Enhancing Success of Medicare\u27s Shared Decision Making Mandates Using Implementation Science: Examples Applying the Pragmatic Robust Implementation and Sustainability Model (PRISM)

The Centers for Medicare and Medicaid Services (CMS) has mandated shared decision making (SDM) using patient decision aids for three conditions (lung cancer screening, atrial fibrillation, and implantable defibrillators). These forward-thinking approaches are in response to a wealth of efficacy data demonstrating that decision aids can improve patient decision making. However, there has been little focus on how to implement these approaches in real-world practice. This article demonstrates how using an implementation science framework may help programs understand multilevel challenges and opportunities to improve adherence to the CMS mandates. Using the PRISM (Pragmatic Robust Implementation and Sustainability Model) framework, we discuss general challenges to implementation of SDM, issues specific to each mandate, and how to plan for, enhance, and assess SDM implementation outcomes. Notably, a theme of this discussion is that successful implementation is context-specific and to truly have successful and sustainable changes in practice, context variability, and adaptation to context must be considered and addressed

Electronic Health Record Portal Messages and Interactive Voice Response Calls to Improve Rates of Early Season Influenza Vaccination: Randomized Controlled Trial

BACKGROUND: Patient reminders for influenza vaccination, delivered via an electronic health record patient portal and interactive voice response calls, offer an innovative approach to engaging patients and improving patient care. OBJECTIVE: The goal of this study was to test the effectiveness of portal and interactive voice response outreach in improving rates of influenza vaccination by targeting patients in early September, shortly after vaccinations became available. METHODS: Using electronic health record portal messages and interactive voice response calls promoting influenza vaccination, outreach was conducted in September 2015. Participants included adult patients within a large multispecialty group practice in central Massachusetts. Our main outcome was electronic health record-documented early influenza vaccination during the 2015-2016 influenza season, measured in November 2015. We randomly assigned all active portal users to 1 of 2 groups: (1) receiving a portal message promoting influenza vaccinations, listing upcoming clinics, and offering online scheduling of vaccination appointments (n=19,506) or (2) receiving usual care (n=19,505). We randomly assigned all portal nonusers to 1 of 2 groups: (1) receiving interactive voice response call (n=15,000) or (2) receiving usual care (n=43,596). The intervention also solicited patient self-reports on influenza vaccinations completed outside the clinic. Self-reported influenza vaccination data were uploaded into the electronic health records to increase the accuracy of existing provider-directed electronic health record clinical decision support (vaccination alerts) but were excluded from main analyses. RESULTS: Among portal users, 28.4% (5549/19,506) of those randomized to receive messages and 27.1% (5294/19,505) of the usual care group had influenza vaccinations documented by November 2015 (P=.004). In multivariate analysis of portal users, message recipients were slightly more likely to have documented vaccinations when compared to the usual care group (OR 1.07, 95% CI 1.02-1.12). Among portal nonusers, 8.4% (1262/15,000) of those randomized to receive calls and 8.2% (3586/43,596) of usual care had documented vaccinations (P=.47), and multivariate analysis showed nonsignificant differences. Over half of portal messages sent were opened (10,112/19,479; 51.9%), and over half of interactive voice response calls placed (7599/14,984; 50.7%) reached their intended target, thus we attained similar levels of exposure to the messaging for both interventions. Among portal message recipients, 25.4% of message openers (2570/10,112) responded to a subsequent question on receipt of influenza vaccination; among interactive voice response recipients, 72.5% of those reached (5513/7599) responded to a similar question. CONCLUSIONS: Portal message outreach to a general primary care population achieved a small but statistically significant improvement in rates of influenza vaccination (OR 1.07, 95% CI 1.02-1.12). Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10). Rates of patient engagement with both modalities were favorable. TRIAL REGISTRATION: ClinicalTrials.gov NCT02266277; https://clinicaltrials.gov/ct2/show/NCT02266277. Lloyd Fisher, Peggy Preusse, Devi Sundaresan, Lawrence Garber, Kathleen M Mazor, Sarah L Cutrona. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 25.09.2020

