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Importance: Clinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes. Objective: To determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A1c (HbA1c) levels. Design, Setting, and Participants: This randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA1c (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year. Interventions: The mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients' primary care physicians, including medication reconciliation and adjustment. Main Outcomes and Measures: Outcomes included HbA1c (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months. Results: Among the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA1c level was 9.23% (1.53%). Over the initial 12 months, HbA1c improved by a mean of -0.79 percentage points in the intervention group compared with -0.24 percentage points in the waiting list control group (treatment effect, -0.62; 95% CI, -1.04 to -0.19; P = .005). Over the subsequent 12 months, a significant change in HbA1c was observed in the waiting list control group after they received the same intervention (mean change, -0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, HbA1c levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach-delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities. Trial Registration: ClinicalTrials.gov Identifier: NCT02990299.

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OBJECTIVES: Uncontrolled hypertension is a common cause of cardiovascular disease, which is the deadliest and costliest chronic disease in the United States. Pharmacists are an accessible community healthcare resource and are equipped with clinical skills to improve the management of hypertension through medication therapy management (MTM). Nevertheless, current reimbursement models do not incentivize pharmacists to provide clinical services. We aim to investigate the cost-effectiveness of a pharmacist-led comprehensive MTM clinic compared with no clinic for 10-year primary prevention of stroke and cardiovascular disease events in patients with hypertension. METHODS: We built a semi-Markov model to evaluate the clinical and economic consequences of an MTM clinic compared with no MTM clinic, from the payer perspective. The model was populated with data from a recently published controlled observational study investigating the effectiveness of an MTM clinic. Methodology was guided using recommendations from the Second Panel on Cost-Effectiveness in Health and Medicine, including appropriate sensitivity analyses. RESULTS: Compared with no MTM clinic, the MTM clinic was cost-effective with an incremental cost-effectiveness ratio of $38 798 per quality-adjusted life year (QALY) gained. The incremental net monetary benefit was $993 294 considering a willingness-to-pay threshold of $100 000 per QALY. Health-benefit benchmarks at $100 000 per QALY and $150 000 per QALY translate to a 95% and 170% increase from current reimbursement rates for MTM services. CONCLUSIONS: Our model shows current reimbursement rates for pharmacist-led MTM services may undervalue the benefit realized by US payers. New reimbursement models are needed to allow pharmacists to offer cost-effective clinical services.

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BACKGROUND: Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence is necessary to minimize the adverse health outcomes of type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence prevent low-income, urban, and ethnic minority populations from achieving their management goals, resulting in diabetes complications. Health coaches working with clinical pharmacists represent a promising strategy for addressing common diabetes management barriers. Mobile health (mHealth) tools may further enhance their ability to support vulnerable minority populations in diabetes management. OBJECTIVE: The aim of this study is to evaluate the impact of an mHealth clinical pharmacist and health coach-delivered intervention on hemoglobin A1c (HbA1c, primary outcome), blood pressure, and low-density lipoprotein (secondary outcomes) in African-Americans and Latinos with poorly controlled type 2 diabetes. METHODS: A 2-year, randomized controlled crossover study will evaluate the effectiveness of an mHealth diabetes intervention delivered by a health coach and clinical pharmacist team compared with usual care. All patients will receive 1 year of team intervention, including lifestyle and medication support delivered in the home with videoconferencing and text messages. All patients will also receive 1 year of usual care without team intervention and no home visits. The order of the conditions received will be randomized. Our recruitment goal is 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (HbA1c ≥8%) receiving care from a largely minority-serving, urban academic medical center. The intervention includes the following: health coaches supporting patients through home visits, phone calls, and text messaging and clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA1c, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine the maintenance of any physiological improvement among participants receiving the intervention during the first year. RESULTS: Participant enrollment began in March 2017. We have recruited 221 patients. Intervention delivery and data collection will continue until November 2021. The results are expected to be published by May 2022. CONCLUSIONS: This is among the first trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among urban African-Americans and Latinos to achieve therapeutic goals. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17170.

