Search

Abstract Background Mesenchymal stem cells (MSCs) attenuate lung injury in experimental models of bronchopulmonary dysplasia (BPD). Stromal derived factor-1 (SDF-1), a chemokine secreted by MSCs, modulates angiogenesis and stem cell recruitment. Here we tested the hypothesis that SDF-1 mediates MSC protective effects in experimental BPD by modulating angiogenesis. Methods SDF-1 was knocked down in MSCs using lentiviral vectors carrying anti-SDF-1 short hairpin RNA (MSC-SDF KD). Non-silencing short hairpin RNA was used as control (MSC-NS control). Newborn rats exposed to normoxia or hyperoxia (FiO2 = 0.85) for 3 weeks, were randomly assigned to receive a single intra-tracheal injection (IT) of MSC-NS control or MSC-SDF KD (1 × 106 cells/50 μl) or placebo on postnatal day 7. The degree of alveolarization, lung angiogenesis, inflammation, and pulmonary hypertension (PH) were assessed at postnatal day 21. Results Administration of IT MSC-NS control improved lung alveolarization, angiogenesis and inflammation, and attenuated PH in newborn rats with hyperoxia-induced lung injury (HILI). In contrast, knockdown of SDF-1 in MSCs significantly reduced their beneficial effects on alveolarization, angiogenesis, inflammation and PH. Conclusions The therapeutic benefits of MSCs in neonatal HILI are in part mediated by SDF-1, through anti-inflammatory and angiogenesis promoting mechanisms. Therapies directly targeting this chemokine may provide a novel strategy for the treatment of BPD.

Recent studies suggest that bone marrow (BM)-derived stem cells have therapeutic efficacy in neonatal hyperoxia-induced lung injury (HILI). c-kit, a tyrosine kinase receptor that regulates angiogenesis, is expressed on several populations of BM-derived cells. Preterm infants exposed to hyperoxia have decreased lung angiogenesis. Here we tested the hypothesis that administration of BM-derived c-kit + cells would improve angiogenesis in neonatal rats with HILI. To determine whether intratracheal (IT) administration of BM-derived c-kit + cells attenuates neonatal HILI, rat pups exposed to either normobaric normoxia (21% O 2 ) or hyperoxia (90% O 2 ) from postnatal day (P) 2 to P15 were randomly assigned to receive either IT BM-derived green fluorescent protein (GFP) + c-kit – cells (PL) or BM-derived GFP + c-kit + cells on P8. The effect of cell therapy on lung angiogenesis, alveolarization, pulmonary hypertension, vascular remodeling, cell proliferation, and apoptosis was determined at P15. Cell engraftment was determined by GFP immunostaining. Compared to PL, the IT administration of BM-derived c-kit + cells to neonatal rodents with HILI improved alveolarization as evidenced by increased lung septation and decreased mean linear intercept. This was accompanied by an increase in lung vascular density, a decrease in lung apoptosis, and an increase in the secretion of proangiogenic factors. There was no difference in pulmonary vascular remodeling or the degree of pulmonary hypertension. Confocal microscopy demonstrated that 1% of total lung cells were GFP + cells. IT administration of BM-derived c-kit + cells improves lung alveolarization and angiogenesis in neonatal HILI, and this may be secondary to an improvement in the lung angiogenic milieu.

Background: There are well-established guidelines for treating hypertension (HTN), yet only half of patients with HTN meet the defined target of < 140/90. Team-based care (TBC) is an evidence-based strategy for improving blood pressure (BP) management and control. TBC is defined as the provision of health services by at least two health professionals "who work collaboratively with patients and their caregivers to accomplish shared goals to achieve coordinated, high-quality care". However, primary care practices experience challenges to implementing TBC principles and care processes; these are more pronounced in small independent practice settings (SIPs). Practice facilitation (PF) is an implementation strategy that may overcome barriers to adopting evidence-based TBC to improve HTN management in SIPs., Methods: Using a stepped wedge randomized controlled trial design, we will test the effect of PF on the adoption of TBC to improve HTN management in small practices (< 5 FTE clinicians) in New York City, and the impact on BP control compared with usual care. We will enroll 90 SIPs and randomize them into one of three 12-month intervention waves. Practice facilitators will support SIPs to adopt TBC principles to improve implementation of five HTN management strategies (i.e., panel management, population health, measuring BP, supporting medication adherence, self-management). The primary outcome is the adoption of TBC for HTN management measured at baseline and 12 months. Secondary outcomes include the rate of BP control and sustainability of TBC and BP outcomes at 18 months. Aggregated data on BP measures are collected every 6 months in all clusters so that each cluster provides data points in both the control and intervention conditions. Using a mixed methods approach, we will also explore factors that influence the effectiveness of PF at the organization and team level., Discussion: This study will provide much-needed guidance on how to optimize adoption and sustainability of TBC in independent primary care settings to reduce the burden of disease related to suboptimal BP control and advance understanding of how facilitation works to improve implementation of evidence-based interventions., Trial Registration: ClinicalTrials.gov; NCT05413252 ., (© 2023. The Author(s).)

