When making health care decisions, patients, health care providers, and policymakers routinely seek unbiased information about the effects of treatment on a variety of health outcomes. Nonetheless, it is estimated that more than half of medical treatments lack valid evidence of effectiveness,1-3 particularly for long-term and patient-centered outcomes. These outcomes include humanistic measures such as the effects of treatment on quality of life, which may be among the most important factors that affect patients’ decisions about whether to use a treatment. In addition, therapies that demonstrate efficacy in well-controlled experimental settings like randomized controlled trials may perform differently in general clinical practice, where there is a wider diversity of patients, providers, and health care delivery systems.4-5 The effects of these variations on treatment are sometimes unknown but can significantly influence the net benefits and risks of different therapy options in individual patients.

OBJECTIVES/BACKGROUND:Lessons learned from the implementation of a pharmacist-delivered medication therapy management (MTM) intervention in primary care (PC) can inform future MTM studies and be adopted into real-world clinical settings. We sought to describe the variations and challenges of patient recruitment, enrollment, MTM pharmacist visits, and telephone follow-up in a 3-arm randomized trial of MTM interventions conducted at 3 health centers.STUDY DESIGN/METHODS:Using a post-study structured interview, we interviewed study personnel, clinical pharmacists, and investigators about 5 study domains: recruitment, enrollment visits, MTM pharmacist visits, telephone follow-up, and data collection.RESULTS:All centers screened clinic schedules and conducted queries of administrative databases to identify eligible participants. Patients were recruited either during existing primary care visits or by mailing letters with telephone follow-up. Patients with many medical problems, with transportation difficulties, or who were unaccompanied by a family member were less likely to enroll. MTM visits scheduled separately from other clinic appointments had higher cancellation or no-show rates. Provider response to pharmacist recommendations was low overall but better when the provider was acquainted with the pharmacist who was making contact.CONCLUSIONS:Off-site implementation of MTM services results in lower participation by patients and providers. Future MTM studies should consider integrating MTM services within the clinic during existing appointments by a pharmacist familiar to the primary care provider.

OBJECTIVETo evaluate the effect of a medication therapy management (MTM) intervention on adverse drug events (ADEs), health care visits, and drug-related problems (DRPs).DESIGNRandomized, controlled, clinical trial.SETTINGAcademic medical center community pharmacies and family medicine clinics at three U.S. sites between December 2007 and January 2010PATIENTSIndividuals aged 65 years or older with three or more chronic illnesses, six or more prescription medications, and at risk for a DRP.INTERVENTIONAt 0 and 3 months, pharmacists conducted comprehensive medication reviews and screened for and resolved DRPs through patient education and recommendations to physicians.MAIN OUTCOME MEASURESFrequency of ADEs reported by patients and confirmed by clinical algorithm, health care visits at 3 and 6 months, and number of DRPs, pharmacist recommendations, and medication discrepancies.RESULTS637 participants enrolled. No differences were observed in potential ADEs or health care visits among the usual care and MTM groups. DRPs declined in both MTM intervention groups over time. Physicians responded to 54.6% of pharmacist recommendations. Enhanced MTM patients had fewer medication list discrepancies than basic MTM patients (33.8% vs. 47.1%, P < 0.001).CONCLUSIONThis specific design of MTM was associated with reduced DRPs but did not reduce potential ADEs or health care visits.

Robot arms carry a unique set of challenges with setup for use with inverse kinematics. An automated calibration for such robots would prove beneficial. A solution is discussed utilizing accelerometer feedback on the tip of a robot arm and an automated calibration routine.

