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We share our experience on the strategies implemented for identifying and enrolling participants in a randomized remote implementation trial. We aimed to evaluate the effectiveness of various digital and traditional screening and outreach methods in participant enrollment. This study focuses on understanding the success and challenges associated with different approaches to patient engagement., Competing Interests: Conflict of interest/Disclosures Lee-Shing Chang: Applied Therapeutics, Better Therapeutics, Boehringer Ingelheim, Corcept Therapeutics, Eli Lilly, Fractyl Health, Novo Nordisk, Rhythm Pharmaceuticals, Sanofi Christopher Cannon: Research Grants – Amgen, Better Therapeutics, Boehringer Ingelheim, Daiichi Sankyo, Merck, Novo Nordisk, Pfizer; Consulting – Amryt/Chiesi, Alnylam, Amarin, Amgen, Applied Therapeutics, Ascendia, Biogen, Boehringer Ingelheim, Bristol Myers-Squibb, CSL Behring, Eli Lilly, Janssen, Lexicon, Merck, Milestone, Pfizer, Rhoshan, Sanofi Deborah Wexler: Novo Nordisk, Vertex Benjamin M. Scirica: Research Grants – Better Therapeutics, Boehringer Ingelheim, Merck, NovoNordisk, and Pfizer. Consulting – Abbvie (DSMB), AstraZeneca (DSMB), Boehringer Ingelheim, Better Therapeutics, Bristol Myers-Squibb, Elsevier Practice Update Cardiology, Esperion, Hanmi (DSMB), Lexeo (DSMB), Lexicon, NovoNordisk; Equity – Health [at] Scale and Doximity. Alexander J. Blood: Research Grants – Boehringer Ingelheim, Novo Nordisk, Eli Lilly, General Electric Health; Consulting – Medscape, Novo Nordisk, Milestone Therapeutics, Walgreens, Color Health, Arsenal Capital Partners; Equity – Knownwell Other authors have no disclosures., (Copyright © 2024. Published by Elsevier Inc.)

An estimated 45% of adult Americans currently have high blood pressure (HBP). Effective blood pressure (BP) control is essential for preventing major adverse events from cardiovascular and other vascular-related diseases, such as chronic kidney disease, stroke and dementia. A large and growing number of medical professional societies, health care organizations, and governmental agencies have now endorsed a clinical practice guideline-based target for adequate control of HBP to a systolic BP of less than 130 mm Hg. However, adequate BP control to this goal has been recently estimated to be as low as 30%. The first and most important steps to guide effective BP control include accurate, standardized BP measurement and formal assessment of overall atherosclerotic cardiovascular disease risk. In addition to appropriate pharmacologic treatment, optimal BP management must also include multifaceted guideline-directed lifestyle modifications. High-quality evidence now supports effective uniform HBP control that is consistently achievable for most of people from diverse backgrounds. This can be accomplished through identification and prioritization of social determinants of health enabled by shared decision making that is delivered via team-based care. Such integrated approaches can have a substantial impact for simultaneously reducing several major modifiable atherosclerotic cardiovascular disease risk factors. Hence, moving the "Big Needle" of improved overall cardiovascular, kidney, and brain health of the US population must no longer be solely relegated to primary care and will require a major and coordinated reprioritization of capital and evidence-based human resource allocations by all health care stakeholder organizations., Competing Interests: Dr Casey reports participation as follows: National Committee for Quality Assurance (NCQA) Cardiovascular Measure Advisory Panel (no financial remuneration); National Hypertension Control Initiative (NHCI) Advisory Board (no financial remuneration); and Advisory Board for Collaboration Oriented Approach for Controlling High Blood Pressure (COACH) Oregon Health and Science University Grant Number U18 HS026849. Dr Blood reports institutional grants from Eli Lilly, Boehringer Ingelheim, Milestone Therapeutics, and Novo Nordisk; consulting fees from Color Health, Arsenal Capital Partners, Milestone Therapeutics, Novo Nordisk, Signum Technologies, Knownwell Health, Porter Health, and Scriptchain; honoraria from Medscape ; travel support from American College of Cardiology and American Heart Association; U.S. Patent application No 16/636,524 entitled “Smartphone Application for Medical Image Data Sharing and Team Activation”; participation in data safety monitoring board of HI-Pro; equity options in Knownwell and Porter Health. Dr Persell receives research funding paid to Northwestern University from 10.13039/100016274Omron Healthcare, National Institutes of Health, Agency for Healthcare Reseach and Quality, Health Resources and Services Administration, and 10.13039/100007059Northwestern Memorial Healthcare; consulting fees from RAND; and honoraria from Pri-Med, Omron Healthcare, and National Committee for Quality Assurance. Dr Pohlman reports no competing interests. Dr Williamson reports grants from National Institutes of Health, Alzheimer’s Association, and Biogen; honorarium from University of New South Wales and Arbor Acres Retirement Community; and participation in the boards of Impact of Intensive Treatment of Systolic Blood Pressure on Brain Perfusion, Amyloid and Tau in Older Adults, National Institute on Aging; Pharmaceutical Assistance to the Aged and Disabled, National Institute on Aging; and Blood Pressure Control Target in Diabetes, National Research and Development Institute of China., (© 2024 The Authors.)

