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Steinman M.A.,University of California at San Francisco | Steinman M.A.,San Francisco Veterans Affairs Medical Center | Handler S.M.,University of Pittsburgh | Handler S.M.,Veterans Affairs Pittsburgh Health Care System | And 5 more authors.
Journal of the American Geriatrics Society | Year: 2011

Whether a person will suffer harm from a medication or how severe that harm will be is difficult to predict precisely. As a result, many adverse drug events (ADEs) occur in patients in whom it was reasonable to believe that the drug's benefits exceeded its risks. Improving safety and reducing the burden of ADEs in older adults requires addressing this uncertainty by not only focusing on the appropriateness of the initial prescribing decision, but also by detecting and mitigating adverse events once they have started to occur. Such enhanced monitoring of signs, symptoms, and laboratory parameters can determine whether an adverse event has only mild and short-term consequences or major long-term effects on morbidity and mortality. Although current medication monitoring practices are often suboptimal, several strategies can be leveraged to improve the quality and outcomes of monitoring. These strategies include using health information technology to link pharmacy and laboratory data, prospective delineation of risk, and patient outreach and activation, all within a framework of team-based approaches to patient management. Although many of these strategies are theoretically possible now, they are poorly used and will be difficult to implement without a significant restructuring of medical practice. An enhanced focus on medication monitoring will also require a new conceptual framework to re-engineer the prescribing process. With this approach, prescribing quality does not hinge on static attributes of the initial prescribing decision but entails a dynamic process in which the benefits and harms of drugs are actively monitored, managed, and reassessed over time. © 2011, The American Geriatrics Society.


News Article | November 28, 2016
Site: www.eurekalert.org

ATLANTA--While most primary care physicians would provide some information about a medical error, only a minority would fully disclose important information about potentially harmful medical errors to patients, a new survey shows. Most of the nearly 300 primary care physicians would provide only partial disclosure of a medical error for two hypothetical cases involving cancer diagnoses they were asked to evaluate. Most would offer only a limited or no apology, limited or no explanation and limited or no information about the cause. The researchers report disclosure by physicians in this study falls short of patient expectations and national guidelines. The findings are published in the journal BMJ Quality and Safety. The purpose of this study was to examine the extent to which primary care physicians' perceptions of event-level, physician-level and organization-level factors influence their intent to disclose a medical error in challenging situations. The strongest predictors of disclosure were perceived personal responsibility, perceived seriousness of the event and perceived value of patient-centered communication. "The intent to disclose was not as frequent as we thought it might be," said Dr. Douglas Roblin, professor in the Division of Health Management and Policy in the School of Public Health at Georgia State University and researcher at the Center for Clinical and Outcomes Research at Kaiser Permanente Georgia. "The two vignettes gave pretty consistent findings. The majority would not fully disclose, and we were hoping for full disclosure because that is the ethical expectation." Full disclosure of harmful errors to patients, including a statement of regret, an explanation, acceptance of responsibility and commitment to prevent recurrences, has been the standard for physicians in the United States for nearly a decade. However, researchers said there is evidence that effective disclosure often doesn't occur. An absent or poor response by clinicians can make a bad situation much worse, while full disclosure could lessen the negative impact. Understanding the factors affecting providers' tendency to disclose is important to developing effective interventions to improve physician-patient communication. Participants in this study were primary care physicians from three integrated healthcare delivery systems in Washington, Massachusetts and Georgia, which were part of the HMO Cancer Research Network's Cancer Communication Research Center. A total of 333 primary care physicians out of 630 responded to the survey. The majority of respondents (71 percent) had been in practice for more than 10 years, over half (55.6 percent) indicated they often questioned whether the demand of their practice was worth the toll and over a third (36.7 percent) often thought about leaving practice. In the vignettes, physicians were asked to evaluate two difficult, but realistic, hypothetical cases: 1) a delayed diagnosis of breast cancer and 2) a care coordination breakdown that caused a delayed response to patient symptoms. Both cases involved oncology diagnoses and multiple physicians sharing responsibility for the error. Each vignette was followed by four questions asking what the physician would be likely to say with respect to an apology, an explanation, information about the cause of the event and plans for preventing recurrences. Physicians could choose from non-disclosure, partial disclosure and full disclosure responses. Participants also assessed event-level, physician-level and organization-level factors for each vignette. Event-level factors include personal responsibility for the event, beliefs about the seriousness of the event and predictions as to whether the patient would file a lawsuit as a result of the event. Physician-level factors include the value placed on patient-centered communication, self-efficacy with respect to communication and feelings about practice. Organization-level factors include perceived support for communication and time constraints. The study found the majority of respondents would not fully disclose a harmful medical error in either vignette situation, providing only a limited or no apology, limited or no explanation and limited or no information about the cause. When asked what they would tell the patient about the cause of the error, 77 percent of physicians for the case involving delayed diagnosis of cancer and 58 percent of physicians for the case involving a care coordination breakdown would offer either no information or make vague references to miscommunications. In both cases, more than half would not volunteer an apology or would offer only a vague expression of regret. Physicians would be more forthcoming in the care coordination breakdown compared to the delayed cancer diagnosis, but most would provide only partial disclosure after either of the events. The researchers conclude that in order to make meaningful progress toward improving disclosure, physicians, risk managers, organizational leaders, professional organizations and accreditation bodies need to understand the factors that influence disclosure. This insight, which could be achieved by using vignette-based surveys, is necessary to update institutional policies and provider training. Collaborators for the study include lead author Kathleen Mazor of the Meyers Primary Care Institute in Worcester, Mass., and University of Massachusetts Medical School; Sarah M. Greene of the Health Care Systems Research Network; Hassan Fouayzi of the Meyers Primary Care Institute in Worcester, Mass., and University of Massachusetts Medical School; and Thomas H. Gallagher of the Department of Medicine at University of Washington in Seattle. The study was funded by the National Cancer Institute.