Background: Guidelines for managing and preventing chronic disease tend to be well-known. Yet, translation of this evidence into practice is inconsistent. We identify a combination of factors that are connected to guideline concordant delivery of evidence-informed chronic disease care in primary care., Methods: Cross-sectional observational study; purposively selected 22 practices to vary on size, ownership and geographic location, using National Quality Forum metrics to ensure practices had a ≥ 70% quality level for at least 2 of the following: aspirin use in high-risk individuals, blood pressure control, cholesterol and diabetes management. Interviewed 2 professionals (eg, medical director, practice manager) per practice (n = 44) to understand staffing and clinical operations. Analyzed data using an iterative and inductive approach., Results: Community Health Centers (CHCs) employed interdisciplinary clinical teams that included a variety of professionals as compared with hospital-health systems (HHS) and clinician-owned practices. Despite this difference, practice members consistently reported a number of functions that may be connected to clinical chronic care quality, including: having engaged leadership; a culture of teamwork; engaging in team-based care; using data to inform quality improvement; empaneling patients; and managing the care of patient panels, with a focus on continuity and comprehensiveness, as well as having a commitment to the community., Conclusions: There are mutable organizational attributes connected-guideline concordant chronic disease care in primary care. Research and policy reform are needed to promote and study how to achieve widespread adoption of these functions and organizational attributes that may be central to achieving equity and improving chronic disease prevention., Competing Interests: Conflict of interest: The authors report no competing or conflicting interests., (© Copyright by the American Board of Family Medicine.)

Background: Studies specifically focused on patients' perspectives on telemedicine visits in primary and behavioral health care are fairly limited and have often focused on highly selected populations or used overall satisfaction surveys., Objective: To examine patient perspectives on the shift to telemedicine, the remote delivery of health care via the use of electronic information and communications technology, in primary and behavioral health care in Federally Qualified Health Centers (FQHCs) during COVID-19., Design: Semi-structured interviews were conducted using video conference with patients and caregivers between October and December 2020., Participants: Providers from 6 FQHCs nominated participants. Eighteen patients and caregivers were interviewed: 6 patients with only primary care visits; 5 with only behavioral health visits; 3 with both primary care and behavioral health visits; and 4 caregivers of children with pediatric visits., Approach: Using a protocol-driven, rapid qualitative methodology, we analyzed the interview data and assessed the quality of care, benefits and challenges of telemedicine, and use of telemedicine post-pandemic., Key Results: Respondents broadly supported the option of home-based synchronous telemedicine visits in primary and behavioral health care. Nearly all respondents appreciated remote visits, largely because such visits provided a safe option during the pandemic. Patients were generally satisfied with telemedicine and believed the quality of visits to be similar to in-person visits, especially when delivered by a provider with whom they had established rapport. Although most respondents planned to return to mostly in-person visits when considered safe to do so, they remained supportive of the continued option for remote visits as remote care addresses some of the typical barriers faced by low-income patients., Conclusions: Addressing digital literacy challenges, enhancing remote visit privacy, and improving practice workflows will help ensure equitable access to all patients as we move to a new post-COVID-19 "normal" marked by increased reliance on telemedicine and technology., (© 2022. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Background: There is widespread agreement that the integration of cessation services in lung cancer screening (LCS) is essential for achieving the full benefits of LCS with low-dose computed tomography (LDCT). There is a formidable knowledge gap about how to best design feasible, effective, and scalable cessation services in LCS facilities. A collective of NCI-funded clinical trials addressing this gap is the Smoking Cessation at Lung Examination (SCALE) Collaboration., Methods: The Cessation and Screening to Save Lives (CASTL) trial seeks to advance knowledge about the reach, effectiveness, and implementation of tobacco treatment in lung cancer screening. We describe the rationale, design, evaluation plan, and interventions tested in this multiphase optimization strategy trial (MOST). A total of 1152 screening-eligible current smokers are being recruited from 18 LCS sites (n = 64/site) in both academic and community settings across the USA. Participants receive enhanced standard care (cessation advice and referral to the national Quitline) and are randomized to receive additional tobacco treatment components (motivational counseling, nicotine replacement patches/lozenges, message framing). The primary outcome is biochemically validated, abstinence at 6 months follow-up. Secondary outcomes are self-reported smoking abstinence, quit attempts, and smoking reduction at 3 and 6 months. Guided by the Implementation Outcomes Framework (IOF), our evaluation includes measurement of implementation processes (reach, fidelity, acceptability, appropriateness, sustainability, and cost)., Conclusion: We will identify effective treatment components for delivery by LCS sites. The findings will guide the assembly of an optimized smoking cessation package that achieves superior cessation outcomes. Future trials can examine the strategies for wider implementation of tobacco treatment in LDCT-LCS sites., Trial Registration: ClinicalTrials.gov NCT03315910., (© 2022. The Author(s).)

Purpose: Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings., Methods: The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design., Results: All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends., Conclusions: The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection. VISUAL ABSTRACT ., (© 2022 Annals of Family Medicine, Inc.)

Structures (context of care delivery) and processes (actions aimed at delivery care) are posited to drive patient outcomes. Despite decades of primary care research, there remains a lack of evidence connecting specific structures/processes to patient outcomes to determine which of the numerous recommended structures/processes to prioritize for implementation. The objective of this study was to identify structures/processes most commonly present in high-performing primary care practices for chronic care management and prevention. We conducted key informant interviews with a national sample of 22 high-performing primary care practices. We identified the 10 most commonly present structures/processes in these practices, which largely enable 2 core functions: mobilizing staff to conduct patient outreach and helping practices avoid gaps in care. Given the costs of implementing and maintaining numerous structures/processes, our study provides a starting list for providers to prioritize and for researchers to investigate further for specific effects on patient outcomes., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc.)

Background: Primary care practices have remained on the frontline of health care service delivery throughout the COVID-19 pandemic. The purpose of our study was to understand the early pandemic experience of primary care practices, how they adapted care processes for chronic disease management and preventive care, and the future potential of these practices' service delivery adaptations., Methods: We interviewed 44 providers and staff at 22 high-performing primary care practices located throughout the United States between March and May 2020. Interviews were transcribed and coded using a modified rapid assessment process due to the time-sensitive nature of the study., Results: Practices reported employing a variety of adaptations to care during the COVID-19 pandemic including maintaining safe and socially distanced access through increased use of telehealth visits, using disease registries to identify and proactively outreach to patients, providing remote patient education, and incorporating more home-based monitoring into care. Routine screening and testing slowed considerably, resulting in concerns about delayed detection. Patients with fewer resources, lower health literacy, and older adults were the most difficult to reach and manage during this time., Conclusion: Our findings indicate that primary care structures and processes developed for remote chronic disease management and preventive care are evolving rapidly. Emerging adapted care processes, most notably remote provision of care, are promising and may endure beyond the pandemic, but issues of equity must be addressed (e.g., through payment reform) to ensure vulnerable populations receive the same benefit., (© 2021. The Author(s).)

