Bundling Colorectal Cancer Screening Outreach with Screening for Social Risk in Federally Qualified Health Centers: A Stepped-Wedge Implementation-Effectiveness Study.

BACKGROUND: Bundling is combining individual interventions to meet quality metrics. Bundling offers of cancer screening with screening for social determinants of health (SDOH) may enable health centers to assist patients with social risks and yield efficiencies. OBJECTIVE: To measure effects of bundling fecal immunochemical testing (FIT) and SDOH screening in federally qualified health centers (FQHCs). DESIGN: Clustered stepped-wedge trial. PARTICIPANTS: Four Massachusetts FQHCs randomized to implement bundled FIT-SDOH over 8-week "steps." INTERVENTION: Outreach to 50-75-year-olds overdue for CRC screening to offer FIT with SDOH screening. The implementation strategy used facilitation and training for data monitoring and reporting. MAIN MEASURES: Implementation process descriptions, data from facilitation meetings, and CRC and SDOH screening rates. Rates were compared between implementation and control FQHCs in each "step" by fitting generalized linear mixed-effects models with random intercepts for FQHCs, patients, and "step" by FQHC. KEY RESULTS: FQHCs tailored implementation processes to their infrastructure, workflows, and staffing and prioritized different groups for outreach. Two FQHCs used population health outreach, and two integrated FIT-SDOH within established programs, such as pre-visit planning. Of 34,588 patients overdue for CRC screening, 54% were female; 20% Black, 11% Latino, 10% Asian, and 47% white; 32% had Medicaid, 16% Medicare, 32% private insurance, and 11% uninsured. Odds of CRC screening completion in implementation "steps" compared to controls were higher overall and among groups prioritized for outreach (overall: adjusted odds ratio (aOR) 2.41, p = 0.005; prioritized: aOR 2.88, p = 0.002). Odds of SDOH screening did not differ across "steps." CONCLUSIONS: As healthcare systems are required to conduct more screenings, it is notable that outreach for a long-standing cancer screening requirement increased screening, even when bundled with a newer screening requirement. This outreach was feasible in a real-world safety-net clinical population and may conserve resources, especially compared to more complex or intensive outreach strategies. CLINICAL TRIALS REGISTRATION: NCT04585919.

Creating research-ready partnerships: the initial development of seven implementation laboratories to advance cancer control.

BACKGROUND: In 2019-2020, with National Cancer Institute funding, seven implementation laboratory (I-Lab) partnerships between scientists and stakeholders in 'real-world' settings working to implement evidence-based interventions were developed within the Implementation Science Centers in Cancer Control (ISC3) consortium. This paper describes and compares approaches to the initial development of seven I-Labs in order to gain an understanding of the development of research partnerships representing various implementation science designs. METHODS: In April-June 2021, members of the ISC3 Implementation Laboratories workgroup interviewed research teams involved in I-Lab development in each center. This cross-sectional study used semi-structured interviews and case-study-based methods to collect and analyze data about I-Lab designs and activities. Interview notes were analyzed to identify a set of comparable domains across sites. These domains served as the framework for seven case descriptions summarizing design decisions and partnership elements across sites. RESULTS: Domains identified from interviews as comparable across sites included engagement of community and clinical I-Lab members in research activities, data sources, engagement methods, dissemination strategies, and health equity. The I-Labs use a variety of research partnership designs to support engagement including participatory research, community-engaged research, and learning health systems of embedded research. Regarding data, I-Labs in which members use common electronic health records (EHRs) leverage these both as a data source and a digital implementation strategy. I-Labs without a shared EHR among partners also leverage other sources for research or surveillance, most commonly qualitative data, surveys, and public health data systems. All seven I-Labs use advisory boards or partnership meetings to engage with members; six use stakeholder interviews and regular communications. Most (70%) tools or methods used to engage I-Lab members such as advisory groups, coalitions, or regular communications, were pre-existing. Think tanks, which two I-Labs developed, represented novel engagement approaches. To disseminate research results, all centers developed web-based products, and most (n = 6) use publications, learning collaboratives, and community forums. Important variations emerged in approaches to health equity, ranging from partnering with members serving historically marginalized populations to the development of novel methods. CONCLUSIONS: The development of the ISC3 implementation laboratories, which represented a variety of research partnership designs, offers the opportunity to advance understanding of how researchers developed and built partnerships to effectively engage stakeholders throughout the cancer control research lifecycle. In future years, we will be able to share lessons learned for the development and sustainment of implementation laboratories.