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BACKGROUND: Atrial fibrillation (AF) increases the risk of stroke and direct oral anticoagulants (DOACs) are first-line agents for prevention. Gaps in the literature cause reluctance in prescribing DOACs for patients with renal dysfunction and/or extremes in body weight. OBJECTIVE: To evaluate the impact body weight and renal function have on major and clinically relevant nonmajor (CRNM) bleeding events and ischemic strokes in AF patients receiving a DOAC. METHODS: This retrospective cohort study included adults with nonvalvular atrial fibrillation (NVAF) or atrial flutter (AFL) receiving a DOAC ≥12 months. The primary outcome was a composite of major and CRNM bleeding events. Secondary outcomes included ischemic stroke and risk factors for bleeding events. RESULTS: Of the 233 patients analyzed, 25 patients experienced a bleeding event. Patients who bled weighed 10 kg less (P = 0.043) than those who did not and had a higher HASBLED score (P = 0.003). Multivariate logistic regression identified weight (P = 0.048), serum creatinine (SCr; P = 0.027), and HASBLED score (P = 0.024) as the significant predictors for experiencing a bleed. Three patients experienced a stroke. CONCLUSION AND RELEVANCE: This study demonstrates an association between higher baseline SCr, elevated HASBLED score, and lower weight, with an increased risk of bleeding in patients with NVAF or AFL receiving a DOAC. These findings add to prescribing considerations when initiating DOACs. Closer monitoring is advised for patients with significant renal dysfunction and/or low body weight, even with renal dose adjustments.

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OBJECTIVE: Clinical pharmacist support for patients with type 2 diabetes mellitus (T2DM) can optimize patient outcomes and medication adherence. However, there is limited understanding of what pharmacist roles patients perceive as most helpful in T2DM management interventions. This study describes experiences of minority patients with uncontrolled T2DM in terms of perceived pharmacist helpfulness and specific roles found to be most helpful within diabetes management. DESIGN: A secondary analysis of a 2-year randomized, crossover trial was conducted. SETTING AND PARTICIPANTS: This study included 244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model. OUTCOME MEASURES: The patients completed a mixed-methods survey regarding their experience with the intervention that included a general helpfulness rating on a 10-point unipolar Likert scale and described the support qualitatively, including their perception of the pharmacist roles. Thematic analysis guided coding of the responses. RESULTS: One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist. Of these, 108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women. The median rating of clinical pharmacist helpfulness was 10 (very helpful). Only 10 (7%) participants rated pharmacist helpfulness as 1 (not at all helpful). "Medication education and management" was the most frequently perceived supportive role of the clinical pharmacists, followed by "non-medication-related patient education," "social support," and "care coordination." Miscommunication related to scheduling was the most common reason cited for not meeting with the clinical pharmacist. CONCLUSION: This sample of minority patients with uncontrolled T2DM recognized many roles outlined within the American Pharmacists Association Medication Therapy Management framework. Patient experiences with clinical pharmacist T2DM support are crucial for developing effective programs, maximizing patient engagement, satisfying patient needs, and ensuring that a program's intended purpose aligns with the patient perspective.

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Prolongation of the corrected QT interval can lead to the deadly arrhythmia torsades de pointes. There are many risk factors for corrected QT prolongation, one being medication. The goal of this case report is to add to the limited literature surrounding the possibility of torsades de pointes when levofloxacin and fluconazole are used concomitantly. Additionally, provide guidance for patient factors that need to be assessed when prescribing the two drugs.

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BACKGROUND: Medication therapy management is widely promoted to improve care. However, few well-controlled studies have evaluated its impact. OBJECTIVES: We evaluated whether enrollment in a comprehensive medication therapy management clinic (MTMC) was associated with improved 12-month outcomes. METHODS: This institutional review board approved study was a retrospective controlled cohort study in an academic health center serving low-income, African American and Latino populations. Between 2001 and 2011 MTMC patients were matched to control patients by age, gender, and comorbidities. Outcomes were mean change in glycosylated hemoglobin (A1C), diastolic (DBP) and systolic blood pressure (SBP), and emergency department (ED) and hospital admissions at 6 and 12 months. A difference-in-difference analysis was conducted for each outcome of interest, adjusting for observed, unmatched confounders. RESULTS: Patients with diabetes and receiving MTMC had greater A1C improvements, compared with controls, of 0.54% (P = 0.0067) at 6 months and 0.63% (P = 0.0160) at 12 months. At 6 months, SBP and DBP decreased in MTMC patients by 6.5 mm Hg (P = 0.0108) and 3.8 mm Hg (P = 0.0136) more than controls, respectively. At 12 months, those receiving MTMC services had SBP and DBP decreases, respectively, of 8.2 mm Hg (P = 0.0018) and 1.7 mm Hg (P = 0.2691) compared with controls. ED and hospital visits were not statistically significantly different between groups. Conclusion and Relevance: This MTMC potentially improved outcomes for referred patients in whom target goals were difficult to achieve and can serve as a model for other similar medication management programs.

