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.

Public Health Relevance

This study will be an ancillary to the NIDDK-funded Chronic Renal Insufficiency Cohort (CRIC) study. The research plan is to retrospectively analyze stored CRIC data to determine the frequency of study-defined events related to medical care (safety incidents) and determine to what extent such events contribute to adverse outcomes in chronic kidney disease. NOTE: The criteria scores and the critiques given below were provided by the reviewers assigned to this application. These do not necessarily reflect the positions of the reviewers at the close of the group discussion or the final majority opinion of the group, although the reviewers were asked to amend their criteria scores and critiques if their positions changed during the discussion. Please note that the criteria scores are not averaged in arriving at the final overall impact scores. If the reviewers have not changed their criteria scores after the discussion, those shown in the critiques may reflect the opinion of the reviewers before the meeting. The Resume and other initial sections of the summary statement are the authoritative representations of the final outcome of the group discussion. If there is any discrepancy between the reviewers'commentaries and the priority/impact score on the face page of this summary statement, the priority/impact score should be considered the most accurate representation of the final outcome of the group discussion.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project (R01)
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Study Section
Special Emphasis Panel (ZDK1-GRB-7 (M5))
Program Officer
Eggers, Paul Wayne
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University of Maryland Baltimore
Internal Medicine/Medicine
Schools of Medicine
United States
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