Tobacco Use and Treatment of Tobacco Dependence Among People With Human Immunodeficiency Virus: A Practical Guide for Clinicians.

More than 40% of people with human immunodeficiency virus (PWH) in the United States smoke tobacco cigarettes. Among those on antiretroviral therapy, smoking decreases life expectancy more than human immunodeficiency virus (HIV) itself. Most PWH who smoke want to quit, but tobacco dependence treatment has not been widely integrated into HIV care. This article summarizes the epidemiology of tobacco use among PWH, health consequences of tobacco use and benefits of cessation in PWH, and studies of treatment for tobacco dependence among the general population and among PWH. We provide practical guidance for providers to treat tobacco dependence among PWH. A 3-step Ask-Advise-Connect framework includes asking about tobacco use routinely during clinical encounters, advising about tobacco cessation with emphasis on the benefits of cessation, and actively connecting patients to cessation treatments, including prescription of pharmacotherapy (preferably varenicline) and direct connection to behavioral interventions via telephone quitline or other means to increase the likelihood of a successful quit attempt.

Longitudinal Electronic Cigarette Use Among Patients Recently Diagnosed With Cancer Enrolled in a Smoking Cessation Trial.

INTRODUCTION: Many cancer patients who smoke report concurrent e-cigarette use. Using a mixed-methods approach, we aimed to (1) describe longitudinal e-cigarette use over 6 months after a cancer diagnosis and (2) assess the association between e-cigarette use and smoking cessation, among cancer patients in a smoking cessation trial. AIMS AND METHODS: Data were from a 2-site randomized controlled trial of Standard (brief counseling) versus Intensive treatment (sustained counseling plus smoking cessation medication) in individuals who smoke recently diagnosed with cancer. Participants (n = 303) reported e-cigarette use at baseline, 3 months, and 6 months. Biochemically-verified past 7-day cigarette abstinence was collected at 6 months. Qualitative interviews at 6 months explored factors related to e-cigarette use. RESULTS: E-cigarette use prevalence was highest between baseline and 3 months (16%) and declined over time. Participants using e-cigarettes at follow-up had higher baseline cigarette dependence and smoked more heavily. Multivariable analyses found no significant association between follow-up e-cigarette use and 6-month cigarette abstinence. E-cigarette use at follow-up was higher in the Standard versus Intensive treatment group (p = .003 and .001 at 3 and 6 mo, respectively). Smoking cessation and health concerns were primary reasons for using e-cigarettes. CONCLUSIONS: Among individuals who smoke recently diagnosed with cancer and enrolled in a smoking cessation intervention trial, e-cigarette use during trial participation was not associated with smoking abstinence. Individuals who chose to use e-cigarettes were less likely to be receiving intensive cessation support as part of the trial. Further studies are needed to evaluate the association between e-cigarette use and smoking cessation in cancer patients. IMPLICATIONS: E-cigarette use was not associated with cigarette abstinence at 6 months among adults who smoke recently diagnosed with cancer enrolled in a smoking cessation trial. Individuals with easier access to evidence-based smoking cessation treatment may be less likely to use e-cigarettes.

Treatment of Tobacco Smoking: A Review.

IMPORTANCE: More deaths in the US are attributed to cigarette smoking each year than to any other preventable cause. Approximately 34 million people and an estimated 14% of adults in the US smoke cigarettes. If they stopped smoking, they could reduce their risk of tobacco-related morbidity and mortality and potentially gain up to 10 years of life. OBSERVATIONS: Tobacco smoking is a chronic disorder maintained by physical nicotine dependence and learned behaviors. Approximately 70% of people who smoke cigarettes want to quit smoking. However, individuals who attempt to quit smoking make an average of approximately 6 quit attempts before achieving long-term abstinence. Both behavioral counseling and pharmacotherapy while using nicotine replacement therapy (NRT) products, varenicline, or bupropion are effective treatments when used individually, but they are most effective when combined. In a meta-analysis including 19 488 people who smoked cigarettes, the combination of medication and behavioral counseling was associated with a quit rate of 15.2% over 6 months compared with a quit rate of 8.6% with brief advice or usual care. The EAGLES trial, a randomized double-blind clinical trial of 8144 people who smoked, directly compared the efficacy and safety of varenicline, bupropion, nicotine patch, and placebo and found a significantly higher 6-month quit rate for varenicline (21.8%) than for bupropion (16.2%) and the nicotine patch (15.7%). Each therapy was more effective than placebo (9.4%). Combining a nicotine patch with other NRT products is more effective than use of a single NRT product. Combining drugs with different mechanisms of action, such as varenicline and NRT, has increased quit rates in some studies compared with use of a single product. Brief or intensive behavioral support can be delivered effectively in person or by telephone, text messages, or the internet. The combination of a clinician's brief advice to quit and assistance to obtain tobacco cessation treatment is effective when routinely administered to tobacco users in virtually all health care settings. CONCLUSIONS AND RELEVANCE: Approximately 34 million people in the US smoke cigarettes and could potentially gain up to a decade of life expectancy by stopping smoking. First-line therapy should include both pharmacotherapy and behavioral support, with varenicline or combination NRT as preferred initial interventions.

