Background and objectives Inappropriate medication use is common in the care of patients with CKD. The feasibility of a simple mobile health tool designed to advise patients on safe medication usage in CKD was examined.Design, setting, participants, & measurements Participants with predialysis CKD (defined as eGFR,60 ml/min per 1.73 m 2 ) in the Safe Kidney Care Cohort Study were recruited for home usability testing of a novel medication inquiry system between January and September of 2013. Testing was through two mobile platforms: (1) short messaging service text or (2) personal digital assistant (e.g., iPod Touch). Twenty participants (one half assigned to one device and one half assigned to the other device) were enrolled and received an in-center tutorial on device usage before the end of the study visit. Participants were subsequently mailed three sample pill bottles with the name of randomly selected medications and asked to input these medications into the medication inquiry system. The medication inquiry system response options were as follows: (1) safe in CKD, (2) not safe in CKD, (3) use with caution/speak with your health care provider, or (4) error message (for an incorrectly inputted medication). Participants were asked to record the response issued by the medication inquiry system for each medication sent for usability testing. A user satisfaction survey was administered after completion of the protocol.Results All participants owned a mobile telephone, but few owned a smartphone. Of 60 total medication queries, there were only three recorded errors, two of which occurred in the short messaging service texting group. Overall satisfaction with the application was high, with slightly higher satisfaction noted in the personal digital assistant group compared with the short messaging service group. ConclusionsThe mobile health medication inquiry system application had general ease of use and high acceptance across two platforms among individuals representative of the CKD population. Tailored mobile health technology may improve medication safety in CKD.

Background Promoting medication adherence is a recognized challenge for prescribers. In this study we examine whether lower medication adherence is associated with adverse safety events in individuals with decreased estimated glomerular filtration rate (eGFR). Study Design Cross-sectional baseline analysis of prospective cohort. Setting & Participants Baseline analysis of the Safe Kidney Care (SKC) Cohort Study, a prospective study of individuals with an eGFR < 60 mL/min/1.73m2 intended to assess the incidence of disease-specific safety events. Kidney transplant recipients were excluded. Predictor Self-reported medication adherence based on responses to 3 questions ascertaining degree of medication regimen adherence. Outcomes Adverse safety events were self-reported at baseline (Class I events) such as hypoglycemia or fall thought related to a medication, or detected incidentally during the baseline visit (Class II events), for example hypotension or hyperkalemia. Potential drugrelated problems (DRPs) were determined by analyzing participants’ medications with respect to dosing guidelines based on their screening eGFR values at the time of medication reporting. Measurements Relationship between medication adherence and disease-specific patient safety events. Results Of 293 SKC participants, 154 (53%) were classified as having lower medication adherence. After multivariable adjustment, lower medication adherence was significantly associated with a Class I or II safety event (prevalence ratio [PR], 1.21; 95% CI, 1.04–1.41) and potential DRPs (PR, 1.29; 95% CI, 1.02–1.63). Lower medication adherence was also significantly associated with multiple (≥ 2) Class I events (PR, 1.71; 95% CI, 1.18–2.49), multiple Class I or II events (PR, 1.35; 95% CI, 1.04–1.76), and multiple potential DRPs (PR, 2.11; 95% CI, 1.08–2.69) compared to those with higher medication adherence. Limitations Use of self-reported medication adherence rather than pharmacy records. Clinical relevance of detected safety events is unclear. Conclusions Lower medication adherence is associated with adverse safety events in individuals with eGFR < 60 mL/min/1.73m2.

BackgroundHealth information technology has become common in the care of patients with chronic diseases; however, there are few such applications employed in kidney disease.ObjectiveThe aim of the study was to evaluate the use of a website providing disease-specific safety information by patients with predialysis chronic kidney disease.MethodsAs part of the Safe Kidney Care (SKC) study, an educational website was designed to provide information on safety concerns in chronic kidney disease. Phase I study participants were provided a medical alert accessory with a unique ID number, the Safe Kidney Care website, and an in-person tutorial on the use of the Internet and accessing the SKC website at baseline. Participants were asked to visit the website and enter their unique ID as frequently as they desired over the next 365 days or until their annual follow-up visit, whichever occurred first. Participants’ visits and dwell times on specific safety modules were tracked using embedded webpage PHP scripts linked to a MySQL database, enabling the collection of website usage statistics.ResultsOf 108 Phase I participants, 28.7% (31/108) visited the website from 1-6 times during the observation period (median follow-up 365 days). Median access time was 7 minutes per visit (range <1-46) and 13 minutes per person (range <1-123). The three most frequently visited pages were “Renal function calculator”, “Pills to avoid”, and “Foods to avoid”. High school education and frequent Internet use were significantly associated with website entry (P=.02 and P=.03, respectively).ConclusionsPreliminary results show general interest in a Web-based platform designed to improve patient safety in chronic kidney disease.Trial RegistrationClinicaltrials.gov NCT01407367; http://clinicaltrials.gov/show/NCT01407367 (Archived by WebCite at http://www.webcitation.org/6KvxFKA6M).