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have noted benefits in the treatment of type 2 diabetes, cardiovascular disease, heart failure, and chronic kidney disease. Despite these benefits, the adoption of SGLT2i in clinical practice has been slow. Early initiation of SGLT2i during hospitalization has been proposed to address this gap for 2 important reasons: 1) it provides early clinical benefit in multiple disease states; and 2) hospitalization presents an opportunity for medication optimization and patient education, thereby overcoming clinical inertia. Challenges in SGLT2i adoption necessitate innovative strategies for integration into clinical practice. Ongoing trials and novel care delivery models are anticipated to further elucidate effective strategies for SGLT2i implementation and adherence. This review synthesizes the accrued evidence of SGLT2i across various chronic diseases. It emphasizes the rationale for early in-hospital initiation and discusses barriers and potential solutions for widespread implementation of SGLT2i in hospitalized patients., Competing Interests: This work was supported by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Lilly USA, LLC. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). The authors received no payment related to the development of the manuscript. Graphical support was provided by Envision Pharma Group, contracted and funded by Boehringer Ingelheim Pharmaceuticals, Inc (BIPI) and Lilly USA, LLC. BIPI and Lilly were given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Dr Unlu has received funding from the 10.13039/100000050National Heart Lung and Blood Institute under award number T32HL007604. Dr Bhatt has received grant support to his institution from 10.13039/100000002National Institutes of Health/10.13039/100000050National Heart, Lung, and Blood Institute, 10.13039/100000002National Institutes of Health/10.13039/100000049National Institute on Aging, 10.13039/100005485American College of Cardiology Foundation, and the 10.13039/100000030Centers for Disease Control and Prevention and has received consulting fees from Sanofi Pasteur, Novo Nordisk, and the Kinetix Group. Dr Blood has received grant support from Novo Nordisk, 10.13039/100001003Boehringer Ingelheim, GE Healthcare, 10.13039/100004312Eli Lilly; consulting fees from Walgreens Health, Color Health, Flare Capital, Arsenal Capital Partners, Novo Nordisk, Milestone Pharmaceuticals; and has equity holdings in Knownwell; and has received grant support from National Institutes of Health/ National Heart, Lung, and Blood Institute and under Equity “Signum Technologies and Porter Health”., (© 2024 The Authors.)

Background: Several SGLT2i (sodium-glucose transport protein 2 inhibitors) and GLP1-RA (glucagon-like peptide-1 receptor agonists) reduce cardiovascular events and improve kidney outcomes in patients with type 2 diabetes; however, utilization remains low despite guideline recommendations., Methods: A randomized, remote implementation trial in the Mass General Brigham network enrolled patients with type 2 diabetes with increased cardiovascular or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP1-RA were randomly assigned to simultaneous virtual patient education with concurrent prescription of SGLT2i or GLP1-RA (ie, Simultaneous) or 2 months of virtual education followed by medication prescription (ie, Education-First) delivered by a multidisciplinary team driven by nonlicensed navigators and clinical pharmacists who prescribed SGLT2i or GLP1-RA using a standardized treatment algorithm. The primary outcome was the proportion of patients with prescriptions for either SGLT2i or GLP1-RA by 6 months., Results: Between March 2021 and December 2022, 200 patients were randomized. The mean age was 66.5 years; 36.5% were female, and 22.0% were non-White. Overall, 30.0% had cardiovascular disease, 5.0% had cerebrovascular disease, and 1.5% had both. Mean estimated glomerular filtration rate was 77.9 mL/(min‧1.73 m 2 ), and mean urine/albumin creatinine ratio was 88.6 mg/g. After 2 months, 69 of 200 (34.5%) patients received a new prescription for either SGLT2i or GLP1-RA: 53.4% of patients in the Simultaneous arm and 8.3% of patients in the Education-First arm ( P <0.001). After 6 months, 128 of 200 (64.0%) received a new prescription: 69.8% of patients in the Simultaneous arm and 56.0% of patients in Education-First ( P <0.001). Patient self-report of taking SGLT2i or GLP1-RA within 6 months of trial entry was similarly greater in the Simultaneous versus Education-First arm (69 of 116 [59.5%] versus 37 of 84 [44.0%]; P <0.001) Median time to first prescription was 24 (interquartile range [IQR], 13-50) versus 85 days (IQR, 65-106), respectively ( P <0.001)., Conclusions: In this randomized trial, a remote, team-based program identifies patients with type 2 diabetes and high cardiovascular or kidney risk, provides virtual education, prescribes SGLT2i or GLP1-RA, and improves guideline-directed medical therapy. These findings support greater utilization of virtual team-based approaches to optimize chronic disease management., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06046560., Competing Interests: Disclosures Dr Blood reports grants from Boehringer Ingelheim, Novo Nordisk, Eli Lilly, General Electric Health; consulting for Color Health, Arsenal Capital Partners, Walgreens Health, Medscape, Novo Nordisk; and equity in Knownwell. Dr Chang reports research grants via Brigham and Women’s Hospital from Applied Therapeutics, Better Therapeutics, Boehringer Ingelheim, Corcept