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].

Public Health Relevance

Chronic kidney disease (CKD) is common, and often goes unrecognized among patients using the health care system where improving patient safety has become a high priority. We will validate the use CKD-specific patient safety indicators and pilot the use of a Medi-alert bracelet and necklace to increase the recognition of CKD, and evaluate its efficacy in reducing the frequency of CKD-specific safety events.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project (R01)
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Study Section
Kidney, Nutrition, Obesity and Diabetes (KNOD)
Program Officer
Narva, Andrew
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University of Maryland Baltimore
Internal Medicine/Medicine
Schools of Medicine
United States
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