Mobile Health Intervention in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

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.

The Impact of Body Weight and Renal Function on the Risk of Bleeding With Direct Oral Anticoagulants in Atrial Fibrillation.

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.

Clinical pharmacists in diabetes management: What do minority patients with uncontrolled diabetes have to say?

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.

Impact of a Medication Therapy Management Clinic on Glycosylated Hemoglobin, Blood Pressure, and Resource Utilization.

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.

Concomitant use of levofloxacin and fluconazole leading to possible torsades de pointes.

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.

Community Health Workers Supporting Clinical Pharmacists in Diabetes Management: A Randomized Controlled Trial.

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.

Medication therapy management services: definitions and outcomes.

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.