Jennifer L. Schneider

How to Design Computerized Alerts to Ensure Safe Prescribing Practices

Article-at-a-Glance Background Medication errors and preventable adverse drug events are common, and about half of medication errors occur during medication ordering. This study was designed to develop and evaluate medication safety alerts and processes for educating prescribers about the alerts. Methods At Kaiser Permanente Northwest, a group-model health maintenance organization where prescribers have used computerized order entry since 1996, qualitative interviews were conducted with 20 primary care prescribers. Results Prescribers considered alerts helpful for providing prescribing and preventive health information. More than half the interviewees stated that it would be unwise to let clinicians control or avoid safety alerts. Common frustrations were (1) being delayed by the alert, (2) having difficulty interpreting the alert, and (3) receiving the same alert repeatedly. Most prescribers preferred small-group educational sessions tied to existing meetings and having local physicians conduct education sessions. Discussion The findings were used to design a strategy for introducing and promoting the interventions, modifying the alert text and tools, and focusing the education on how clinicians could use the alerts effectively.

Automated Telephone Calls Improved Completion of Fecal Occult Blood Testing

Background:Although colorectal cancer (CRC) prognosis is improved by early diagnosis, screening rates remain low. Objective:To determine the effect of an automated telephone intervention on completion of fecal occult blood testing (FOBT). Research Design:In this randomized controlled trial conducted at Kaiser Permanente Northwest, a not-for-profit health maintenance organization, 5905 eligible patients aged 51 to 80, at average risk for CRC and due for CRC screening, were randomly assigned to an automated telephone intervention (n = 2943) or usual care (UC; n = 2962). The intervention group received up to three 1-minute automated telephone calls that provided a description and health benefits of FOBT. During the call, patients could request that an FOBT kit be mailed to their home. Those who requested but did not return the cards received an automated reminder call. Cox proportional hazard method was used to determine the independent effect of automated telephone calls on completion of an FOBT, after adjusting for age, sex, and prior CRC screening. Results:By 6 months after call initiation, 22.5% in the intervention and 16.0% in UC had completed an FOBT. Those in the intervention group were significantly more likely to complete an FOBT (hazard ratio, 1.31; 95% confidence interval, 1.10–1.56) compared with UC. Older patients (aged 71–80 vs. aged 51–60) were also more likely to complete FOBT (hazard ratio, 1.48; 95% confidence interval, 1.07–2.04). Conclusions:Automated telephone calls increased completion of FOBT. Further research is needed to evaluate automated telephone interventions among diverse populations and in other clinical settings.

Population-Representative Incidence of Drug-Induced Acute Liver Failure Based on an Analysis of an Integrated Health Care System

BACKGROUND & AIMS Medications are a major cause of acute liver failure (ALF) in the United States, but no population-based studies have evaluated the incidence of ALF from drug-induced liver injury. We aimed to determine the incidence and outcomes of drug-induced ALF in an integrated health care system that approximates a population-based cohort. METHODS We performed a retrospective cohort study using data from the Kaiser Permanente Northern California (KPNC) health care system between January 1, 2004, and December 31, 2010. We included all KPNC members age 18 years and older with 6 months or more of membership and hospitalization for potential ALF. The primary outcome was drug-induced ALF (defined as coagulopathy and hepatic encephalopathy without underlying chronic liver disease), determined by hepatologists who reviewed medical records of all KPNC members with inpatient diagnostic and laboratory criteria suggesting potential ALF. RESULTS Among 5,484,224 KPNC members between 2004 and 2010, 669 had inpatient diagnostic and laboratory criteria indicating potential ALF. After medical record review, 62 (9.3%) were categorized as having definite or possible ALF, and 32 (51.6%) had a drug-induced etiology (27 definite, 5 possible). Acetaminophen was implicated in 18 events (56.3%), dietary/herbal supplements in 6 events (18.8%), antimicrobials in 2 events (6.3%), and miscellaneous medications in 6 events (18.8%). One patient with acetaminophen-induced ALF died (5.6%; 0.06 events/1,000,000 person-years) compared with 3 patients with non-acetaminophen-induced ALF (21.4%; 0.18/1,000,000 person-years). Overall, 6 patients (18.8%) underwent liver transplantation, and 22 patients (68.8%) were discharged without transplantation. The incidence rates of any definite drug-induced ALF and acetaminophen-induced ALF were 1.61 events/1,000,000 person-years (95% confidence interval, 1.06-2.35) and 1.02 events/1,000,000 person-years (95% confidence interval, 0.59-1.63), respectively. CONCLUSIONS Drug-induced ALF is uncommon, but over-the-counter products and dietary/herbal supplements are its most common causes.