Blake D.R.,University of Massachusetts Medical School | Lemay C.A.,University of Massachusetts Medical School | Kearney M.H.,University of Rochester | Mazor K.M.,Meyers Primary Care Institute
Archives of Pediatrics and Adolescent Medicine | Year: 2011

Objective: To identify ways to improve adolescents' understanding of informed assent by exploring adolescent comprehension of concepts common to all clinical trials as well as those specific to a human immunodeficiency virus vaccine trial. Design: Qualitative descriptive study. Setting: Community-based organizations. Participants: Healthy adolescents aged 15 to 17 years in 8 focus groups. Intervention: Focus groups were conducted using a semistructured interview guide. Digital recordings of the groups were transcribed verbatim. Outcome Measure: Textual data were categorized by 2 investigators using directed qualitative content analysis techniques. Major themes and subthemes were identified, and representative quotes were selected. Results: The general research concepts that were most difficult for teens to understand were placebo and randomization. The most difficult vaccine trial concepts were how a vaccine works and that a vaccine is used for prevention rather than treatment. The most difficult human immunodeficiency virus vaccine - specific trial concept was that standard human immunodeficiency virus antibody tests might provide a false-positive result for participants receiving the test vaccine. Focus group participants wanted to be informed about adverse effects, trial procedures, and whether previous research had been performed before making a decision about trial participation. Conclusions: Many clinical trial concepts were difficult for teens to understand. Attention needs to be directed toward developing effective ways to explain these concepts to adolescents participating in future human immunodeficiency virus vaccine and other clinical trials. ©2011 American Medical Association. All rights reserved.


Pimentel C.B.,University of Massachusetts Medical School | Briesacher B.A.,Northeastern University | Gurwitz J.H.,Meyers Primary Care Institute | Rosen A.B.,University of Massachusetts Medical School | And 2 more authors.
Journal of the American Geriatrics Society | Year: 2015

Objectives To assess improvements in pain management of nursing home (NH) residents with cancer since the implementation of pain management quality indicators. Design Cross-sectional. Setting One thousand three hundred eighty-two U.S. NHs (N = 1,382). Participants Newly admitted, Medicare-eligible NH residents with cancer (N = 8,094). Measurements Nationwide data on NH resident health from Minimum Data Set 2.0 linked to all-payer pharmacy dispensing records (February 2006-June 2007) were used to determine prevalence of pain, including frequency and intensity, and receipt of nonopioid and opioid analgesics. Multinomial logistic regression was used to evaluate resident-level correlates of pain and binomial logistic regression to identify correlates of untreated pain. Results More than 65% of NH residents with cancer had any pain (28.3% daily, 37.3%


Briesacher B.A.,University of Massachusetts Medical School | Quittner A.L.,University of Miami | Saiman L.,Columbia University | Sacco P.,Novartis | And 2 more authors.
BMC Pulmonary Medicine | Year: 2011

Background: Adherence with tobramycin inhalation solution (TIS) during routine cystic fibrosis (CF) care may differ from recommended guidelines and affect health care utilization.Methods: We analyzed 2001-2006 healthcare claims data from 45 large employers. Study subjects had diagnoses of CF and at least 1 prescription for TIS. We measured adherence as the number of TIS therapy cycles completed during the year and categorized overall adherence as: low ≤ 2 cycles, medium >2 to <4 cycles, and high ≥ 4 cycles per year. Interquartile ranges (IQR) were created for health care utilization and logistic regression analysis of hospitalization risk was conducted by TIS adherence categories.Results: Among 804 individuals identified with CF and a prescription for TIS, only 7% (n = 54) received ≥ 4 cycles of TIS per year. High adherence with TIS was associated with a decreased risk of hospitalization when compared to individuals receiving ≤ 2 cycles (adjusted odds ratio 0.40; 95% confidence interval 0.19-0.84). High adherence with TIS was also associated with lower outpatient service costs (IQR: $2,159-$8444 vs. $2,410-$14,423) and higher outpatient prescription drug costs (IQR: $35,125-$60,969 vs. $10,353-$46,768).Conclusions: Use of TIS did not reflect recommended guidelines and may impact other health care utilization. © 2011 Briesacher et al; licensee BioMed Central Ltd.