OBJECTIVE:To determine whether proactive telephone support improves adherence to antiretroviral therapy (ART) and clinical outcomes when compared to standard care.METHODS:A multisite, randomized controlled trial (RCT) was conducted with 109 ART-naive subjects coenrolled in AIDS Clinical Trials Group (ACTG) 384. Subjects received standard clinic-based patient education (SC) or SC plus structured proactive telephone calls. The customized calls were conducted from a central site over 16 weeks by trained registered nurses. Outcome measures (collected over 64 weeks) included an ACTG adherence questionnaire and 384 study endpoints.RESULTS:For the primary endpoint, self-reported adherence, a significantly better overall treatment effect was observed in the telephone group (P = 0.023). In a post hoc analysis, composite adherence scores, taken as the first 2 factor scores from a principal components analysis, also found significant intervention benefit (P = 0.023 and 0.019 respectively). For the 384 primary study endpoint, time to regimen failure, the Kaplan-Meier survival curve for the telephone group remained above the SC group at weeks 20 to 64; a Cox proportional hazard model that controlled for baseline RNA stratification, CD4, gender, age, race/ethnicity, and randomized ART treatment arm suggested the telephone group tended to have a lower risk for failure (hazard ratio = 0.68; 95% confidence interval: 0.38 to 1.23).CONCLUSIONS:Findings indicate that customized, proactive telephone calls have good potential to improve long-term adherence behavior and clinical outcomes.

Little is known about the effectiveness or optimal design of medication therapy management (MTM) programs as mechanisms for improving patient safety, motivating this multicenter trial sponsored by the Agency for Healthcare Research and Quality. Six hundred subjects at high risk of adverse drug events (ADEs) will be enrolled across three study sites. The study is designed as a randomized controlled trial with three arms. The control group (Arm 1) will receive usual care and have no MTM visits. Intervention groups (Arms 2 and 3) will undergo two MTM visits with a pharmacist over 6 months. The main safety outcomes are the number of ADEs, hospital admissions, and emergency room visits at 90 and 180 days, which will be compared among all three study arms. Additional safety outcomes include measures of MTM process and delivery. This paper details the methods of this study evaluating the impact of community-based MTM on enhancing patient safety.

Objectives: To evaluate the effects of using an audiovisual animation (i.e., digital video) displayed on a personal digital assistant (PDA) for patient education in a clinical setting.Methods: Quasi-experimental study of a prospective technology intervention conducted in an outpatient infectious diseases clinic at an academic medical center. Subjects responded to questions immediately before, immediately after, and 4-6 weeks after watching a digital video on a PDA. Outcome measures include participant knowledge of disease, knowledge of medications, and knowledge of adherence behaviors; attitudes toward the video and PDA; self-reported adherence; and practicality of the intervention.Results: Fifty-one English-speaking adults who were initiating or taking medications for the treatment of HIV/AIDS participated in the study. At visit one, statistically significant improvements in knowledge of disease (p < 0.005; paired t-test), knowledge of medications (p < 0.005; paired t-test), and knowledge of adherence behaviors (P < 0.05; ANOVA) were measured after participants watched the PDA-based video. At visit two (4-6 weeks later), statistically significant improvements in self-reported adherence to the medication regimens (p < 0.005; paired t-test) were reported. Participants liked the PDA-based video and indicated that it was an appropriate medium for learning, regardless of their baseline literacy skills. The video education process was estimated to take 25 min of participant time and was viewed in both private and semi-private locations.Conclusions: Technology-assisted education using a digital video delivered via PDA is a convenient and potentially powerful way to deliver health messages. The intervention was implemented efficiently with participants of a variety of ages and educational levels, and in a range of locations within clinical environments. Additional study of this methodology is warranted. (C) 2006 Elsevier Ireland Ltd. All rights reserved.

Highly active antiretroviral therapy (HAART) adherence rates of 90%-95% or more are required to be effective at treating the virus and preventing drug resistance. From both a medical and public health perspective, it is essential that HIV-positive clients strictly adhere to antiretroviral treatment regimens. One promising approach to promoting optimal adherence rates among HIV-positive individuals is training and reimbursing case managers to provide adherence coordination services to HIV-positive clients. In this study, a sample of 16 HIV/ AIDS case managers from agencies across North Carolina participated in a Case Management Adherence Training and Coordination Program for a 3-month period. After case manager training, case managers enrolled 1-4 of their existing clients, who met eligibility criteria, to receive the adherence coordination program. Data were analyzed from focus group interviews and individual interviews conducted with case manager participants; their respective client care plans were also analyzed to identify primary barriers and strategies reported by case managers. Although case managers perceived themselves to be well positioned to provide adherence coordination services for their HIV-positive clients, they also identified barriers that they face in providing these services, including lack of reimbursement for their time, inadequate training, and insufficient knowledge of HIV/AIDS and medications. The findings of this study suggest that, with appropriate training and reimbursement, HIV/AIDS case managers can play a pivotal role in promoting and improving client adherence to antiretroviral medications.