Background: Text message (ie, short message service, SMS) smoking cessation interventions have demonstrated efficacy in high-income countries but are less well studied in low- and middle-income countries, including Vietnam., Objective: The goal of the research is to assess the feasibility, acceptability, and preliminary efficacy of a fully automated bidirectional SMS cessation intervention adapted for Vietnamese smokers., Methods: The study was conducted in 3 phases. In phase 1, we adapted the SMS library from US-based SMS cessation programs (ie, SmokefreeTXT and Text2Quit). The adaptation process consisted of 7 focus groups with 58 smokers to provide data on culturally relevant patterns of tobacco use and assess message preferences. In phase 2, we conducted a single-arm pilot test of the SMS intervention with 40 smokers followed by in-depth interviews with 10 participants to inform additional changes to the SMS library. In phase 3, we conducted a 2-arm pilot randomized controlled trial (RCT) with 100 smokers. Participants received either the SMS program (intervention; n=50) or weekly text assessment on smoking status (control; n=50). The 6-week SMS program consisted of a 2-week prequit period and a 4-week postquit period. Participants received 2 to 4 automated messages per day. The main outcomes were engagement and acceptability which were assessed at 6 weeks (end of intervention). We assessed biochemically confirmed smoking abstinence at 6 weeks and 12 weeks. Postintervention in-depth interviews explored user experiences among a random sample of 16 participants in the intervention arm., Results: Participants in both arms reported high levels of engagement and acceptability. Participants reported using the program for an average of 36.4 (SD 3.4) days for the intervention arm and 36.0 (SD 3.9) days for the control arm. Four of the 50 participants in the intervention arm (8%) reset the quit date and 19 (38%) texted the keyword TIPS. The majority of participants in both arms reported that they always or usually read the text messages. Compared to the control arm, a higher proportion of participants in the intervention arm reported being satisfied with the program (98% [49/50] vs 82% [41/50]). Biochemically verified abstinence was higher in the intervention arm at 6 weeks (20% [10/50] vs 2% [1/50]; P=.01), but the effect was not significant at 12 weeks (12% [6/50] vs 6% [3/50]; P=.49). In-depth interviews conducted after the RCT suggested additional modifications to enhance the program including tailoring the timing of messages, adding more opportunities to interact with the program, and placing a greater emphasis on messages that described the harms of smoking., Conclusions: The study supported the feasibility and acceptability of an SMS program adapted for Vietnamese smokers. Future studies need to assess whether, with additional modifications, the program is associated with prolonged abstinence., Trial Registration: ClinicalTrials.gov NCT03219541; https://clinicaltrials.gov/ct2/show/NCT03219541., (©Nan Jiang, Nam Nguyen, Nina Siman, Charles M Cleland, Trang Nguyen, Hue Thi Doan, Lorien C Abroms, Donna R Shelley. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 08.10.2021.)

Few studies have assessed the fidelity of practice facilitation (PF) as an implementation strategy, and none have used an a priori definition or conceptual framework of fidelity to guide fidelity assessment. The authors adapted the Conceptual Framework for Implementation Fidelity to guide fidelity assessment in HealthyHearts NYC, an intervention that used PF to improve adoption of cardiovascular disease evidence-based guidelines in primary care practices. Data from a web-based tracking system of 257 practices measured fidelity using 4 categories: frequency, duration, content, and coverage. Almost all (94.2%) practices received at least the required 13 PF visits. Facilitators spent on average 26.3 hours at each site. Most practices (95.7%) completed all Task List items, and 71.2% were educated on all Chronic Care Model strategies. The majority (65.8%) received full coverage. This study provides a model that practice managers and implementers can use to evaluate fidelity of PF, and potentially other implementation strategies., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Policy Points Telehealth has many potential advantages during an infectious disease outbreak such as the COVID-19 pandemic, and the COVID-19 pandemic has accelerated the shift to telehealth as a prominent care delivery mode. Not all health care providers and patients are equally ready to take part in the telehealth revolution, which raises concerns for health equity during and after the COVID-19 pandemic. Without proactive efforts to address both patient- and provider-related digital barriers associated with socioeconomic status, the wide-scale implementation of telehealth amid COVID-19 may reinforce disparities in health access in already marginalized and underserved communities. To ensure greater telehealth equity, policy changes should address barriers faced overwhelmingly by marginalized patient populations and those who serve them., Context: The COVID-19 pandemic has catalyzed fundamental shifts across the US health care delivery system, including a rapid transition to telehealth. Telehealth has many potential advantages, including maintaining critical access to care while keeping both patients and providers safe from unnecessary exposure to the coronavirus. However, not all health care providers and patients are equally ready to take part in this digital revolution, which raises concerns for health equity during and after the COVID-19 pandemic., Methods: The study analyzed data about small primary care practices' telehealth use and barriers to telehealth use collected from rapid-response surveys administered by the New York City Department of Health and Mental Hygiene's Bureau of Equitable Health Systems and New York University from mid-April through mid-June 2020 as part of the city's efforts to understand how primary care practices were responding to the COVID-19 pandemic following New York State's stay-at-home order on March 22. We focused on small primary care practices because they represent 40% of primary care providers and are disproportionately located in low-income, minority or immigrant areas that were more severely impacted by COVID-19. To examine whether telehealth use and barriers differed based on the socioeconomic characteristics of the communities served by these practices, we used the Centers for Disease Control and Prevention Social Vulnerability Index (SVI) to stratify respondents as being in high-SVI or low-SVI areas. We then characterized respondents' telehealth use and barriers to adoption by using means and proportions with 95% confidence intervals. In addition to a primary analysis using pooled data across the five waves of the survey, we performed sensitivity analyses using data from respondents who only took one survey, first wave only, and the last two waves only., Findings: While all providers rapidly shifted to telehealth, there were differences based on community characteristics in both the primary mode of telehealth used and the types of barriers experienced by providers. Providers in high-SVI areas were almost twice as likely as providers in low-SVI areas to use telephones as their primary telehealth modality (41.7% vs 23.8%; P <.001). The opposite was true for video, which was used as the primary telehealth modality by 18.7% of providers in high-SVI areas and 33.7% of providers in low-SVI areas (P <0.001). Providers in high-SVI areas also faced more patient-related barriers and fewer provider-related barriers than those in low-SVI areas., Conclusions: Between April and June 2020, telehealth became a prominent mode of primary care delivery in New York City. However, the transition to telehealth did not unfold in the same manner across communities. To ensure greater telehealth equity, policy changes should address barriers faced overwhelmingly by marginalized patient populations and those who serve them., (© 2021 Milbank Memorial Fund.)