Tjia J.,University of Massachusetts Medical School | Briesacher B.A.,University of Massachusetts Medical School | Peterson D.,Meyers Primary Care Institute | Liu Q.,Wistar Institute | And 2 more authors.
JAMA Internal Medicine | Year: 2014

IMPORTANCE: Advanced dementia is characterized by severe cognitive impairment and complete functional dependence. Patients' goals of care should guide the prescribing of medication during such terminal illness. Medications that do not promote the primary goal of care should be minimized. OBJECTIVES: To estimate the prevalence of medications with questionable benefit used by nursing home residents with advanced dementia, identify resident- and facility-level characteristics associated with such use, and estimate associated medication expenditures. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional study of medication use by nursing home residents with advanced dementia using a nationwide long-term care pharmacy database linked to the Minimum Data Set (460 facilities) between October 1, 2009, and September 30, 2010. MAIN OUTCOMES AND MEASURES: Use of medication deemed of questionable benefit in advanced dementia based on previously published criteria and mean 90-day expenditures attributable to these medications per resident. Generalized estimating equations using the logit link function were used to identify resident- and facility-related factors independently associated with the likelihood of receiving medications of questionable benefit after accounting for clustering within nursing homes. RESULTS: Of 5406 nursing home residents with advanced dementia, 2911 (53.9%) received at least 1 medication with questionable benefit (range, 44.7%in the Mid-Atlantic census region to 65.0% in the West South Central census region). Cholinesterase inhibitors (36.4%), memantine hydrochloride (25.2%), and lipid-lowering agents (22.4%) were the most commonly prescribed. In adjusted analyses, having eating problems (adjusted odds ratio [AOR], 0.68; 95% CI, 0.59-0.78), a feeding tube (AOR, 0.58; 95% CI, 0.48-0.70), or a do-not-resuscitate order (AOR, 0.65; 95% CI, 0.57-0.75), and enrolling in hospice (AOR, 0.69; 95% CI, 0.58-0.82) lowered the likelihood of receiving these medications. High facility-level use of feeding tubes increased the likelihood of receiving these medications (AOR, 1.45; 95% CI, 1.12-1.87). The mean (SD) 90-day expenditure for medications with questionable benefit was $816 ($553), accounting for 35.2% of the total average 90-day medication expenditures for residents with advanced dementia who were prescribed these medications. CONCLUSIONS AND RELEVANCE: Most nursing home residents with advanced dementia receive medications with questionable benefit that incur substantial associated costs. Copyright 2014 American Medical Association. All rights reserved.


Harrold L.R.,University of Massachusetts Medical School | Briesacher B.A.,University of Massachusetts Medical School | Peterson D.,Meyers Primary Care Institute | Beard A.,University of Michigan | And 4 more authors.
Journal of Rheumatology | Year: 2013

Objective. Economic access to costly medications including biologic agents can be challenging. Our objective was to examine whether patients with rheumatoid arthritis (RA) are at particular risk for cost-related medication nonadherence (CRN) and spending less on basic needs. Methods. We identified a nationally representative sample of older adults with RA (n = 1100) in the Medicare Current Beneficiary Survey (2004-2008) and compared them to older adults with other morbidities categorized by chronic disease count: 0 (n = 5898), 1-2 (n = 30,538), and ≥ 3 (n = 34,837). We compared annual rates of self-reported CRN (skipping or reducing medication doses or not obtaining prescriptions because of cost) as well as spending less on basic needs to afford medications and tested for differences using survey-weighted logistic regression analyses adjusted for demographic characteristics, health status, and prescription drug coverage. Results. In the RA sample, the unadjusted weighted prevalence of CRN ranged from 20.7% in 2004 to 18.4% in 2008 as compared to 18.5% and 11.9%, respectively, in patients with 3 or more non-RA conditions. In adjusted analyses, having RA was associated with a 3.5-fold increase in the risk of CRN (OR 3.52, 95% CI 2.63-4.71) and almost a 2.5-fold risk of spending less on basic needs (OR 2.41, 95% CI 1.78-3.25) as compared to those without a chronic condition. Conclusion. Patients with RA experience a high prevalence of CRN and forgoing of basic needs, more than do older adults with multiple other chronic conditions. The situation did not improve during a period of policy change aimed at alleviating high drug costs. Copyright © 2013 The Journal of Rheumatology.


