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].
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.
|Fink, Jeffrey C; Doerfler, Rebecca M; Yoffe, Marni R et al. (2016) Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis. J Med Internet Res 18:e125|
|Hsu, Kailin L; Fink, Jeffrey C; Ginsberg, Jennifer S et al. (2015) Self-reported Medication Adherence and Adverse Patient Safety Events in CKD. Am J Kidney Dis 66:621-9|
|Wu, Juliana; Ginsberg, Jennifer S; Zhan, Min et al. (2015) Chronic pain and analgesic use in CKD: implications for patient safety. Clin J Am Soc Nephrol 10:435-42|
|Diamantidis, Clarissa J; Ginsberg, Jennifer S; Yoffe, Marni et al. (2015) Remote Usability Testing and Satisfaction with a Mobile Health Medication Inquiry System in CKD. Clin J Am Soc Nephrol 10:1364-70|
|Wagner, Lee-Ann; Tata, Asha L; Fink, Jeffrey C (2015) Patient safety issues in CKD: core curriculum 2015. Am J Kidney Dis 66:159-69|
|Weir, Matthew R; Fink, Jeffrey C (2014) Safety of medical therapy in patients with chronic kidney disease and end-stage renal disease. Curr Opin Nephrol Hypertens 23:306-13|
|Ginsberg, Jennifer S; Zhan, Min; Diamantidis, Clarissa J et al. (2014) Patient-reported and actionable safety events in CKD. J Am Soc Nephrol 25:1564-73|
|Hartley, Iris R; Ginsberg, Jennifer S; Diamantidis, Clarissa J et al. (2013) Consideration of ICD-9 code-derived disease-specific safety indicators in CKD. Clin J Am Soc Nephrol 8:2123-31|
|Diamantidis, Clarissa Jonas; Fink, Wanda; Yang, Shiming et al. (2013) Directed use of the internet for health information by patients with chronic kidney disease: prospective cohort study. J Med Internet Res 15:e251|
|Diamantidis, Clarissa J; Zuckerman, Marni; Fink, Wanda et al. (2012) Usability of a CKD educational website targeted to patients and their family members. Clin J Am Soc Nephrol 7:1553-60|