“Is It Worth Knowing?” Focus Group Participants’ Perceived Utility of Genomic Preconception Carrier Screening

As genome sequencing technology advances, research is needed to guide decision-making about what results can or should be offered to patients in different clinical settings. We conducted three focus groups with individuals who had prior preconception genetic testing experience to explore perceived advantages and disadvantages of genome sequencing for preconception carrier screening, compared to usual care. Using a discussion guide, a trained qualitative moderator facilitated the audio-recorded focus groups. Sixteen individuals participated. Thematic analysis of transcripts started with a grounded approach and subsequently focused on participants’ perceptions of the value of genetic information. Analysis uncovered two orientations toward genomic preconception carrier screening: “certain” individuals desiring all possible screening information; and “hesitant” individuals who were more cautious about its value. Participants revealed valuable information about barriers to screening: fear/anxiety about results; concerns about the method of returning results; concerns about screening necessity; and concerns about partner participation. All participants recommended offering choice to patients to enhance the value of screening and reduce barriers. Overall, two groups of likely users of genome sequencing for preconception carrier screening demonstrated different perceptions of the advantages or disadvantages of screening, suggesting tailored approaches to education, consent, and counseling may be warranted with each group.

An Outreach Program Improved Osteoporosis Management After a Fracture

This longitudinal retrospective cohort study evaluated implementation of an intervention to improve management of osteoporosis after a fracture in a nonprofit group‐model health maintenance organization (HMO) in the U.S. Pacific Northwest with 480,000 members and electronic medical record data. Participants were female HMO members aged 67 and older who sustained a qualifying clinical fracture(s) and who had not received a bone mineral density (BMD) measurement or osteoporosis treatment in the 12 months before the fracture (N=3,588). Phase 1 included outreach to clinicians and patients; Phase 2 added clinician and staff incentives. Primary outcome was “osteoporosis management”—receipt of a BMD measurement or osteoporosis medication in the 6 months after an index fracture. Before the intervention, 13.4% (95% confidence interval (CI)=12.0–14.8%) of patients had received osteoporosis management, and the time trend was not significant. Postintervention, the probability of osteoporosis management increased on average 3.1% (95% CI=2.6–3.5%) every 2 months throughout both study phases without a significant added improvement in Phase 2. Improvement varied according to clinic and was less likely for patients with dementia. Overall, the probability of osteoporosis management increased from the baseline level of 13.4% to 44.0% (95% CI=40.0–48.0%) by the end of the study period (20 months post‐intervention). The study found that an outreach program to primary care providers and patients improved the management of osteoporosis after a fracture. If widely implemented, this intervention could substantially improve the secondary prevention of osteoporosis. More‐individualized interventions may be necessary for high‐risk subgroups.

Cultivating Engaged Leadership Through a Learning Collaborative: Lessons From Primary Care Renewal in Oregon Safety Net Clinics