Li D.-K.,Kaiser Permanente | Yang C.,Kaiser Permanente | Andrade S.,Meyers Primary Care Institute | Tavares V.,Kaiser Permanente | Ferber J.R.,Kaiser Permanente
BMJ (Online) | Year: 2011

Objective: To examine a reported association between use of angiotensin converting enzyme (ACE) inhibitors during the first trimester and risk of malformations in offspring. Design: A population based, retrospective cohort study linking automated clinical and pharmacy databases including comprehensive electronic medical records. Participants: Pregnant women and their live born offspring (465 754 mother-infant pairs) in the Kaiser Permanente Northern California region from 1995 to 2008. Main outcome measure: Congenital malformation in live births. Results: The prevalence of ACE inhibitor use in the first trimester only was 0.9/1000, and the use of other antihypertensive medications was 2.4/1000. After adjustment for maternal age, ethnicity, parity, and obesity, use of ACE inhibitors during the first trimester only seemed to be associated with increased risk of congenital heart defects in offspring compared with normal controls (those with neither hypertension nor use of any antihypertensives during pregnancy) (15/381 (3.9%) v 6232/400 021 (1.6%) cases, odds ratio 1.54 (95% confidence interval 0.90 to 2.62)). A similar association was observed for use of other antihypertensives (28/1090 (2.6%) cases of congenital heart defects, odds ratio 1.52 (1.04 to 2.21)). However, compared with hypertension controls (those with a diagnosis of hypertension but without use of antihypertensives) (708/29 735 (2.4%) cases of congenital heart defects), neither use of ACE inhibitors or of other antihypertensives in the first trimester was associated with increased congenital heart defects risk (odds ratios 1.14 (0.65 to 1.98) and1.12 (0.76 to 1.64) respectively). Conclusions: Maternal use of ACE inhibitors in the first trimester has a risk profile similar to the use of other antihypertensives regarding malformations in live born offspring. The apparent increased risk of malformations associated with use of ACE inhibitors (and other antihypertensives) in the first trimester is likely due to the underlying hypertension rather than the medications.


Fischer S.H.,University of Massachusetts Medical School | Fischer S.H.,Meyers Primary Care Institute | Tjia J.,University of Massachusetts Medical School | Tjia J.,Meyers Primary Care Institute | And 2 more authors.
Journal of the American Medical Informatics Association | Year: 2010

Medication errors are a major source of morbidity and mortality. Inadequate laboratory monitoring of high-risk medications after initial prescription is a medical error that contributes to preventable adverse drug events. Health information technology (HIT)-based clinical decision support may improve patient safety by improving the laboratory monitoring of high-risk medications, but the effectiveness of such interventions is unclear. Therefore, the authors conducted a systematic review to identify studies that evaluate the independent effect of HIT interventions on improving laboratory monitoring for high-risk medications in the ambulatory setting using a Medline search from January 1, 1980 through January 1, 2009 and a manual review of relevant bibliographies. All anticoagulation monitoring studies were excluded. Eight articles met the inclusion criteria, including six randomized controlled trials and two pre-post intervention studies. Six of the studies were conducted in two large, integrated healthcare delivery systems in the USA. Overall, five of the eight studies reported statistically significant, but small, improvements in laboratory monitoring; only half of the randomized controlled trials reported statistically significant improvements. Studies that found no improvement were more likely to have used analytic strategies that addressed clustering and confounding. Whether HIT improves laboratory monitoring of certain high-risk medications for ambulatory patients remains unclear, and further research is needed to clarify this important question.


Naci H.,Harvard University | Naci H.,The London School of Economics and Political Science | Soumerai S.B.,Harvard University | Ross-Degna D.,Harvard University | And 5 more authors.
Health Affairs | Year: 2014

Elderly Americans, especially those with multiple chronic conditions, face difficulties paying for prescriptions, which results in worse adherence to and discontinuation of therapy, called cost-related medication nonadherence. Medicare Part D, implemented in January 2006, was supposed to address issues of affordability for prescriptions. We investigated whether the gains in medication affordability attributable to Part D persisted during the six years that followed its implementation. Overall, we found continued incremental improvements in medication affordability in the period 2007-09 that eroded during the period 2009-11. Among elderly beneficiaries with four or more chronic conditions, we observed an increase in the prevalence of cost-related nonadherence from 14.4 percent in 2009 to 17.0 percent in 2011, reversing previous downward trends. Similarly, the prevalence among the sickest elderly of forgoing basic needs to purchase medicines decreased from 8.7 percent in 2007 to 6.8 percent in 2009 but rose to 10.2 percent in 2011. Our findings highlight the need for targeted policy efforts to alleviate the persistent burden of drug treatment costs on this vulnerable population. © 2014 by Project HOPE - The People-to-People Health Foundation.

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