SummaryBackground and objectives Web-based technology is critical to the future of healthcare. As part of the Safe Kidney Care cohort study evaluating patient safety in CKD, this study determined how effectively a representative sample of patients with CKD or family members could interpret and use the Safe Kidney Care website (www. safekidneycare.org), an informational website on safety in CKD.Design, setting, participants, & measurements Between November of 2011 and January of 2012, persons with CKD or their family members underwent formal usability testing administered by a single interviewer with a second recording observer. Each participant was independently provided a list of 21 tasks to complete, with each task rated as either easily completed/noncritical error or critical error (user cannot complete the task without significant interviewer intervention).Results Twelve participants completed formal usability testing. Median completion time for all tasks was 17.5 minutes (range=10-44 minutes). In total, 10 participants had greater than or equal to one critical error. There were 55 critical errors in 252 tasks (22%), with the highest proportion of critical errors occurring when participants were asked to find information on treatments that may damage kidneys, find the website on the internet, increase font size, and scroll to the bottom of the webpage. Participants were generally satisfied with the content and usability of the website.Conclusions Web-based educational materials for patients with CKD should target a wide range of computer literacy levels and anticipate variability in competency in use of the computer and internet.

Assessing the performance at self-management of patients with CKD is essential for effective strategies to safeguard care. We evaluated the use of a sick-day protocol with structured usability testing by patients with CKD. The Sick-Day Protocol is a selfmanagement protocol developed by National Health Service Highland in Scotland to prevent AKI, and it is made available through the Scottish Patient Safety Program on a "Medicine Sick Day Rules" card (1). The Sick-Day Protocol card describes a gastrointestinal or fever-related and volume-depleting illness; then, it directs patients to withhold specified medications and resume them when well (after 24-48 hours of eating and drinking normally). Five medication classes and examples are listed, including angiotensinconverting enzyme inhibitors, angiotensin receptor blockers, diuretics, nonsteroidal anti-inflammatory drugs, and metformin. We recruited volunteers with stages 3-5 CKD from the Safe Kidney Care program (2). All participants independently scheduled and completed testing. The protocol was deemed exempt by the University of Maryland Baltimore Institutional Review Board. Usability testing sessions were conducted in a private room by a moderator and recorder. Participants were educated about the purpose of the Sick-Day Protocol and qualifying illnesses. The moderator presented the card to all participants and requested each to summarize it in their own words. The study team developed four scenarios representing commonly encountered medical problems. All were reviewed and adjudicated by two physicians (C.J.D. and J.C.F.) for clinical validity and population suitability. Participants were presented the scenarios, including one for which the Sick-Day Protocol would be appropriately activated (index) and one with nonqualifying illnesses, including nephrolithiasis, congestive heart failure, and a "minor" gastrointestinal illness. One half of the sample had scenarios presented in a fixed sequence, starting with the index. The remainder had the scenarios presented randomly. The moderator reviewed the mock patient's medications and comorbidities in each scenario and then, provided mock medication bottles. Participants were asked about the appropriateness of the Sick-Day Protocol, if any of the mock medications should be withheld in each scenario, and if so, which ones. Completion of each task was classified as a success or error. After completing

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Background and objectivesPoor disease recognition may jeopardize the safety of CKD care. We examined safety events and outcomes in patients with CKD piloting a medical-alert accessory intended to improve disease recognition and an observational subcohort from the same population.Design, setting, participants, & measurementsWe recruited 350 patients with stage 2–5 predialysis CKD. The first (pilot) 108 participants were given a medical-alert accessory (bracelet or necklace) indicating the diagnosis of CKD and displaying a website with safe CKD practices. The subsequent (observation) subcohort (n=242) received usual care. All participants underwent annual visits with ascertainment of patient-reported events (class 1) and actionable safety findings (class 2). Secondary outcomes included 50% GFR reduction, ESKD, and death. Cox proportional hazards assessed the association of the medical-alert accessory with outcomes.ResultsMedian follow-up of pilot and observation subcohorts were 52 (interquartile range, 44–63) and 37 (interquartile range, 27–47) months, respectively. The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits (P=0.13), and 38.3 events and 41.2 events per 100 patient visits (P=0.23), respectively. The medical-alert accessory was associated with lower crude and adjusted rate of ESKD versus the observation group (hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.89; and hazard ratio, 0.38; 95% confidence interval, 0.16 to 0.94, respectively). The association of the medical-alert accessory with the composite endpoint of ESKD or 50% reduction GFR was variable over time but appeared to have an early benefit (up to 23 months) with its use. There was no significant difference in incidence of hospitalization, death, or a composite of all outcomes between medical-alert accessory users and the observational group.ConclusionsThe medical-alert accessory was not associated with incidence of safety events but was associated with a lower rate of ESKD relative to usual care.