Background: A stepped-wedge, cluster randomized controlled trial assessed the effectiveness of practice facilitation (PF) for adoption of guidelines for prevention and treatment of cardiovascular disease risk factors. This study estimated the associated cost of PF for guideline adoption in small, private primary care practices., Methods: The cost analysis included categories for start-up costs, intervention costs, and practice staff costs for the implemented PF-guided intervention. We estimated the total 1-year costs to operate the program and calculated the mean and range of the cost-per-practice by quarter of the intervention. We estimated the lower and upper bounds for all salary expenses, rounding to the nearest $100., Results: Total 1-year intervention costs for all 261 practices ranged from $7,900,000 to $10,200,000, with program and practice salaries comprising $6,600,000-$8,400,000 of the total. Start-up costs were a small proportion (3%) of the total 1-year costs. Excluding start-up costs, quarter 1 cost-per-practice was the most expensive at $20,400-$26,700, and quarter 4 was the least expensive at about $10,000. Practice staff time (compared with program staff time) was the majority of the staffing costs at 75-84%., Conclusions: The PF strategy costs approximately $10,000 per practice per quarter for program and practice costs, once implemented and running at highest efficiency. Whether this program is "worth it" to the decision-maker depends on the relative costs and effectiveness of their other options for improving cardiovascular risk reduction., Trial Registration: This study is retrospectively registered on January 5, 2016, at www.clinicaltrials.gov as NCT02646488 .

Background: There is no commonly accepted comprehensive framework for describing the practical specifics of external support for practice change. Our goal was to develop such a taxonomy that could be used by both external groups or researchers and health care leaders., Methods: The leaders of 8 grants from Agency for Research and Quality for the EvidenceNOW study of improving cardiovascular preventive services in over 1500 primary care practices nationwide worked collaboratively over 18 months to develop descriptions of key domains that might comprehensively characterize any external support intervention. Combining literature reviews with our practical experiences in this initiative and past work, we aimed to define these domains and recommend measures for them., Results: The taxonomy includes 1 domain to specify the conceptual model(s) on which an intervention is built and another to specify the types of support strategies used. Another 5 domains provide specifics about the dose/mode of that support, the types of change process and care process changes that are encouraged, and the degree to which the strategies are prescriptive and standardized. A model was created to illustrate how the domains fit together and how they would respond to practice needs and reactions., Conclusions: This taxonomy and its use in more consistently documenting and characterizing external support interventions should facilitate communication and synergies between 3 areas (quality improvement, practice change research, and implementation science) that have historically tended to work independently. The taxonomy was designed to be as useful for practices or health systems managing change as it is for research., Competing Interests: Conflict of interest: None., (© Copyright 2021 by the American Board of Family Medicine.)

Background: Effective strategies are needed to increase implementation and sustainability of evidence-based tobacco dependence treatment (TDT) in public health systems in low- and middle-income countries (LMICs). Our two-arm cluster randomized controlled trial (VQuit) found that a multicomponent implementation strategy was effective in increasing provider adherence to TDT guidelines in commune health center (CHCs) in Vietnam. In this paper, we present findings from a post-implementation qualitative assessment of factors influencing effective implementation and program sustainability., Methods: We conducted semi-structured qualitative interviews (n = 52) with 13 CHC medical directors (i.e., physicians), 25 CHC health care providers (e.g., nurses), and 14 village health workers (VHWs) in 13 study sites. Interviews were transcribed and translated into English. Two qualitative researchers used both deductive (guided by the Consolidated Framework for Implementation Research) and inductive approaches to analysis., Results: Facilitators of effective implementing of TDT included training and point-of-service tools (e.g., desktop chart with prompts for offering brief counseling) that increased knowledge and self-efficacy, patient demand for TDT, and a referral system, available in arm 2, which reduced the provider burden by shifting more intensive cessation counseling to a trained VHW. The primary challenges to sustainability were competing priorities that are driven by the Ministry of Health and may result in fewer resources for TDT compared with other health programs. However, providers and VHWs suggested several options for adapting the intervention and implementation strategies to address challenges and increasing engagement of local government committees and other sectors to sustain gains., Conclusion: Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT. In addition, the results illustrate the dynamic interplay between barriers and facilitators for sustaining TDT at the policy and community/practice level, particularly in the context of centralized public health systems like Vietnam's. Sustaining gains in practice improvement and clinical outcomes will require strategies that include ongoing engagement with policymakers and other stakeholders at the national and local level, and planning for adaptations and subsequent resource allocations in order to meet the World Health Organization's goals promoting access to effective treatment for all tobacco users., Trial Registration: NCT02564653 , registered September 2015.