Aging is closely linked to a broad array of risk factors that are associated with chronic disease and declining health. With increasing age, most individuals will have a growing and sustained need for a variety of prescription drug therapies. In a survey of noninstitutionalized adults, 94% of women age 65 years or older had taken at least one medication in the preceding week, and 57% took at least five.1 In many cases, therapies are complex and costly and involve the services of multiple health care providers. Factors such as these enhance the potential for the occurrence of drug-related problems, including adverse drug events, drug interactions, and poor adherence to treatment plans.2,3 While the majority of older adults receive health care in ambulatory care settings, outpatient providers typically lack structured programs to accommodate geriatric needs and assist seniors with managing their medication regimens. Hence, it is not surprising that drug-related problems are frequent among older adults receiving outpatient care. Gurwitz et al.4 examined the frequency of adverse drug events among 27,617 Medicare beneficiaries receiving ambulatory care services and found the incidence was 50.1 adverse drug events per 1000 person-years of observation; 27.6% of these were classified as preventable. The results of the study suggest that new approaches are needed to improve the quality of care and health outcomes of older adults, especially in ambulatory care settings.

National surveys indicate that slightly less than one half of adults in the United States have low or limited literacy skills, 1. Kirsch I.S. Jungeblut A. Jenkins L. et al. Adult literacy in America: a first look at the results of the National Adult Literacy Survey. Washington, D.C, U.S. Department of Education1993 Google Scholar a hidden characteristic that often hinders effective communication among patients and their health care providers. Literacy is increasingly recognized as an important factor that may influence the course of treatment and several health outcomes. 2. Berkman N.D. DeWalt D.A. Pignone M.P. et al. Literacy and health outcomes. Agency for Healthcare Research and Quality, U.S. Dept. of Health and Human Services, Rockville, Md2004 Google Scholar Critical to the success of drug therapy is health literacy or the “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.” 3. Selden C. Zorn M. Ratzan S.C. Parker R.M. Health literacy [bibliography online]. National Library of Medicine, Bethesda, Md2000www.nlm.nih.gov/pubs/resources.html Google Scholar The importance of health literacy for the safety and effectiveness of health care is explained in a recent Institute of Medicine report, which includes all health care providers as part of a comprehensive plan to improve health literacy in America. 4. Health literacy: a prescription to end confusion. in: Nielsen-Bohlman L. Panzer A.M. Kindig D.A. Committee on Health Literacy, Board on Neuroscience and Behavioral Health, Institute of Medicine. National Academies Press, Washington, D.C.2004 Google Scholar

PURPOSEThe medication counseling practices of pharmacists caring for patients with HIV infection and the factors influencing their counseling behaviors regarding antiretroviral medications were examined.METHODSA questionnaire was mailed in February 2000 to pharmacist-managers of 573 ambulatory care pharmacies providing medications to beneficiaries of the North Carolina AIDS Drug Assistance Program. The frequency of and attitudes about adherence counseling for patients with HIV infection; the time allocated, spent, and needed to provide high-quality care to these patients; and pharmacists' time pressure and time stress were measured.RESULTSOf the 573 questionnaires mailed, 440 (77%) were usable. Fifty-nine percent of pharmacists reported that they did not have enough time to provide adherence counseling to patients receiving antiretroviral medications, and 45% reported that most of their patients did not receive such counseling. Time-stressed pharmacists were significantly less likely to perform 12 of 22 counseling behaviors, including discussing adverse effects (13% versus 24%, p < 0.0089), drug interactions (13% versus 31%, p < 0.0001), and what to do if a dose is missed (8% versus 23%, p < 0.0001). Multivariate analysis revealed that time stress, perceived skill and interest in adherence counseling, and job satisfaction were significantly associated with the counseling index.CONCLUSIONTime pressure and other barriers appeared to limit the care that some pharmacists offered to patients with HIV infection. Pharmacist age, job satisfaction, and perceived skill and interest in adherence counseling influenced the comprehensiveness of the counseling pharmacists provided for patients receiving antiretroviral medications.