Written Advice Given by African American Smokers to Their Peers: Qualitative Study of Motivational Messages

BACKGROUND: Although African Americans have the lowest rates of smoking onset and progression to daily smoking, they are less likely to achieve long-term cessation. Interventions tailored to promote use of cessation resources in African American individuals who smoke are needed. In our past work, we demonstrated the effectiveness of a technology-assisted peer-written message intervention for increasing smoking cessation in non-Hispanic White smokers. In this formative study, we have adapted this intervention to be specific for African American smokers. OBJECTIVE: We aimed to report on the qualitative analysis of messages written by African American current and former smokers for their peers in response to hypothetical scenarios of smokers facing cessation challenges. METHODS: We recruited African American adult current and former smokers (n=41) via ResearchMatch between April 2017 and November 2017. We asked participants to write motivational messages for their peers in response to smoking-related hypothetical scenarios. We also collected data on sociodemographic factors and smoking characteristics. Thematic analysis was conducted to identify cessation strategies suggested by the study participants. RESULTS: Among the study participants, 60% (25/41) were female. Additionally, more than half (23/41, 56%) were thinking about quitting, 29% (12/41) had set a quit date, and 27% (11/41) had used electronic cigarettes in the past 30 days. Themes derived from the qualitative analysis of peer-written messages were (1) behavioral strategies, (2) seeking help, (3) improvements in quality of life, (4) attitudes and expectations, and (5) mindfulness/religious or spiritual practices. Under the behavioral strategies theme, distraction strategies were the most frequently suggested strategies (referenced 84 times in the 318 messages), followed by use of evidence-based treatments/cessation strategies. Within the seeking help theme, subthemes included seeking help or support from family/friends or close social networks (referenced 56 times) and health care professionals (referenced 22 times). The most frequent subthemes that emerged from improvements in the quality of life theme included improving one\u27s health (referenced 22 times) and quality of life (referenced 21 times). Subthemes that emerged from the attitude and expectations theme included practicing positive self-talk (referenced 27 times), autonomy/independence from the smoking habit (referenced six times), and financial cost of smoking (referenced five times). The two subthemes that emerged from the mindfulness/religious or spiritual practices theme were use of self-awareness techniques (referenced 36 times) and religious or spiritual practices to cope (referenced 13 times). CONCLUSIONS: Our approach to adapt a prior peer-message intervention to African American smokers yielded a set of evidence-based messages that may be suitable for smokers at all phases of motivation to quit (ready to quit or not ready to quit). In future research, we plan to assess the impact of texting these messages to African American smokers in a smoking cessation trial. H Williams, Dalton Mourao, Oluwabunmi M Emidio, Maryann Davis, Lori Pbert, Sarah L Cutrona, Thomas K Houston, Rajani S Sadasivam. Originally published in JMIR Formative Research (https://formative.jmir.org), 30.04.2021

The whole blood transcriptional regulation landscape in 465 COVID-19 infected samples from Japan COVID-19 Task Force

「コロナ制圧タスクフォース」COVID-19患者由来の血液細胞における遺伝子発現の網羅的解析 --重症度に応じた遺伝子発現の変化には、ヒトゲノム配列の個人差が影響する--. 京都大学プレスリリース. 2022-08-23.Coronavirus disease 2019 (COVID-19) is a recently-emerged infectious disease that has caused millions of deaths, where comprehensive understanding of disease mechanisms is still unestablished. In particular, studies of gene expression dynamics and regulation landscape in COVID-19 infected individuals are limited. Here, we report on a thorough analysis of whole blood RNA-seq data from 465 genotyped samples from the Japan COVID-19 Task Force, including 359 severe and 106 non-severe COVID-19 cases. We discover 1169 putative causal expression quantitative trait loci (eQTLs) including 34 possible colocalizations with biobank fine-mapping results of hematopoietic traits in a Japanese population, 1549 putative causal splice QTLs (sQTLs; e.g. two independent sQTLs at TOR1AIP1), as well as biologically interpretable trans-eQTL examples (e.g., REST and STING1), all fine-mapped at single variant resolution. We perform differential gene expression analysis to elucidate 198 genes with increased expression in severe COVID-19 cases and enriched for innate immune-related functions. Finally, we evaluate the limited but non-zero effect of COVID-19 phenotype on eQTL discovery, and highlight the presence of COVID-19 severity-interaction eQTLs (ieQTLs; e.g., CLEC4C and MYBL2). Our study provides a comprehensive catalog of whole blood regulatory variants in Japanese, as well as a reference for transcriptional landscapes in response to COVID-19 infection