Introduction: Practice facilitation is a promising practice transformation strategy, but further examination of its effectiveness in improving adoption of guidelines for multiple cardiovascular disease risk factors is needed. The objective of the study is to determine whether practice facilitation is effective in increasing the proportion of patients meeting the Million Hearts ABCS outcomes: (A) aspirin when indicated, (B) blood pressure control, (C) cholesterol management, and (S) smoking screening and cessation intervention., Study Design: The study used a stepped-wedge cluster RCT design with 4 intervention waves. Data were extracted for 13 quarters between January 1, 2015 and March 31, 2018, which encompassed the control, intervention, and follow-up periods for all waves, and analyzed in 2019., Setting/participants: A total of 257 small independent primary care practices in New York City were randomized into 1 of 4 waves., Intervention: The intervention consisted of practice facilitators conducting at least 13 practice visits over 1 year, focused on capacity building and implementing system and workflow changes to meet cardiovascular disease care guidelines., Main Outcome Measures: The main outcomes were the Million Hearts' ABCS measures. Two additional measures were created: (1) proportion of tobacco users who received a cessation intervention (smokers counseled) and (2) a composite measure that assessed the proportion of patients meeting treatment targets for A, B, and C (ABC composite)., Results: The S measure improved when comparing follow-up with the control period (incidence rate ratio=1.152, 95% CI=1.072, 1.238, p<0.001) and when comparing follow-up with intervention (incidence rate ratio=1.060, 95% CI=1.013, 1.109, p=0.007). Smokers counseled improved when comparing the intervention period with control (incidence rate ratio=1.121, 95% CI=1.037, 1.211, p=0.002)., Conclusions: Increasing the impact of practice facilitation programs that target multiple risk factors may require a longer, more intense intervention and greater attention to external policy and practice context., Trial Registration: This study is registered at www.clinicaltrials.gov NCT02646488., (Copyright © 2020 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Aim: To identify barriers to implementing the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) Article 14 guidelines on tobacco dependence treatment (TDT)., Design: Cross-sectional survey conducted from December 2014 to July 2015 to assess implementation of Article 14 recommendations., Setting and Participants: Survey respondents (n = 127 countries) who completed an open-ended question on the 26-item survey., Measurements: The open-ended question asked the following: 'In your opinion, what are the main barriers or challenges to developing further tobacco dependence treatment in your country?'. We conducted thematic analysis of the responses., Findings: The most frequently reported barriers included a lack of health-care system infrastructure (n = 86) (e.g. treatment not integrated into primary care, lack of health-care worker training), low political priority (n = 66) and lack of funding (n = 51). The absence of strategic plans and national guidelines for Article 14 implementation emerged as subthemes of political priority. Also described as barriers were negative provider attitudes towards offering offer TDT (n = 11), policymakers' lack of awareness about the effectiveness and affordability of TDT (n = 5), public norms supporting tobacco use (n = 11), a lack of health-care leadership and expertise in the area of TDT (n = 6) and a lack of grassroots and multi-sector networks supporting policy implementation (n = 8). The analysis captured patterns of co-occurring themes that linked, for example, low levels of political support with a lack of funding necessary to develop health-care infrastructure and capacity to implement Article 14., Conclusion: Important barriers to implementing the Framework Convention on Tobacco Control Article 14 guidelines include lack of a health-care system infrastructure, low political priority and lack of funding., (© 2019 Society for the Study of Addiction.)

Objective: HealthyHearts NYC was a stepped wedge randomized control trial that tested the effectiveness of practice facilitation on the adoption of cardiovascular disease guidelines in small primary care practices. The objective of this study was to identify was to identify attributes of small practices that signaled they would perform well in a practice facilitation intervention implementation., Methods: A mixed methods multiple-case study design was used. Six small practices were selected representing 3 variations in meeting the practice-level benchmark of >70% of hypertensive patients having controlled blood pressure. Inductive and deductive approaches were used to identify themes and assign case ratings. Cross-case rating comparison was used to identify attributes of high performing practices., Results: Our first key finding is that the high-performing and improved practices in our study looked and acted similarly during the intervention implementation. The second key finding is that 3 attributes emerged in our analysis of determinants of high performance in small practices: (1) advanced use of the EHR; (2) dedicated resources and commitment to quality improvement; and (3) actively engaged lead clinician and office manager., Conclusions: These attributes may be important determinants of high performance, indicating not only a small practice's capability to engage in an intervention but possibly also its readiness to change. We recommend developing tools to assess readiness to change, specifically for small primary care practices, which may help external agents, like practice facilitators, better translate intervention implementations to context.

Purpose: Small independent primary care practices (SIPs) often lack the resources to implement system changes. HealthyHearts NYC, funded through the EvidenceNOW initiative of the Agency for Healthcare Research and Quality, studied the effectiveness of practice facilitation to improve cardiovascular disease- related care in 257 SIPs. We sought to understand SIP clinicians' perspectives on the benefits of practice facilitation., Methods: We conducted in-depth interviews with 19 SIP clinicians enrolled in HealthyHearts NYC. Interviews were transcribed and coded using deductive and inductive approaches. To understand whether the perceived benefits of practice facilitation differ based on the availability of internal staff for quality improvement (QI), we compared themes pertaining to benefits between practices with 3 or fewer office staff vs more than 3 office staff., Results: Clinicians perceived 2 main benefits of practice facilitation. First, facilitators served as a connection to the external health care environment for SIPs, often through teaching and information sharing. Second, facilitators provided electronic health record (EHR)/data expertise, often by teaching functionality and completing technical assistance and tasks. SIPs with more than 3 office staff felt that facilitators provided benefits primarily through teaching, whereas SIPs with 3 or fewer staff felt that facilitators also provided hands-on support. At the intersections of these benefits, there emerged 3 central practice facilitation benefits: (1) creating awareness of quality gaps, (2) connecting practices to information, resources, and strategies, and (3) optimizing the EHR for QI goals., Conclusions: SIP clinicians perceived practice facilitation to be an important resource for connecting their practice to the external health care environment and resources, and helping their practice build QI capacity through teaching, hands-on support, and EHR-driven solutions., (© 2019 Annals of Family Medicine, Inc.)