Tobacco Use and Subsequent Cessation Among Hospitalized Patients in Mumbai, India: A Longitudinal Study.

INTRODUCTION: Hospitalization is an important setting to address tobacco use. Little is known about post-discharge cessation and treatment use in low- and middle-income countries. Our objective was to assess tobacco use after hospital discharge among patients in Mumbai, India. METHODS: Longitudinal observational study of inpatients (≥15 years) admitted at one hospital from November 2015 to October 2016. Patients reporting current tobacco use were surveyed by telephone after discharge. RESULTS: Of 2894 inpatients approached, 2776 participated and 15.7% (N = 437) reported current tobacco use, including 5.3% (N = 147) smokers, 9.1% (N = 252) smokeless tobacco (SLT) users, and 1.4% (N = 38) dual users. Excluding dual users, SLT users, compared to smokers, were less likely to report a plan to quit after discharge (42.6% vs. 54.2%, p = .04), a past-year quit attempt (38.1% vs. 52.7%, p = .004), to agree that tobacco has harmed them (57.9% vs. 70.3%, p = .02) or caused their hospitalization (43.4% vs. 61.4%, p < .001). After discharge, 77.6% of smokers and 78.6% of SLT users reported trying to quit (p = .81). Six-month continuous abstinence after discharge was reported by 27.2% of smokers and 24.6% of SLT users (p = .56). Nearly all relapses to tobacco use after discharge occurred within 30 days and did not differ by tobacco type (log-rank p = .08). Use of evidence-based cessation treatment was reported by 6.5% (N = 26). CONCLUSIONS: Three-quarters of tobacco users in a Mumbai hospital attempted to quit after discharge. One-quarter reported continuous tobacco abstinence for 6 months despite little use of cessation treatment. Increasing post-discharge cessation support could further increase cessation rates and improve patient outcomes. IMPLICATIONS: No prior study has measured the patterns of tobacco use and cessation among hospitalized tobacco users in India. Three-quarters of tobacco users admitted to a hospital in Mumbai attempted to quit after discharge, and one-quarter remained tobacco-free for 6 months, indicating that hospitalization may be an opportune time to offer a cessation intervention. Although smokers and SLT users differed in socioeconomic status, perceived risks and interest in quitting, they did not differ in their ability to stay abstinent after hospital discharge.

Proactively Offered Text Messages and Mailed Nicotine Replacement Therapy for Smokers in Primary Care Practices: A Pilot Randomized Trial.

INTRODUCTION: Proactive, population health cessation programs can guide efforts to reach smokers outside of the clinic to encourage quit attempts and treatment use. AIMS AND METHODS: This study aimed to measure trial feasibility and preliminary effects of a proactive intervention offering text messages (TM) and/or mailed nicotine replacement therapy (NRT) to smokers in primary care clinics. From 2017 to 2019 we performed a pilot randomized trial comparing brief telephone advice (control: BA), TM, 2 weeks of mailed NRT, or both interventions (TM + NRT). Patients were identified using electronic health records and contacted proactively by telephone to assess interest in the study. We compared quit attempts, treatment use, and cessation in the intervention arms with BA. RESULTS: Of 986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment. On average, patients in the TM arms received 159 messages (99.4% sent, 0.6% failed), sent 19 messages, and stayed in the program for 61 days. In all groups, a majority of patients reported quit attempts (BA 67% vs. TM 86% [p = .07], NRT 81% [p = .18], TM + NRT 79% [p = .21]) and NRT use (BA 51% vs. NRT 83% [p = .007], TM 65% [p = .25], TM + NRT 76% [p = .03]). Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p = .09), NRT 28% (p = .06), and TM + NRT 23% (p = .14). CONCLUSIONS: Proactively offering TM or mailed nicotine medications was feasible among primary care smokers and a promising approach to promote quit attempts and short-term abstinence. IMPLICATIONS: Proactive intervention programs to promote quit attempts outside of office visits among smokers enrolled in primary care practices are needed. TM have potential to engage smokers not planning to quit or to support smokers to make a planned quit attempt. This pilot study demonstrates the feasibility of testing a proactive treatment model including TM and/or mailed NRT to promote quit attempts, treatment use, and cessation among nontreatment-seeking smokers in primary care. CLINICALTRIALS.GOV IDENTIFIER: NCT03174158.