DOCK2 is involved in the host genetics and biology of severe COVID-19

「コロナ制圧タスクフォース」COVID-19疾患感受性遺伝子DOCK2の重症化機序を解明 --アジア最大のバイオレポジトリーでCOVID-19の治療標的を発見--. 京都大学プレスリリース. 2022-08-10.Identifying the host genetic factors underlying severe COVID-19 is an emerging challenge. Here we conducted a genome-wide association study (GWAS) involving 2, 393 cases of COVID-19 in a cohort of Japanese individuals collected during the initial waves of the pandemic, with 3, 289 unaffected controls. We identified a variant on chromosome 5 at 5q35 (rs60200309-A), close to the dedicator of cytokinesis 2 gene (DOCK2), which was associated with severe COVID-19 in patients less than 65 years of age. This risk allele was prevalent in East Asian individuals but rare in Europeans, highlighting the value of genome-wide association studies in non-European populations. RNA-sequencing analysis of 473 bulk peripheral blood samples identified decreased expression of DOCK2 associated with the risk allele in these younger patients. DOCK2 expression was suppressed in patients with severe cases of COVID-19. Single-cell RNA-sequencing analysis (n = 61 individuals) identified cell-type-specific downregulation of DOCK2 and a COVID-19-specific decreasing effect of the risk allele on DOCK2 expression in non-classical monocytes. Immunohistochemistry of lung specimens from patients with severe COVID-19 pneumonia showed suppressed DOCK2 expression. Moreover, inhibition of DOCK2 function with CPYPP increased the severity of pneumonia in a Syrian hamster model of SARS-CoV-2 infection, characterized by weight loss, lung oedema, enhanced viral loads, impaired macrophage recruitment and dysregulated type I interferon responses. We conclude that DOCK2 has an important role in the host immune response to SARS-CoV-2 infection and the development of severe COVID-19, and could be further explored as a potential biomarker and/or therapeutic target

Empowering Patients for Shared Decision Making in Lung Cancer Screening via Text Messages

Background: Shared decision-making (SDM) counseling for lung cancer screening is recommended by multiple professional societies and mandated by the Center for Medicare and Medicaid Services since lung cancer screening has both benefits and risks. However, uptake of SDM counseling as well as lung cancer screening itself remain low. We sought to develop educational text messages about lung cancer screening as an innovative implementation intervention tool to promote patient-provider discussion about lung cancer screening. Methods: After the study team drafted educational text messages about lung cancer screening, informed by existing decision aids, participants who had had lung cancer screening were recruited and asked to review and edit text messages. After that, participants eligible for lung cancer screening without the previous screening experience were recruited and were asked to select the messages to be included in this text message intervention. The final set of 14 text messages were delivered to the participants both with and without the previous lung cancer screening over a period of 14 days. Participants completed a telephone survey assessing their reactions to the messages after receiving the last message. Results: We successfully involved twelve participants with lung cancer screening experience and eleven lung cancer screening eligible participants without previous screening experience in the development of educational text messages about lung cancer screening. After one participant withdrew, 22 participants received text messages and completed the survey regarding the messages. Most participants (18 of 22) reported reading all 14 text messages, however most recommended sending fewer messages (median recommended number of messages = 10). Participants found the educational text messages informative. Only four participants reported the text messages triggered anxiety and two reported text messages disrupted their daily activities. Participants perceived the text messages would empower patients to discuss lung cancer screening with their providers. Conclusion: Participants generally supported the use of educational text messages about lung cancer screening to increase patients’ awareness and promote patient-provider discussion. Engaging patients in the development and evaluation of text messages elicited helpful feedback that will inform the content of the messages to be delivered via this lung cancer screening text messages intervention