Therapeutics, Eli Lilly, Fractyl Health, Novo Nordisk, Rhythm Pharmaceuticals, and Sanofi. Dr Hassan reports grants from Better Therapeutics, Boehringer Ingelheim, and Novo Nordisk. J. Chasse reports grants from Boehringer Ingelheim and Novo Nordisk. S. J. Aronson reports research grants via Brigham and Women’s Hospital from Better Therapeutics, Boehringer Ingelheim, and NovoNordisk; via Mass General Brigham from the National Institutes of Health; and consulting for Nest Genomics. Drs Noone and Robar and E. Zacherle are employees of Novo Nordisk. Dr Plutzky reports grant support from Boehringer Ingelheim; and consulting for Janssen and Novo Nordisk. Dr Gaziano reports grant support from the National Institutes of Health and Novartis; and consulting for Novartis, Multiply Labs, Amgen, DalCor, and Dimagi. Dr Cannon reports research grants from Amgen, Better Therapeutics, Boehringer Ingelheim, Daiichi Sankyo, Merck, Novo Nordisk, and Pfizer; and consulting for Amryt/Chiesi, Alnylam, Amarin, Amgen, Applied Therapeutics, Ascendia, Biogen, Boehringer Ingelheim, Bristol Myers-Squibb, CSL Behring, Eli Lilly, Janssen, Lexicon, Merck, Milestone, Pfizer, Rhoshan, and Sanofi. Dr Wexler reports participating in the data monitoring committee for Novo Nordisk; and is Co-Investigator (Putman, Principal Investigator) of Vertex VX22-264-101 Study at the Diabetes Research Center. Dr Scirica reports research grants via Brigham and Women’s Hospital from Amgen, Better Therapeutics, Boehringer Ingelheim, Merck, NovoNordisk, and Pfizer; consulting for Abbvie (Data Safety Monitoring Board [DSMB]), AstraZeneca (DSMB), Bayer, Boehringer Ingelheim, Better Therapeutics, Bristol Myers-Squibb, Elsevier Practice Update Cardiology, Esperion, Hanmi (DSMB), Lexeo (DSMB), Lexicon, and NovoNordisk; and equity in Doximity and Health [at] Scale. The other authors report no disclosures.

Aim: Describe the rationale for and design of Diabetes Remote Intervention to improVe use of Evidence-based medications (DRIVE), a remote medication management program designed to initiate and titrate guideline-directed medical therapy (GDMT) in patients with type 2 diabetes (T2D) at elevated cardiovascular (CV) and/or kidney risk by leveraging non-physician providers., Methods: An electronic health record based algorithm is used to identify patients with T2D and either established atherosclerotic CV disease (ASCVD), high risk for ASCVD, chronic kidney disease, and/or heart failure within our health system. Patients are invited to participate and randomly assigned to either simultaneous education and medication management, or a period of education prior to medication management. Patient navigators (trained, non-licensed staff) are the primary points of contact while a pharmacist or nurse practitioner reviews and authorizes each medication initiation and titration under an institution-approved collaborative drug therapy management protocol with supervision from a cardiologist and/or endocrinologist. Patient engagement is managed through software to support communication, automation, workflow, and standardization., Conclusion: We are testing a remote, navigator-driven, pharmacist-led, and physician-overseen management strategy to optimize GDMT for T2D as a population-level strategy to close the gap between guidelines and clinical practice for patients with T2D at elevated CV and/or kidney risk., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: This project was funded by an unrestricted grant from Novo Nordisk to Brigham and Women’s Hospital., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Rates of depression and addiction have risen drastically over the past decade, but the lack of integrative techniques remains a barrier to accurate diagnoses of these mental illnesses. Changes in reward/aversion behavior and corresponding brain structures have been identified in those with major depressive disorder (MDD) and cocaine-dependence polysubstance abuse disorder (CD). Assessment of statistical interactions between computational behavior and brain structure may quantitatively segregate MDD and CD., Methods: Here, 111 participants [40 controls (CTRL), 25 MDD, 46 CD] underwent structural brain MRI and completed an operant keypress task to produce computational judgment metrics. Three analyses were performed: (1) linear regression to evaluate groupwise (CTRL v. MDD v. CD) differences in structure-behavior associations, (2) qualitative and quantitative heatmap assessment of structure-behavior association patterns, and (3) the k-nearest neighbor machine learning approach using brain structure and keypress variable inputs to discriminate groups., Results: This study yielded three primary findings. First, CTRL, MDD, and CD participants had distinct structure-behavior linear relationships, with only 7.8% of associations overlapping between any two groups. Second, the three groups had statistically distinct slopes and qualitatively distinct association patterns. Third, a machine learning approach could discriminate between CTRL and CD, but not MDD participants., Conclusions: These findings demonstrate that variable interactions between computational behavior and brain structure, and the patterns of these interactions, segregate MDD and CD. This work raises the hypothesis that analysis of interactions between operant tasks and structural neuroimaging might aide in the objective classification of MDD, CD and other mental health conditions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Vike et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)