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OBJECTIVES: To evaluate the effectiveness of clinical pharmacists and community health workers (CHWs) in improving glycemic control within a low-income ethnic minority population. METHODS: In a two-arm 2-year crossover trial, 179 African-American and 65 Hispanic adult patients with uncontrolled diabetes mellitus (hemoglobin A1c [HbA1C] of 8% or higher) were randomized to CHW support either during the first or second year of the study. All participants received clinical pharmacist support for both years of the study. The primary outcome was change in HbA1C over 1 and 2 years. RESULTS: Similar HbA1C declines were noted after receiving the 1 year of CHW support: -0.45% (95% confidence interval [CI] -0.96 to 0.05) with CHW versus -0.42% (95% CI -0.93 to 0.08) without CHW support. In addition, no differences were noted in change on secondary outcome measures including body mass index, systolic blood pressure, high-density lipoprotein and low-density lipoprotein cholesterol, quality of life, and perceived social support. A difference in diastolic blood pressure change was noted: 0.80 mm Hg (95% CI -1.92 to 3.53) with CHW versus -1.85 mm Hg (95% CI -4.74 to 1.03) without CHW support (p=0.0078). Patients receiving CHW support had more lipid-lowering medication intensifications (0.39 [95% CI 0.27-0.52]) compared with those without CHW support (0.26 [95% CI 0.14-0.38], p<0.0001). However, no significant differences in intensification of antihyperglycemic and antihypertensive medications were observed between patients receiving CHW support and those without CHW support. Patients with low health literacy completed significantly more encounters with the pharmacist and CHW than those with high health literacy, although outcomes were comparable. CONCLUSIONS: No significant differences were noted between a clinical pharmacist-CHW team and clinical pharmacist alone in improving glycemic control within a low-income ethnic minority population.

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PURPOSE: In 2001, the University of Illinois Hospital and Health Sciences System (UI Health) established a pharmacist-run, referral-based medication therapy management clinic (MTMC). Referrals are obtained from any UI Health provider or by self-referral. Although there is a high volume of referrals, a large percentage of patients do not enroll. This study was designed to determine the various factors that influence patient enrollment in the MTMC. METHODS: This study was a retrospective chart review of demographic and patient variable data during years 2010 and 2011. Disabilities, distance from MTMC, mode of transportation, past medical history, and appointment dates were extracted from the medical records. Results were analyzed using descriptive statistics and logistic regression analysis. RESULTS: A total of 103 referrals were made; however, only 17% of patients remain enrolled in MTMC. The baseline demographics included a mean age of 63 years, 68% female, 70% African American, and 81% English speaking. Patients lived an average of 8 miles from MTMC; most utilized public or government-supplemented transport services; 24% of patients reported some type of disability, most commonly utilizing a walker or a wheelchair. On average, patients were prescribed 13 medications with hypertension (70%), diabetes (56%), and hyperlipidemia (48%) being the most common chronic disease states. The reason for referral included medication management, education, medication reconciliation, and disease state management. Five patients were unable to be contacted to schedule an initial appointment. Additionally, 18 patients failed their scheduled initial appointment and did not reschedule. Logistic regression analysis demonstrated distance traveled for clinic visit, age, and history of hypertension affected the probability of patients showing for their appointments (chi-square = 19.7, P < .001). CONCLUSION: This study demonstrated that distance from MTMC is the most common barrier in patient enrollment; therefore, strategies to improve patient access are necessary.

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OBJECTIVES: To qualitatively assess pharmacists' perspectives on the barriers and facilitators of collaborating with community health workers (CHWs) when caring for patients with diabetes. METHODS: Eight pharmacists were invited to participate in a focus group. All pharmacists had worked with CHWs for 12 months as part of a larger study. Seven pharmacists participated in a single focus group while one pharmacist participated in an individual interview. Data were analyzed by two investigators to identify common themes. RESULTS: Perceived barriers included issues associated with maintaining patient confidentiality, pharmacists' level of comfort with CHWs, uncertainty about CHW roles, and inconsistent communication between pharmacists and CHWs. However, pharmacists reported that the care model fostered improvement in patient-pharmacist communication, patient adherence to medication, and assessment of patients' overall condition. CONCLUSION: Pharmacists expressed positive attitudes and experiences in working with CHWs caring for a minority patient population with poorly controlled diabetes. Most believed that CHWs acted as facilitators and aided them in producing positive clinical outcomes by addressing the multiple psychosocial and contextual dimensions of patient health. Developing approaches for more frequent and effective communication between pharmacists and CHWs was the primary perceived challenge.

