EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial.

BACKGROUND: Approximately 10-15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use. METHODS: Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs. RESULTS: Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %. CONCLUSION: The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.

Improving glycemic control in diabetes through virtual interdisciplinary rounds.

OBJECTIVE: A team-based disease management approach that considers comorbid conditions, social drivers of health, and clinical guidelines improves diabetes care but can be costly and complex. Developing innovative models of care is crucial to improving diabetes outcomes. The objective of this analysis was to evaluate the efficacy of virtual interdisciplinary diabetes rounds in improving glycemic control. STUDY DESIGN: Retrospective cohort study using observational data from July 2018 to December 2021. METHODS: This study employed difference-in-differences analysis to compare change in hemoglobin A1c (HbA1c) in a group of patients whose providers received advice as part of virtual interdisciplinary rounds and a group of patients whose providers did not receive rounds advice. Patients with diabetes were identified for rounding (1) based on attribution to an accountable care organization along with an upcoming primary care appointment and an HbA1c between 8% and 9% or (2) via provider referral. RESULTS: The rounded group consisted of 481 patients and the comparison group included 1806 patients. There was a 0.3-point reduction in HbA1c (95% CI, 0.1-0.4) associated with rounds overall. In a subanalysis comparing provider adoption of recommendations among those rounded, provider adoption was associated with an HbA1c reduction of 0.5 points (95% CI, 0.1-0.9) at 6 months post rounds, although there was no significant difference in the full year post rounds. CONCLUSIONS: Interdisciplinary rounds can be an effective approach to proactively provide diabetes-focused recommendations. This modality allows for efficient, low-cost, and timely access to an endocrinologist and team to support primary care providers in diabetes management.

Content Variation of Catechin Markers, Total Phenolics and Caffeine in Green Tea Dietary Supplements.

Green tea (Camellia sinensis) preparations are among the top selling products in the United States dietary supplements market. Numerous manufacturers claim different levels of specific catechin markers in their products while many others use total phenolic concentration instead, or not at all. Limited quality control results have been published for green tea dietary supplements over the past seven years. Thus, the goal of this work was to correlate determined levels of phenolics, catechins, and caffeine with manufacturer label claims for selected dietary supplement products (26 total) purchased in the United States. The Folin-Ciocalteu (FC) method was used to determine the total phenolic content while reversed-phase (RP) HPLC was used to quantify the major catechins: epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECG), epigallocatechin gallate (EGCG). The developed HPLC method was validated for accuracy and precision. It utilized a C8 column with gradient elution of acetonitrile in 0.1% aqueous formic acid over 11 min total run time. Peak detection was performed at 280 nm. Caffeine was also included in the HPLC method as another non-phenolic alkaloid marker commonly found in green tea. Both methods showed a good correlation between the content of catechins and polyphenolic compounds in the selected products. The ranges of total catechins and polyphenol concentrations were 3.8-70.2% and 3.6-95.8%, respectively, while that of caffeine was 0.8-11.2%. The selected products displayed a wide range of marker levels. A lack of conformity in disclosing the actual levels of marker compounds was also noticed in the labeling of many products.

Evaluation of cost versus antioxidant determinants in green tea dietary supplements.

OBJECTIVE: To investigate the association between cost and (a) chemical constituents and (b) antioxidant activity as quality determinants of select green tea supplements available in the United States. DESIGN/SETTING: Laboratory analysis of green tea using HPLC and antioxidant assay methods. MAIN OUTCOME MEASURES: Correlation between selected quality parameters and daily cost based on the serving size as stated in the label. Quality was defined in terms of (a) catechin levels (validated high-performance liquid chromatography method), (b) total phenolic content (Folin-Ciocalteu method), and (c) antioxidant activity (total antioxidant capacity and diphenylpicryl hydrazyl free-radical scavenging). RESULTS: A wide range of variation in marker levels and antioxidant activity was observed in the evaluated products. Catechin levels correlated well with the total phenolic content in each product while antioxidant activities were not as consistent when correlated with catechin/polyphenol levels. There was also a low correlation between product cost and quality. CONCLUSION: Our results indicate that product cost does not always reflect quality, at least within the selected range of products. Thus, for a pharmacist to be able to recommend quality green tea dietary supplements, factors other than cost should be considered.

A Chronic Disease State Simulation in an Ambulatory Care Elective Course.

OBJECTIVE: To implement a chronic disease state simulation in an ambulatory care elective course and to assess the simulation's impact on students' perceptions of their empathy toward patients and of their counseling skills. DESIGN: The chronic disease state simulation occurred over 2 weeks. Students alternated playing the role of patient and pharmacist. As patients, students adhered to medication regimens, lifestyle modifications, and blood glucose or blood pressure monitoring. As pharmacists, students conducted patient interviews, and provided education and counseling. Empathy and counseling skills were assessed through course surveys, written reflections, and SOAP notes. ASSESSMENT: Results from a cohort of 130 students indicated the simulation enhanced students' perceptions of their abilities to empathize with and counsel patients with chronic diseases. CONCLUSION: The chronic disease state simulation provides a novel approach to develop skills needed for working with complex patient cases in ambulatory care settings.