PURPOSE The aim of this study was to explore how learning collaboratives cultivate leadership skills that are essential for implementing patient-centered medical homes (PCMHs). METHODS We conducted an ethnographic evaluation of a payor-incentivized PCMH implementation in Oregon safety net clinics, known as Primary Care Renewal. Analyses primarily drew on in-depth interviews with organizational leaders who were involved in the initiative. We solicited perspectives on the history, barriers, facilitators, and other noteworthy factors related to the implementation of PCMH. We reviewed and summarized transcripts and created and applied a coding dictionary to identify emergent leadership themes. We reviewed field notes from clinic site visits and observations of learning collaborative activities for additional information on the role of engaged leadership. RESULTS Interview data suggested that organizations followed a similar, sequential process of Primary Care Renewal implementation having 2 phases—inspiration and implementation—and that leaders needed and learned different leadership skills in each phase. Leaders reported that collaborative learning opportunities were critical for developing engaged leadership skills during the inspiration phase of transformation. Facilitative and modeling aspects of engaged leadership were most important for codesigning a vision and plan for change. Adaptive leadership skills became more important during the implementation phase, when specific operational and management skills were needed to foster standardization and spread of the Primary Care Renewal initiative throughout participating clinics. CONCLUSIONS The PCMH has received much attention as a way to reorganize and potentially improve primary care. Documenting steps and stages for cultivating leaders with the vision and skills to transform their organizations into PCMHs may offer a useful roadmap to other organizations considering a similar transformation.

Oral Azole Antifungal Medications and Risk of Acute Liver Injury, Overall and by Chronic Liver Disease Status

BACKGROUND Reports on associations between azole antifungal medications and acute liver injury are inconsistent and have not been based on liver-related laboratory tests. We evaluated incidence rates of acute liver injury associated with oral azole antifungals. METHODS We conducted a cohort study among Kaiser Permanente Northern California members who initiated an oral azole antifungal in an outpatient setting during 2004-2010. We determined development of: (1) liver aminotransferases >200 U/L, (2) severe acute liver injury (coagulopathy with hyperbilirubinemia), and (3) acute liver failure. We calculated incidence rates of endpoints. Cox regression was used to determine whether chronic liver disease was a risk factor for outcomes. RESULTS Among 195,334 azole initiators (178,879 fluconazole; 14,296 ketoconazole; 1653 itraconazole; 478 voriconazole; 28 posaconazole), incidence rates (events/1000 person-years [95% confidence intervals (CIs)]) of liver aminotransferases >200 U/L were similarly low with fluconazole (13.0 [11.4-14.6]), ketoconazole (19.3 [13.8-26.3]), and itraconazole (24.5 [10.6-48.2]). Rates were higher with voriconazole (181.9 [112.6-278.0]) and posaconazole (191.1 [23.1-690.4]), but comparable. Severe acute liver injury was uncommon with fluconazole (2.0 [1.4-2.7]), ketoconazole (2.9 [1.1-6.3]), and itraconazole (0.0 [0.0-11.2]), but more frequent with voriconazole (16.7 [2.0-60.2]) and posaconazole (93.4 [2.4-520.6]). One patient developed acute liver failure due to ketoconazole. Pre-existing chronic liver disease increased risks of aminotransferases >200 U/L (hazard ratio 4.68 [95% CI, 3.68-5.94]) and severe acute liver injury (hazard ratio 5.62 [95% CI, 2.56-12.35]). CONCLUSIONS Rates of acute liver injury were similarly low for fluconazole, ketoconazole, and itraconazole. Events were more common among voriconazole and posaconazole users but were comparable. Pre-existing chronic liver disease increased risk of azole-induced liver injury.

Risk of Acute Liver Failure in Patients With Drug-Induced Liver Injury: Evaluation of Hy's Law and a New Prognostic Model.

BACKGROUND & AIMS Few studies have evaluated the ability of laboratory tests to predict risk of acute liver failure (ALF) among patients with drug-induced liver injury (DILI). We aimed to develop a highly sensitive model to identify DILI patients at increased risk of ALF. We compared its performance with that of Hys Law, which predicts severity of DILI based on levels of alanine aminotransferase or aspartate aminotransferase and total bilirubin, and validated the model in a separate sample. METHODS We conducted a retrospective cohort study of 15,353 Kaiser Permanente Northern California members diagnosed with DILI from 2004 through 2010, liver aminotransferase levels above the upper limit of normal, and no pre-existing liver disease. Thirty ALF events were confirmed by medical record review. Logistic regression was used to develop prognostic models for ALF based on laboratory results measured at DILI diagnosis. External validation was performed in a sample of 76 patients with DILI at the University of Pennsylvania. RESULTS Hys Law identified patients that developed ALF with a high level of specificity (0.92) and negative predictive value (0.99), but low level of sensitivity (0.68) and positive predictive value (0.02). The model we developed, comprising data on platelet count and total bilirubin level, identified patients with ALF with a C statistic of 0.87 (95% confidence interval [CI], 0.76-0.96) and enabled calculation of a risk score (Drug-Induced Liver Toxicity ALF Score). We found a cut-off score that identified patients at high risk patients for ALF with a sensitivity value of 0.91 (95% CI, 0.71-0.99) and a specificity value of 0.76 (95% CI, 0.75-0.77). This cut-off score identified patients at high risk for ALF with a high level of sensitivity (0.89; 95% CI, 0.52-1.00) in the validation analysis. CONCLUSIONS Hys Law identifies patients with DILI at high risk for ALF with low sensitivity but high specificity. We developed a model (the Drug-Induced Liver Toxicity ALF Score) based on platelet count and total bilirubin level that identifies patients at increased risk for ALF with high sensitivity.

