Introduction The randomized, placebo-controlled, double-blind MOVe-OUT trial demonstrated molnupiravir (800 mg every 12 h for 5 days) as safe and effective for outpatient treatment of mild-to-moderate COVID-19, significantly reducing the risk of hospitalization/death in high-risk adults. At the time of that report, virologic assessments from the trial were partially incomplete as a result of their time-intensive nature. Here we present final results from all prespecified virology endpoints in MOVe-OUT based on the full trial dataset. Methods Nasopharyngeal swabs were collected at baseline (day 1, prior to first dose) and days 3, 5 (end-of-treatment visit), 10, 15, and 29. From these samples, change from baseline in SARS-CoV-2 RNA titers (determined by quantitative PCR), detection of infectious SARS-CoV-2 (by plaque assay), and SARS-CoV-2 viral error induction (determined by whole genome next-generation sequencing) were assessed as exploratory endpoints. Results Molnupiravir was associated with greater mean reductions from baseline in SARS-CoV-2 RNA than placebo (including 50% relative reduction at end-of-treatment) through day 10. Among participants with infectious virus detected at baseline (n = 96 molnupiravir, n = 97 placebo) and evaluable post-baseline samples, no molnupiravir-treated participant had infectious SARS-CoV-2 by day 3, whereas infectious virus was recovered from 21% of placebo-arm participants on day 3 and 2% at end-of-treatment. Consistent with molnupiravir’s mechanism of action, sequence analysis demonstrated that molnupiravir was associated with an increased number of low-frequency transition errors randomly distributed across the SARS-CoV-2 RNA genome compared with placebo (median 143.5 molnupiravir, 15 placebo), while transversion errors were infrequent overall (median 2 in both arms). Outcomes were consistent regardless of baseline SARS-CoV-2 clade, presence of SARS-CoV-2-specific immune response, or viral load. Conclusions A 5-day course of orally administered molnupiravir demonstrated a consistently greater virologic effect than placebo, including rapidly eliminating infectious SARS-CoV-2, in high-risk outpatients with mild-to-moderate COVID-19. Trial Registration ClinicalTrials.gov, NCT04575597.

Accountable Care Organizations (ACOs) seek sustainable innovation through the testing of new care delivery methods that promote shared goals among value-based health care collaborators. The Morehouse Choice Accountable Care Organization and Education System (MCACO-ES), or (M-ACO) is a physician led integrated delivery model participating in the Medicare Shared Savings Program (MSSP) offered through the Centers for Medicare and Medicaid Services (CMS) Innovation Center. The MSSP establishes incentivized, performance-based payment models for qualifying health care organizations serving traditional Medicare beneficiaries that promote collaborative efficiency models designed to mitigate fragmented and insufficient access to health care, reduce unnecessary cost, and improve clinical outcomes. The M-ACO integration model is administered through participant organizations that include a multi-site community based academic practice, independent physician practices, and federally qualified health center systems (FQHCs). This manuscript aims to present a descriptive and exploratory assessment of health care programs and related innovation methods that validate M-ACO as a reliable simulator to implement, evaluate, and refine M-ACO’s integration model to render value-based performance outcomes over time. A part of the research approach also includes early outcomes and lessons learned advancing the framework for ongoing testing of M-ACO’s integration model across independently owned, rural, and urban health care locations that predominantly serve low-income, traditional Medicare beneficiaries, (including those who also qualify for Medicaid benefits (also referred to as “dual eligibles”). M-ACO seeks to determine how integration potentially impacts targeted performance results. As a simulator to test value-based innovation and related clinical and business practices, M-ACO uses enterprise-level data and advanced analytics to measure certain areas, including: 1) health program insight and effectiveness; 2) optimal implementation process and workflows that align primary care with specialists to expand access to care; 3) chronic care management/coordination deployment as an effective extender service to physicians and patients risk stratified based on defined clinical and social determinant criteria; 4) adoption of technology tools for patient outreach and engagement, including a mobile application for remote biometric monitoring and telemedicine; and 5) use of structured communication platforms that enable practitioner engagement and ongoing training regarding the shift from volume to value-based care delivery.