Introduction: Our team conducted a cluster randomized controlled trial (DUET) that compared the effectiveness of three theory-driven, implementation strategies on dental provider adherence to tobacco dependence treatment guidelines (TDT). In this paper we describe the process of adapting the implementation strategies to the local context of participating dental public health clinics in New York City., Methods: Eighteen dental clinics were randomized to one of three study arms testing several implementation strategies: Current Best Practices (CBP) (i.e. staff training, clinical reminder system and Quitline referral system); CBP + Performance Feedback (PF) (i.e. feedback reports on provider delivery of TDT); and CBP + PF + Pay-for-Performance (i.e. financial incentives for provision of TDT). Through an iterative process, we used Stirman's modification framework to classify, code and analyze modifications made to the implementation strategies., Results: We identified examples of six of Stirman's twelve content modification categories and two of the four context modification categories. Content modifications were classified as: tailoring, tweaking or refining (49.8%), adding elements (14.1%), departing from the intervention (9.3%), loosening structure (4.4%), lengthening and extending (4.4%) and substituting elements (4.4%). Context modifications were classified as those related to personnel (7.9%) and to the format/channel (8.8%) of the intervention delivery. Common factors associated with adaptations that arose during the intervention included staff changes, time constraints, changes in leadership preferences and functional limitations of to the Electronic Dental Record., Conclusions: This study offers guidance on how to capture intervention adaptation in the context of a multi-level intervention aimed at implementing sustainable changes to optimize TDT in varying public health dental settings.

Introduction: Hospitalization is a unique opportunity for smoking cessation, but prior interventions have measured efficacy with narrowly defined populations. The objective of this study was to enroll smokers admitted to two "safety net" hospitals and compare the effectiveness of two post-discharge cessation interventions., Design: A randomized comparative effectiveness trial was conducted., Setting/participants: At two New York City public hospitals, every hospitalized patient identified as a smoker (based on admission records) was approached. Inclusion criteria were: smoked cigarettes in the past 30 days; spoke English, Spanish, or Mandarin; had a U.S. phone number; not discharged to an institution where follow-up or smoking was limited; and not pregnant/breastfeeding. Of 18,797 patients identified as current smokers between July 2011 and April 2014, a total of 3,047 (16%) were discharged before being approached, 3,273 (17%) were not current smokers, 4,026 (21%) had no U.S. phone number, 2,831 (15%) were ineligible for other reasons, and 3,983 (21%) refused participation. In total, 1,618 (9%) participants enrolled in the study. During follow-up, 69% of participants were reached at 2 months and 68% at 6 months., Intervention: At discharge, participants were randomized to multisession telephone counseling from study staff (n=804) or referral to the state quitline for proactive outreach and counseling (n=814)., Main Outcome Measures: Self-reported abstinence at 6 months was measured. Analyses were conducted in late 2015., Results: One quarter of participants were homeless or in unstable housing, 60% had a history of substance abuse, 43% reported current hazardous drinking, and half had a psychiatric diagnosis other than substance abuse. At follow-up, the rate of abstinence (30-day point prevalence) was higher in the intensive counseling arm than the quitline arm at 2 months (29.0% vs 20.7%; relative risk=1.40; 95% CI=1.13, 1.73) and 6 months (37.4% vs 31.5%; relative risk=1.19; 95% CI=1.01, 1.40)., Conclusions: Intensive counseling was more effective than referral to the state quitline. Long-term abstinence was excellent in both groups. Many patients were not eligible for enrollment despite minimal exclusion criteria., Trial Registration: This study is registered at www.clinicaltrials.gov NCT01363245., Competing Interests: None of the authors have any conflicts of interest to report., (Published by Elsevier Inc.)

Background: HealthyHearts NYC (HHNYC) will evaluate the effectiveness of practice facilitation as a quality improvement strategy for implementing the Million Hearts' ABCS treatment guidelines for reducing cardiovascular disease (CVD) among high-risk patients who receive care in primary care practices in New York City. ABCS refers to (A) aspirin in high-risk individuals; (B) blood pressure control; (C) cholesterol management; and (S) smoking cessation. The long-term goal is to create a robust infrastructure for implementing and disseminating evidence-based practice guidelines (EBPG) in primary care practices., Methods/design: We are using a stepped-wedge cluster randomized controlled trial design to evaluate the implementation process and the impact of practice facilitation (PF) versus usual care on ABCS outcomes in 250 small primary care practices. Randomization is at the practice site level, all of which begin as part of the control condition. The intervention consists of one year of PF that includes a combination of one-on-one onsite visits and shared learning across practice sites. PFs will focus on helping sites implement evidence-based components of patient-centered medical home (PCMH) and the chronic care model (CCM), which include decision support, provider feedback, self-management tools and resources, and linkages to community-based services., Discussion: We hypothesize that practice facilitation will result in superior clinical outcomes compared to usual care; that the effects of practice facilitation will be mediated by greater adoption of system changes in accord with PCMH and CCM; and that there will be increased adaptive reserve and change capacity., Trial Registration: NCT02646488.