Harnessing stakeholder perspectives to improve the care of osteoporosis after a fracture

SummaryThis study used in-depth interviews and focus groups to evaluate osteoporosis care after a fracture. Patients (eligible women aged 67 who sustained a clinical fracture(s)), clinicians, and staff stated that an outreach program facilitated osteoporosis care management, but more-tailored education and support and increased participation of orthopedic specialists appear necessary.IntroductionOsteoporosis treatment reduces fracture risk, but screening and treatment are underutilized, even after a fracture has occurred. This study evaluated key stakeholder perspectives about the care of osteoporosis after a fracture.MethodsParticipants were from a nonprofit health maintenance organization in the United States: eligible women members aged 67 or older who sustained a clinical fracture(s) (n = 10), quality and other health care managers (n = 20), primary care providers (n = 9), and orthopedic clinicians and staff (n = 28); total n = 67. In-depth interviews and focus groups elicited participant perspectives on an outreach program to patients and clinicians and other facilitators and barriers to care. Interviews and focus group sessions were transcribed and content-analyzed.ResultsPatients, clinicians, and staff stated that outreach facilitated osteoporosis care management, but important patient barriers remained. Patient knowledge gaps and fatalism were common. Providers stated that management needed to begin earlier, and longer-term patient support was necessary to address adherence. Orthopedic clinicians and staff expressed lack of confidence in their osteoporosis management but willingness to encourage treatment.ConclusionsAlthough an outreach program assisted with the management of osteoporosis after a fracture, more-tailored education and support and increased participation of orthopedic specialists appear necessary to maximize osteoporosis management.

Nonsteroidal Anti-Inflammatory Drug Use is Not Associated With Reduced Risk of Barrett’s Esophagus

Objectives:Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a reduced risk of esophageal adenocarcinoma. Epidemiological studies examining the association between NSAID use and the risk of the precursor lesion, Barrett’s esophagus, have been inconclusive.Methods:We analyzed pooled individual-level participant data from six case–control studies of Barrett’s esophagus in the Barrett’s and Esophageal Adenocarcinoma Consortium (BEACON). We compared medication use from 1,474 patients with Barrett’s esophagus separately with two control groups: 2,256 population-based controls and 2,018 gastroesophageal reflux disease (GERD) controls. Study-specific odds ratio (OR) and 95% confidence intervals (CI) were estimated using multivariable logistic regression models and were combined using a random-effects meta-analytic model.Results:Regular (at least once weekly) use of any NSAIDs was not associated with the risk of Barrett’s esophagus (vs. population-based controls, adjusted OR=1.00, 95% CI=0.76–1.32, I2=61%; vs. GERD controls, adjusted OR=0.99, 95% CI=0.82–1.19, I2=19%). Similar null findings were observed among individuals who took aspirin or non-aspirin NSAIDs. We also found no association with highest levels of frequency (at least daily use) and duration (≥5 years) of NSAID use. There was evidence of moderate between-study heterogeneity; however, associations with NSAID use remained non-significant in “leave-one-out” sensitivity analyses.Conclusions:Use of NSAIDs was not associated with the risk of Barrett’s esophagus. The previously reported inverse association between NSAID use and esophageal adenocarcinoma may be through reducing the risk of neoplastic progression in patients with Barrett’s esophagus.