Tobacco Dependence Treatment Training Programs: An International Survey.

INTRODUCTION: In line with Article 14 guidelines for the WHO Framework Convention on Tobacco Control, we aimed to assess the progress in training individuals to deliver tobacco cessation treatment. METHODS: Cross-sectional web-based survey in May-September 2013 among 122 experts in tobacco control and training from 84 countries (73% response rate among 115 countries surveyed). We measured training program prevalence, participants, and challenges faced. RESULTS: Overall, 21% (n = 18/84) of countries, mostly low and middle-income countries (LMICs; P = .002), reported no training program. Among 66 countries reporting at least one training program, most (84%) trained healthcare professionals but 54% also trained other individuals including community health workers, teachers, and religious leaders. Most programs (54%) cited funding challenges, although stability of funding varied by income level. Government funding was more commonly reported in higher income countries (high 56%, upper middle 50%, lower middle 27%, low 25%; P = .03) while programs in LMICs relied more on nongovernmental organizations (high 11%, upper middle 37%, lower middle 27%, low 38%; P = .02). CONCLUSIONS: One in five countries reported having no tobacco treatment training program representing little progress in terms of training individuals to deliver tobacco treatment in LMICs. Without more trained tobacco treatment providers, one of the tenets of Article 14 is not yet being met and health inequalities are likely to widen. More effort and resources are needed to ensure that healthcare worker educational programs include training to assess tobacco use and deliver brief advice and that training is available for individuals outside the healthcare system in areas with limited healthcare access.

Overuse of colonoscopy for colorectal cancer screening and surveillance.

BACKGROUND: Ongoing efforts to increase colorectal cancer (CRC) screening rates have raised concerns that these exams may be overused, thereby subjecting patients to unnecessary risks and wasting healthcare resources. OBJECTIVE: Our aim was to measure overuse of screening and surveillance colonoscopies among average-risk adults, and to identify correlates of overuse. DESIGN, SETTING, AND PARTICIPANTS: Our approach was a retrospective cohort study using electronic health record data for patients 50-65 years old with no personal history of CRC or colorectal adenomas with an incident CRC screening colonoscopy from 2001 to 2010 within a multispecialty physician group practice. MAIN OUTCOME MEASURES: We measured time to next screening or surveillance colonoscopy and predictors of overuse (exam performed more than one year earlier than guideline recommended intervals) of colonoscopies. KEY RESULTS: We identified 1,429 adults who had an incident colonoscopy between 2001 and 2010, and they underwent an additional 871 screening or surveillance colonoscopies during a median follow-up of 6 years. Most follow-up screening colonoscopies (88%) and many surveillance colonoscopies (49%) repeated during the study represented overuse. Time to next colonoscopy after incident screening varied by exam findings (no polyp: median 6.9 years, interquartile range [IQR]: 5.1-10.0; hyperplastic polyp: 5.7 years, IQR: 4.9-9.7; low-risk adenoma: 5.1 years, IQR: 3.3-6.3; high-risk adenoma: 2.9 years, IQR: 2.0-3.4, p < 0.001). In logistic regression models of colonoscopy overuse, an endoscopist recommendation for early follow-up was strongly associated with overuse of screening colonoscopy (OR 6.27, 95% CI: 3.15-12.50) and surveillance colonoscopy (OR 13.47, 95% CI 6.61-27.46). In a multilevel logistic regression model, variation in the overuse of screening colonoscopy was significantly associated with the endoscopist performing the previous exam. CONCLUSIONS: Overuse of screening and surveillance exams are common and should be monitored by healthcare systems. Variations in endoscopist recommendations represent targets for interventions to reduce overuse.

Tobacco use among adults initiating treatment for HIV infection in rural Uganda.