Introduction: Lung cancer screening represents an opportunity to deliver smoking cessation advice and assistance to current smokers. However, the current tobacco treatment practices of lung cancer screening sites are unknown. The purpose of this study was to describe organizational priority, current practice patterns, and barriers for delivery of evidence-based tobacco use treatment across lung cancer screening sites within the United States., Methods: Guided by prior work examining readiness of health care providers to deliver tobacco use treatment, we administered a brief online survey to a purposive national sample of site coordinators from 93 lung cancer screening sites., Results: Organizational priority for promoting smoking cessation among lung cancer screening enrollees was high. Most sites reported that, at the initial visit, patients are routinely asked about their current smoking status (98.9%) and current smokers are advised to quit (91.4%). Fewer (57%) sites provide cessation counseling or refer smokers to a quitline (60.2%) and even fewer (36.6%) routinely recommend cessation medications. During follow-up screening visits, respondents reported less attention to smoking cessation advice and treatment. Lack of patient motivation and resistance to cessation advice and treatment, lack of staff training, and lack of reimbursement were the most frequently cited barriers for delivering smoking cessation treatment., Conclusions: Although encouraging that lung cancer screening sites endorsed the importance of smoking cessation interventions, greater attention to identifying and addressing barriers for tobacco treatment delivery is needed in order to maximize the potential benefit of integrating smoking cessation into lung cancer screening protocols., Implications: This study is the first to describe practice patterns, organizational priority, and barriers for delivery of smoking cessation treatment in a national sample of lung cancer screening sites., (© The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: The purpose of this study was to explore the relationship between social norms and attitudes towards ENDS and hookah and use of these products., Methods: We conducted surveys with hookah and ENDS users who regularly used the Internet and social media and analyzed the primary social media account (e.g. Facebook) of each participant, coding all references to nicotine or tobacco products. The survey included domains on perceived favorability, perceived vulnerability and subjective norms., Results: We surveyed 21 ENDS users and 20 hookah users. Both groups used the Internet to look up information about their respective tobacco product (95% for hookah vs. 90% for ENDS). Seventy percent of hookah users had references to hookah on their social media profiles while 43% of ENDS users had references to ENDS on their page. The majority of both groups were exposed to content posted by friends in their social media network about their respective products online. Those who posted on social media about hookah and those who read about ENDS online had lower perceived vulnerability to the health risks associated with tobacco products., Conclusions: Hookah and ENDS users actively use the Internet and social media to obtain and share information about nicotine/tobacco products. Study participants who use hookah were more likely to share photos and discuss hookah related activities via social media than those who use ENDS. Social networks also represent valuable and untapped potential resources for communicating with this group about risks and harm reduction related to emerging nicotine/tobacco products.

Introduction: Dental visits represent an opportunity to identify and help patients quit smoking, yet dental settings remain an untapped venue for treatment of tobacco dependence. The purpose of this analysis was to assess factors that may influence patterns of tobacco-use-related practice among a national sample of dental providers., Methods: We surveyed a representative sample of general dentists practicing in the United States (N = 1,802). Multivariable analysis was used to assess correlates of adherence to tobacco use treatment guidelines and to analyze factors that influence providers' willingness to offer tobacco cessation assistance if reimbursed for this service., Results: More than 90% of dental providers reported that they routinely ask patients about tobacco use, 76% counsel patients, and 45% routinely offer cessation assistance, defined as referring patients for cessation counseling, providing a cessation prescription, or both. Results from multivariable analysis indicated that cessation assistance was associated with having a practice with 1 or more hygienists, having a chart system that includes a tobacco use question, having received training on treating tobacco dependence, and having positive attitudes toward treating tobacco use. Providers who did not offer assistance but who reported that they would change their practice patterns if sufficiently reimbursed were more likely to be in a group practice, treat patients insured through Medicaid, and have positive attitudes toward treating tobacco dependence., Conclusion: Findings indicate the potential benefit of increasing training opportunities and promoting system changes to increase involvement of dental providers in conducting tobacco use treatment. Reimbursement models should be tested to assess the effect on dental provider practice patterns.

Background: Organizational culture is an important but underinvestigated feature of the work environment that can impact provider behavior, including adherence to clinical practice guidelines. There is substantial evidence that physician assistance to smokers can produce significant reductions in tobacco use. However, this evidence has not been well translated into practice, as only a small proportion of smokers receive recommended treatment during medical visits., Purpose: This study examines organizational culture as a contextual feature of primary care clinics and its impact on adherence to evidence-based guidelines for treating tobacco use., Methodology: Cross-sectional survey data were collected from 500 primary care providers in 60 community clinics located in New York City. Relationships between provider adherence to "5A" clinical guidelines, as recommended by the U.S. Public Health Service, and both provider and organizational covariates were described. We used hierarchical linear modeling to examine the associations between clinic culture and provider treatment patterns., Findings: Providers in clinics with stronger "group/clan," "hierarchical," and "rational" culture types, as compared with a "developmental" culture, reported greater adherence to 5A guidelines (p < .05). System-level structures and care processes were positively associated (p < .01), whereas number of ongoing quality initiatives was negatively associated with 5A delivery (p < .05). Provider familiarity with guidelines (p < .01), confidence with cessation counseling (p < .05), and perceived effectiveness in helping smokers quit were associated with more frequent 5A intervention (p < .01)., Practice Implications: Findings suggest that organizational culture can influence provider adherence to cessation treatment guidelines, even when controlling for other factors known to affect practice patterns. Specifically, cultures that emphasize human resources and performance standards are conducive to integrating 5A guidelines into routine practice. Understanding the role of organizational culture enables healthcare managers and practitioners to be strategic when implementing, and also sustaining, use of evidence-based guidelines.