BACKGROUND: Injudicious use of antibiotics is associated with the reported rise in antibiotic-resistant bacteria. With an estimated 26 million antibiotics being prescribed annually in the emergency department (ED), the ED represents an important setting for targeting interventions. OBJECTIVE: To provide national estimates of potentially inappropriate antibiotic prescribing during ED visits for acute respiratory tract infections (ARTIs) and examine associations between patient, provider, visit characteristics, and antibiotic prescribing patterns. METHODS: A cross-sectional study was conducted of ED visits for ARTIs, identified from pooled 1995–2000 National Hospital Ambulatory Medical Care Survey data. National estimates, descriptive statistics, and multivariate analyses were used to assess antibiotic prescribing patterns. RESULTS: An estimated 51.3 million ED visits for ARTIs occurred during the study period, 62% of which had an antibiotic prescribed. For a narrowly defined subset of ARTIs, where antibiotic therapy is nearly always inappropriate (eg, nasopharyngitis, ARTI of multiple or unspecified sites, acute bronchitis), the percentage decreased over the 6-year period from 57% to 44% (p < 0.01). For children ED visits, however, the downward trend occurred almost exclusively in urban EDs. Compared with visits in which a resident or intern physician was involved, the odds of antibiotic prescribing for child ED ARTI visits were 2.2 times higher for staff physicians (95% CI 1.3 to 3.6) and 1.8 times higher for nonphysicians with prescribing privileges (95% CI 1.3 to 2.4). CONCLUSIONS: ED antibiotic prescribing for ARTIs has decreased from 1995 to 2000, but still is occurring in well over half of ED visits for ARTI. Further research assessing knowledge and attitudes of patients and providers about antibiotic prescribing is needed.

It is widely recognized that adherence to antiretroviral therapy is critical to long-term treatment success, yet rates of adherence to antiretroviral medications are frequently subtherapeutic. Beliefs about antiretroviral therapy and psychosocial characteristics of HIV-positive persons naive to therapy may influence early experience with antiretroviral medication adherence and therefore could be important when designing programs to improve adherence to antiretroviral therapy. As part of a multicenter AIDS Clinical Trial Group (ACTG 384) study, 980 antiretroviral-naive subjects (82% male, 47% White, median age 36 years, and median CD4 cell count 278 cells/mm3) completed a self-administered questionnaire prior to random treatment assignment of initial antiretroviral medications. Measures of symptom distress, general health and well-being, and personal and situational factors including demographic characteristics, social support, self-efficacy, depression, stress, and current adherence to (nonantiretroviral) medications were recorded. Associations among variables were explored using correlation and regression analyses. Beliefs about the importance of antiretroviral adherence and ability to take antiretroviral medications as directed (adherence self-efficacy) were generally positive. Fifty-six percent of the participants were “extremely sure” of their ability to take all medications as directed and 48% were “extremely sure” that antiretroviral nonadherence would cause resistance, but only 37% were as sure that antiretroviral therapy would benefit their health. Less-positive beliefs about antiretroviral therapy adherence were associated with greater stress, depression, and symptom distress. More-positive beliefs about antiretroviral therapy adherence were associated with better scores on health perception, functional health, social–emotional–cognitive function, social support, role function, younger age, and higher education (r values = 0.09–0.24, all p < .001). Among the subset of 325 participants reporting current use of medications (nonantiretrovirals) during the prior month, depression was the strongest correlate of nonadherence (r = 0.33, p < .001). The most common reasons for nonadherence to the medications were “simply forgot” (33%), “away from home” (27%), and “busy” (26%). In conclusion, in a large, multicenter survey, personal and situational factors, such as depression, stress, and lower education, were associated with less certainty about the potential for antiretroviral therapy effectiveness and one's perceived ability to adhere to therapy. Findings from these analyses suggest a role for baseline screening for adherence predictors and focused interventions to address modifiable factors placing persons at high risk for poor adherence prior to antiretroviral treatment initiation