Background: A critical unmet need for underserved patients with diabetes is regular access to sufficient support for diabetes self-management. Although advances in digital technologies have made way for eHealth applications that provide a scalable path for tailored interventions for self-management of chronic conditions, health and digital literacy has remained an obstacle to leveraging these technologies for effective diabetes self-management education. Studies have shown that the availability of coaches helps to maintain engagement in internet-based studies and improves self-efficacy for behavior change. However, little is known about the substances involved in these interactions. Objective: This study aims to compare the content of conversations between patient–coach pairs that achieved their self-management goals and those that did not. The context is a clinical implementation study of diabetes self-management behavior change using Health360x within the practices of the Morehouse Choice Accountable Care Organization in the Atlanta metro area. Health360x is a coach-assisted consumer health information technology designed to support self-management skills acquisition and behavior among underserved, high-risk patients with diabetes. Methods: We provide a novel analysis of the discursive emphasis on patients and coaches. We examined transcripts of visits using a structural topic model to estimate topic content and prevalence as a function of patient and coach characteristics. We compared topics between patient–coach pairs that achieved diabetes-related self-management goals and those who did not. We also estimated a regression in which utterances are the units, the dependent variable is the proportion of an utterance that is about a given topic, and the independent variables are speaker types and explored other themes. Results: Transcripts from 50 patients who were recruited and consented, starting in February 2015, were analyzed. A total of 44 topics were estimated for patient–coach pairs that achieved their intended health goals and 50 topics for those who did not. Analysis of the structural topic model results indicated that coaches in patient–coach pairs that were able to achieve self-management goals provided more contextual feedback and probed into patients’ experience with technology and trust in consumer information technologies. We also found that discussions around problem areas and stress, support (βCoach=.015; P<.001), initial visits (βCoach=.02; P<.001), problems with technology (βCoach=.01; P<.001), health eating goals (βCoach=.01; P=.04), diabetes knowledge (βCoach=.02; P<.001), managing blood sugar (βCoach=.03; P<.001), and using Health360x (βCoach=.003; P=.03) were dominated by coaches. Conclusions: Coach-facilitated, technology-based diabetes self-management education can help underserved patients with diabetes. Our use of topic modeling in this application sheds light on the actual dynamics in conversations between patients and coaches. Knowledge of the key elements for successful coach–patient interactions based on the analysis of transcripts could be applied to understanding everyday patient–provider encounters, given the recent paradigm shift around the use of telehealth.

Background. This paper reports on the implementation and evaluation of a strategy to promote collaborations and team science among investigators at the Research Centers in Minority Institutions (RCMI). The strategy presented in this paper was a hands-on workshop that allowed the application of strategic team science through structured dialogue, asset sharing, and systematic exploration of opportunities for collaboration. Methods. The workshop was attended by more than 100 participants, including RCMI and non-RCMI investigators, practice-based research network (PBRN) supplement program directors, and an NIH Institute on Minority Health and Health Disparities Program Officer. Results. A post-workshop survey was administered to collect participant feedback, assess the relevance of the workshop to the participants’ professional development goals, and gauge the applicability of the tool as a support strategy to promote collaborative research. Most of the participants acknowledged that the session met the conference objectives (95.8%), and 93.7% noted that the workshop, to a high degree, met their personal goals and objectives. During the workshop, participants shared 35 resources they were willing and able to offer for prospective collaborative projects. Conclusion. The experience reported and evaluated in this paper paves the way to understanding methods for disseminating effective strategies for inter-institutional collaborations for the sustainable growth and operation of PBRNs.

BACKGROUND A critical unmet need for underserved patients with diabetes is regular access to sufficient support for diabetes self-management. Although advances in digital technologies have made way for eHealth applications that provide a scalable path for tailored interventions for self-management of chronic conditions, health and digital literacy has remained an obstacle to leveraging these technologies for effective diabetes self-management education. Studies have shown that the availability of coaches helps to maintain engagement in internet-based studies and improves self-efficacy for behavior change. However, little is known about the substances involved in these interactions. OBJECTIVE This study aims to compare the content of conversations between patient–coach pairs that achieved their self-management goals and those that did not. The context is a clinical implementation study of diabetes self-management behavior change using Health360x within the practices of the Morehouse Choice Accountable Care Organization in the Atlanta metro area. Health360x is a coach-assisted consumer health information technology designed to support self-management skills acquisition and behavior among underserved, high-risk patients with diabetes. METHODS We provide a novel analysis of the discursive emphasis on patients and coaches. We examined transcripts of visits using a structural topic model to estimate topic content and prevalence as a function of patient and coach characteristics. We compared topics between patient–coach pairs that achieved diabetes-related self-management goals and those who did not. We also estimated a regression in which utterances are the units, the dependent variable is the proportion of an utterance that is about a given topic, and the independent variables are speaker types and explored other themes. RESULTS Transcripts from 50 patients who were recruited and consented, starting in February 2015, were analyzed. A total of 44 topics were estimated for patient–coach pairs that achieved their intended health goals and 50 topics for those who did not. Analysis of the structural topic model results indicated that coaches in patient–coach pairs that were able to achieve self-management goals provided more contextual feedback and probed into patients’ experience with technology and trust in consumer information technologies. We also found that discussions around problem areas and stress, support (βCoach=.015; P<.001), initial visits (βCoach=.02; P<.001), problems with technology (βCoach=.01; P<.001), health eating goals (βCoach=.01; P=.04), diabetes knowledge (βCoach=.02; P<.001), managing blood sugar (βCoach=.03; P<.001), and using Health360x (βCoach=.003; P=.03) were dominated by coaches. CONCLUSIONS Coach-facilitated, technology-based diabetes self-management education can help underserved patients with diabetes. Our use of topic modeling in this application sheds light on the actual dynamics in conversations between patients and coaches. Knowledge of the key elements for successful coach–patient interactions based on the analysis of transcripts could be applied to understanding everyday patient–provider encounters, given the recent paradigm shift around the use of telehealth.