Background: Although dental care settings provide an exceptional opportunity to reach smokers and provide brief cessation advice and treatment to reduce oral and other tobacco-related health conditions, dental care providers demonstrate limited adherence to evidence-based guidelines for treatment of tobacco use and dependence., Methods/design: Guided by a multi-level, conceptual framework that emphasizes changes in provider beliefs and organizational characteristics as drivers of improvement in tobacco treatment delivery, the current protocol will use a cluster, randomized design and multiple data sources (patient exit interviews, provider surveys, site observations, chart audits, and semi-structured provider interviews) to study the process of implementing clinical practice guidelines for treating tobacco dependence in 18 public dental care clinics in New York City. The specific aims of this comparative-effectiveness research trial are to: compare the effectiveness of three promising strategies for implementation of tobacco use treatment guidelines-staff training and current best practices (CBP), CBP + provider performance feedback (PF), and CBP + PF + provider reimbursement for delivery of tobacco cessation treatment (pay-for-performance, or P4P); examine potential theory-driven mechanisms hypothesized to explain the comparative effectiveness of three strategies for implementation; and identify baseline organizational factors that influence the implementation of evidence-based tobacco use treatment practices in dental clinics. The primary outcome is change in providers' tobacco treatment practices and the secondary outcomes are cost per quit, use of tobacco cessation treatments, quit attempts, and smoking abstinence., Discussion: We hypothesize that the value of these promising implementation strategies is additive and that incorporating all three strategies (CBP, PF, and P4P) will be superior to CBP alone and CBP + PF in improving delivery of cessation assistance to smokers. The findings will improve knowledge pertinent to the implementation, dissemination, and sustained utilization of evidence-based tobacco use treatment in dental practices., Trial Registration: NCT01615237.

This study tested the feasibility of using information technology to improve dentists' adherence to the Treating Tobacco Use and Dependence Clinical Practice Guidelines by offering a web-based computer-mediated clinical decision support system (CDSS) for tobacco use treatment in dental clinics. The authors developed a CDSS tool, deployed the software in one of New York University College of Dentistry's general practice clinics, interviewed associate student dentists, and reviewed a random selection of patients' charts to determine if, after implementation, there were changes in tobacco use screening and referral to treatment. Students reported that the CDSS was easy to use, increased their efficiency, and provided better quality of evidence than was available prior to the intervention. Chart reviews demonstrated that, after CDSS implementation, patients in the target clinic were significantly more likely to be screened for tobacco use (<0.001), and tobacco-using patients were more likely to be advised (<0.001), referred to the state's Quit Line (<0.001), and prescribed nicotine replacement therapy (0.035). This study concludes that it is feasible to implement a CDSS for tobacco use treatment in dental clinics. The CDSS is a promising method for improving adherence to tobacco use treatment guidelines and warrants further study.

Objective: To examine the chronic care model (CCM) as a framework for improving provider delivery of 5A tobacco cessation services., Methods: Cross-sectional surveys were used to obtain data from 497 health care providers in 60 primary care clinics serving low-income patients in New York City. A hierarchical generalized linear modeling approach to ordinal regression was used to estimate the probability of full 5A service delivery, adjusting for provider covariates and clustering effects. We examined associations between provider delivery of 5A services, clinic implementation of CCM elements tailored for treating tobacco use, and the degree of CCM integration in clinics., Principal Findings: Providers practicing in clinics with enhanced delivery system design, clinical information systems, and self-management support for cessation were 2.04-5.62 times more likely to perform all 5A services ( p<.05). CCM integration in clinics was also positively associated with 5As delivery. Compared with none, implementation of one to six CCM elements corresponded with a 3.69-30.9 increased odds of providers delivering the full spectrum of 5As ( p<.01)., Conclusions: Findings suggest that the CCM facilitates provider adherence to the Public Health Service 5A clinical guideline. Achieving the full benefits of systems change may require synergistic adoption of all model components.

Women with PCO have a unique but poorly characterized disorder of insulin action. Obese (n = 16) and nonobese (n = 14) PCO women and age- and weight-matched normal, nondiabetic ovulatory women (obese, n = 15; nonobese, n = 17) had insulin action determined in vivo with sequential multiple insulin dose euglycemic clamps and in isolated abdominal adipocytes to clarify the mechanisms of insulin resistance. PCO resulted in significant increases in the ED50 insulin for glucose utilization in vivo (P less than 0.001) and in adipocytes (P less than 0.01), without significant changes in adipocyte insulin-binding sites. PCO also resulted in significant decreases in maximal insulin-stimulated rates of glucose utilization in vivo (P less than 0.01) and in adipocytes (P less than 0.01). Obesity resulted in smaller decreases in insulin sensitivity than PCO (ED50 insulin, P less than 0.001 in vivo and P less than 0.05 in adipocytes), but greater decreases in insulin responsiveness (Vmax, P less than 0.001 in vivo and in adipocytes). The ED50 insulin for suppression of HGP was increased only in obese PCO women (P less than 0.001), and the interactions between PCO and obesity on this parameter were statistically significant. No significant correlations between androgen or estrogen levels and adipocyte insulin binding or action were found. Because insulin binding was not changed, we conclude that the major lesion causing insulin resistance in PCO is a striking decrease in insulin sensitivity secondary to a defect in the insulin receptor and/or postreceptor signal transduction. PCO also is associated with modest but significant decreases in glucose transport. These defects in insulin action appear to represent intrinsic abnormalities that are independent of obesity, metabolic derangements, body fat topography, and sex hormone levels. Conversely, changes in hepatic insulin sensitivity appear to be acquired with obesity.

Polycystic ovary syndrome is a disorder of unknown cause characterized by anovulation, hyperandrogenism, and gonadotropin secretory abnormalities producing oligo-ovulation or anovulation. Hyperinsulinemia and insulin resistance are important features of this syndrome. Because other causes of androgen excess may produce similar clinical and biochemical findings, PCO remains a diagnosis of exclusion. Treatment is directed toward relieving symptoms of hyperandrogenemia in order to stimulate ovulation, correcting obesity, and inducing regular menses to reduce the risk of endometrial cancer.