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening

The Centers for Medicare and Medicaid Services has mandated in-person shared decision-making (SDM) counseling with the use of one or more decision aids (DAs) prior to lung cancer screening. We developed a single-page, paper-based, encounter DA (EDA) to be used within a clinician-patient encounter for lung cancer screening and conducted a pre-post pilot intervention study to evaluate its feasibility and effects on patient decisional conflict. Patients referred to a pulmonary practice-based lung cancer screening program were surveyed before and after an SDM visit with a pulmonologist, who used the EDA to counsel the patient. Patient knowledge of the mortality benefit from screening and the frequency of abnormal screening test results was evaluated after the visit, while decisional conflict was measured before and after the visit using the Decisional Conflict Scale (DCS). Twenty-three patients participated (mean age = 65.8 years; 43% female; mean smoking history = 57.8 pack-years; 48% currently smoking). Following the visit, 28% of participants correctly understood the mortality benefit of lung cancer screening, while 82% understood the frequency of abnormal screening tests. The mean total DCS score decreased from 35.0 to 0.2 after the visit (p \u3c 0.001). These data suggest that a single-page, paper-based EDA is feasible and potentially effective in reducing decision conflict when used within a SDM visit, although more research is needed to establish the independent effects of the EDA, and future efforts to promote SDM may need to devote greater attention to improving patient understanding of the mortality benefit of screening

Characterizing pandemic-related changes in smoking over time in a cohort of current and former smokers

INTRODUCTION: We used a longitudinal cohort of U.S. adults who were current or former smokers to explore how three participant-reported factors - general stress, COVID-19 distress, and perceived risk of complications from COVID-19 related to smoking - were associated with changes in smoking status. METHODS: Smoking status was assessed at three time points. Timepoint 1 status was assessed at a prior study completion (2018-2020). Timepoint 2 (start of the pandemic) and Timepoint 3 (early phase of the pandemic) statuses were assessed using an additional survey in 2020. After classifying participants into eight groups per these time points, we compared the means of participant-reported factors and used a linear regression model to adjust for covariates. RESULTS: Participants (n=392) were mostly female (73.9%) and non-Hispanic White (70.1%). Between Timepoints 2 and 3, abstinence rates decreased by 11%, and 40% of participants reported a smoking status change. Among those reporting a change and the highest general stress levels, newly abstinent participants had higher perceived risk of complications from COVID-19 related to smoking than those who relapsed during pandemic (mean (standard deviation): 14.2 (3.3) vs. 12.6 (3.8)). Compared to participants who sustained smoking, those who sustained abstinence, on average, scored 1.94 less on the general stress scale (betaeta Coefficient (beta): -1.94, p-value \u3c 0.01) and 1.37 less on the perceived risk of complications from COVID-19 related to smoking scale (beta: -1.37, p-value 0.02). CONCLUSIONS: Decreased abstinence rates are concerning. Patterns of reported factors were as expected for individuals who sustained their smoking behavior but not for those who changed. IMPLICATIONS: We observed an increase in smoking rates during the COVID-19 pandemic. In exploring how combinations of general stress levels, COVID-19 distress levels, and perceived risk of complications from COVID-19 related to smoking were associated with changes in smoking, we observed expected patterns of these factors among individuals who sustained abstinence or smoking. Among individuals who changed smoking status and reported high stress levels, those who reported a higher perceived risk of complications from COVID-19 related to smoking abstained from smoking. In contrast, those who reported a lower perceived risk of complications from COVID-19 related to smoking, started smoking. An intersectional perspective may be needed to understand smokers\u27 pandemic-related behavior changes