Patients with all stages of kidney disease are at a high risk of harm related to medical care (adverse safety events). These events may occur outside of the medical system and are often under-reported or under- appreciated. Health information technology (HIT) offers novel means to track [patient-reported] adverse safety events in kidney disease, and reveal new data to providers that can lead to beneficial treatment modifications. Hypothesis: An [interactive voice response system (IVRS) that records patient-reported adverse safety events via telephone (eDiary), and is useable by a majority of kidney patients], will increase the detection of adverse safety events and [have a positive impact on clinical management].
Specific aims : 1) An IVRS eDiary will be offered to patients with pre-dialysis chronic kidney disease (CKD) with the intent of determining its effectiveness in detecting previously under-reported adverse safety events. 2) A version of the IVRS eDiary will be provided to patients with end-stage renal disease (ESRD) on hemodialysis to determine its effectiveness in detecting adverse safety events outside the dialysis unit. [In both aims the patient-reported safety events recorded via paper safety diary and the IVRS eDiary will be compared and presented in regular reports to primary providers to assess the impact of this new information on clinical care]. Device (intervention): [an IVRS platform (CarePlan ManagerTM) adapted for the target population]. Study design: a cross-over design comparing a paper-based symptom diary to the IVRS eDiary. Study population: 1) CKD patients (n=50) in the Safe Kidney Care (SKC) cohort study (R01DK084017), and 2) ESRD patients (n =50) who receive hemodialysis at Independent Dialysis Foundation (IDF) dialysis facilities in Baltimore. Study Measurements: established disease-specific (CKD) adverse safety incidents (CKD-PSI) endorsed by the SKC expert consensus panel with the addition of ESRD-pertinent safety events [along with any additional free-text or voice-based patient-reported safety events]. Outcomes: Counts of adverse safety events recorded via paper diary versus IVRS eDiary will be classified in individual safety categories and also treated as a composite. [Providers'categorical responses to safety reports will also be ascertained]. Analytic plans: Adjusted rates of events expressed as counts per month will be compared as recorded in the paper vs eDiary using GEE Poisson regression within each sub-group (CKD and ESRD) and as a combined cohort. [Provider responses to safety reports will be tallied at the participant-level and compared across diary groups.] Relevance: An eDiary introduced to kidney disease patients with a wide range in proficiency with technology, and designed to detect potentially harmful patient safety incidents beyond the boundaries of the health care system, will offer new opportunities to improve care and outcomes characteristic of this disease.

Public Health Relevance

This study will evaluate an interactive voice response system (IVRS) eDiary designed to detect and report on adverse safety events in kidney disease patients compared to a paper diary and determine the impact of this information on clinical care when reported to primary providers.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Exploratory/Developmental Grants (R21)
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Special Emphasis Panel (ZRG1-DKUS-L (81))
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Narva, Andrew
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University of Maryland Baltimore
Internal Medicine/Medicine
Schools of Medicine
United States
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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