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BACKGROUND: Given the increasing prevalence of diabetes and the lack of patients reaching recommended therapeutic goals, novel models of team-based care are emerging. These teams typically include a combination of physicians, nurses, case managers, pharmacists, and community-based peer health promoters (HPs). Recent evidence supports the role of pharmacists in diabetes management to improve glycemic control, as they offer expertise in medication management with the ability to collaboratively intensify therapy. However, few studies of pharmacy-based models of care have focused on low income, minority populations that are most in need of intervention. Alternatively, HP interventions have focused largely upon low income minority groups, addressing their unique psychosocial and environmental challenges in diabetes self-care. This study will evaluate the impact of HPs as a complement to pharmacist management in a randomized controlled trial. METHODS/DESIGN: The primary aim of this randomized trial is to evaluate the effectiveness of clinical pharmacists and HPs on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels. A total of 300 minority patients with uncontrolled diabetes from the University of Illinois Medical Center ambulatory network in Chicago will be randomized to either pharmacist management alone, or pharmacist management plus HP support. After one year, the pharmacist-only group will be intensified by the addition of HP support and maintenance will be assessed by phasing out HP support from the pharmacist plus HP group (crossover design). Outcomes will be evaluated at baseline, 6, 12, and 24 months. In addition, program and healthcare utilization data will be incorporated into cost and cost-effectiveness evaluations of pharmacist management with and without HP support. DISCUSSION: The study will evaluate an innovative, integrated approach to chronic disease management in minorities with poorly controlled diabetes. The approach is comprised of clinic-based pharmacists and community-based health promoters collaborating together. They will target patient-level factors (e.g., lack of adherence to lifestyle modification and medications) and provider-level factors (e.g., clinical inertia) that contribute to poor clinical outcomes in diabetes. Importantly, the study design and analytic approach will help determine the differential and combined impact of adherence to lifestyle changes, medication, and intensification on clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01498159.

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In the US, the Medicare Modernization Act of 2003 required that Medicare Part D insurers provide medication therapy management (MTM) services (MTMS) to selected beneficiaries, with the goals of providing education, improving adherence, or detecting adverse drug events and medication misuse. These broad goals and variety in MTM programmes available make assessment of these programmes difficult. The objectives of this article are to review the definitions of MTMS proposed by various stakeholders, and to summarize and evaluate the outcomes of MTMS consistent with those that may be offered in Medicare Part D or reimbursed by State Medicaid programmes. MTM programmes are approved by the Centers for Medicare and Medicaid Services (CMS). Pharmacy, medical and insurance organizations have provided guidelines and definitions for MTM programmes, distinguishing them from other types of community pharmacy activities. MTM has been distinguished from disease state management because of the focus on medications and multiple conditions. It differs from patient counselling because it is delivered independent of dispensing and involves collaboration with patients and providers. There is no consensus on the recommended mode of delivery (i.e. face-to-face or by telephone) for MTM. A MEDLINE search was conducted to identify articles published after 2000 using the search terms 'medication therapy management' and 'medication management'. Studies with outcomes evaluating community-based programmes consistent with MTMS, regardless of MTMS reimbursement source, were included in the review. Seven publications describing four MTMS were identified. For each of the identified articles, we describe the study design, service setting, inclusion criteria and outcomes. An additional three surveys describing multiple MTMS were identified and are summarized. Finally, ongoing efforts by CMS to evaluate the success of MTMS in the US are described. To date, there are limited outcomes available for MTMS. The wide variety of MTMS offered means that evaluations of individual programmes are necessary. Despite the potential benefits of MTMS, there are numerous challenges to providing MTMS, including reimbursement, justification of the service and stakeholder acceptance of the services. There remains a need for adequately funded, prospective, controlled studies of MTM programmes using strong designs to advance our knowledge of the effectiveness of various interventions and methods of delivery, and for naturalistic studies assessing the impact of CMS approved MTM programmes.

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PURPOSE: Experience with a referral-based medication therapy management (MTM) clinic in a university medical center is described. SUMMARY: The MTM clinic's mission is to assist patients who take multiple medications due to multiple chronic conditions with the management of their drug therapy to improve or maintain their health and prevent or minimize drug-related problems. The clinical services provided at the clinic have evolved into a comprehensive program providing five distinct service areas: access, adherence, coordination of care, medication therapy review, and education. During initial visits, patient information is collected, patients are interviewed, medications are reconciled, and the pharmacist identifies and attempts to solve any immediate drug-related problems and concerns. Routine visits are scheduled monthly to coincide with a patient's medication refills. On a typical day, a minimum of two MTM pharmacists and one pharmacy technician staff the clinic. On two days of the week, three MTM pharmacists are available in the clinic. The clinic averages 9-13 scheduled patient visits per day. The MTM clinic functions as a subset of the outpatient pharmacy and is merged financially in the general operational budget of the ambulatory care pharmacy. This model of MTM patient care is intensive and comprehensive and is significantly different from the majority of MTM models currently provided by Medicare Part D plans. CONCLUSION: A referral-based MTM clinic managed by pharmacists at a university medical center outpatient pharmacy provides care to patients with the goal of improving medication access, medication adherence, continuity of care, medication therapy management, and patient education.

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