be tracked for adverse events including hospitalization, loss of renal function, ESRD and CVD events, and mortality. Analytic plans: Longitudinal and repeated measures methods will be employed to estimate the relationship between designated CKD-PSI (both as composite and relevant subgroups) and adverse events with focus on events occurring within one year of safety incidents. Relevance: This study will determine the extent to which harmful consequences of medical care (safety events) contribute to the characteristically poor outcomes of CKD.

描述（由申请人提供）：慢性肾病 (CKD) 患者容易遭受与其护理相关的一系列潜在有害事件（安全事件）。然而，[几乎没有建立 CKD 相关安全事件的命名法]、检查这些安全事件的发生率或确定安全事件在 CKD 不良结局发生率中的作用。假设：CKD 患者发生一般性 (PSI) 和疾病特异性患者安全事件 (CKD-PSI) 的频率很高，这些事件在导致不良疾病结果的不良事件中占很大比例。总体目标：检查 CKD 人群中疾病特异性 CKD-PSI（指定为触发因素）和一般 PSI 的患病率，并确定这些 PSI 的发生率是否会导致导致不良 CKD 结局的不良事件。具体目标： 1a) 确定 CKD 队列中用药错误的频率（一组 CKD-PSI）。 1b) 将患有（1a）中定义的一种或多种药物相关 CKD-PSI 的受试者与未发生此类事件的受试者的不良事件发生率进行比较。 2a) 确定 CKD 队列中电解质/代谢紊乱的发生率，包括高钾血症和低血糖（第二组 CKD-PSIs）。 2b) 将发生过（2a）中定义的一种或多种电解质紊乱的受试者与未发生过此类事件的受试者的不良事件发生率进行比较。 3a) 检查 CKD 队列中患者住院期间 AHRQ 定义的 PSI 和第三组 CKD-PSI（均源自 ICD-9 代码）的发生率。 3c) 将住院且发生（3a）中定义的 PSI 的受试者的不良事件发生率与住院但未发生此类事件的受试者的不良事件发生率进行比较。研究设计：现有队列的回顾性（辅助）研究。研究人群：NIDDK 赞助的慢性肾功能不全队列 (CRIC) 研究的参与者 (n = 3939)。研究测量：用药记录（30 天回忆），包括非处方药，在 i) 基线、ii) 第一次半年中期电话就诊和 iii) 每年重复确定。将使用肾脏药物参考交叉分析和肾小球滤过率 (GFR) 的 CRIC 估计来确定用药错误。电解质紊乱（主要但不限于高钾血症和低血糖）将根据基线和年度实验室值进行记录。此外，还将对 CRIC 观察期间住院期间的 ICD-9 代码进行 AHRQ-PSI 和 CKD-PSI 审查。结果：将跟踪参与者的不良事件，包括住院、肾功能丧失、ESRD 和 CVD 事件以及死亡率。分析计划：将采用纵向和重复测量方法来估计指定的 CKD-PSI（作为复合亚组和相关亚组）与不良事件之间的关系，重点关注安全事件一年内发生的事件。相关性：本研究将确定医疗保健的有害后果（安全事件）在多大程度上导致 CKD 典型的不良结局。