We conducted a longitudinal study of tobacco use among adults initiating antiretroviral therapy (ART) in Mbarara, Uganda where 11 % of men and 3 % of women use tobacco according to the 2011 Demographic and Health Survey. In a prospective cohort, self-reported tobacco use was assessed before starting ART and reassessed every 3-4 months. Plasma cotinine, a nicotine metabolite, was measured in a subset of adults pre-ART to verify self-report. Among 496 subjects, 50 (10 %) reported current tobacco use (20 % of men, 6 % of women). Most (53 %) adults with elevated cotinine levels (>15 ng/mL) reported no tobacco use. By 6 months after ART initiation, 33 % of tobacco users had quit (95 % CI 20-46 %). By 5 years, 64 % quit (95 % CI 47-77 %). Self-reported tobacco use among rural Ugandans starting ART was twice as common as among the local background population and use may be underreported. ART initiation could be an opportunity for tobacco cessation interventions.

Do no harm: the impact of implementing cancer prevention strategies on other preventive health measures.

BACKGROUND: Translational efforts to increase uptake of evidence-based practices typically look at those outcomes in isolation of their impact on other aspects of care delivery. If we are in fact to "do no harm", we must consider the possible negative impact of improving use of one practice on other quality measures. Alternatively, a focus on one practice could lead to spread of effective strategies to other practices, which would be highly beneficial. We studied the impact of a colorectal cancer (CRC) screening initiative on delivery of other preventive care measures. METHODS: We used an interrupted time series design with implementation year as the interruption point. The initiative was conducted between 2015 and 2020, with three staggered cohorts. Main outcomes were quality measures for colorectal cancer screening, cervical cancer screening, hypertension management, diabetes management, weight screening and follow-up, tobacco use screening and cessation treatment, and depression screening and follow-up. RESULTS: The initiative was associated with an increase in CRC screening (OR = 1.67, p ≤ 0.01; average marginal effect = 12.2% points), and did not reduce performance on other quality measures in the year of CRC program implementation or a change in their respective secular trends. CONCLUSIONS: The initiative led to a clinically meaningful increase in CRC screening and was not associated with reductions in delivery of six other preventive services. Quality improvement (QI) initiatives typically approach implementation with an eye towards reducing unintended impact and leveraging existing staff and resources. Implementation research studies may benefit from considering how QI initiatives factor in the local context in implementation efforts.

Leveraging an implementation science partnership network to understand how Federally Qualified Health Centers operationalize and address health equity.

Health equity-focused implementation research requires using definitions and approaches that are relevant and meaningful to implementation partners. We examined how health equity was operationalized and addressed at Federally Qualified Health Centers (FQHCs). We conducted semi-structured interviews with leadership (n = 19) and staff (n = 12) at 10 FQHCs in an implementation science partnership network for cancer control equity to understand how they operationalized and addressed health equity. We performed rapid qualitative analysis and shared findings with a larger group of 13 community health centers (including the 10 FQHCs) at an Implementation Learning Community (ILC) to identify action areas for research and practice, followed by a second phase of synthesizing qualitative codes into themes and mapping themes onto a framework for advancing health equity in healthcare organizations. Participants defined health equity as central to the mission of FQHCs, and identified barriers (e.g. financing models) and facilitators (e.g. interpreter services) to advancing health equity at FQHCs. These findings resonated with ILC participants who emphasized the challenge of addressing root cause social determinants of inequities using limited available resources in FQHCs and the importance of developing meaningful collaboration with communities for data collection, data interpretation, data use, and data ownership. Themes captured recommendations to advance health equity in daily work at FQHCs, including investments in staffing, training, and resources. Mapping qualitative themes from health equity-centered interviews with FQHC partners onto a framework for advancing health equity in healthcare organizations can provide clear, context-specific direction for actions aimed at improving health and healthcare equity.

Health equity-focused implementation research requires using definitions and approaches that are relevant and meaningful to implementation partners. Toward this goal, our research team asked leadership and staff at Federally Qualified Health Centers (FQHCs) to share how they defined and addressed health equity at their practice settings. FQHC participants defined health equity as the essential mission of FQHCs as safety net organizations delivering care to medically underserved populations. In addition, key informants identified barriers (e.g. financing models) and facilitators (e.g. interpreter services) to advancing health equity at FQHCs. We presented these findings to a larger group of FQHC stakeholders who recommended that future implementation research and practice consider how FQHCs are challenged to address the root causes of healthcare inequities with limited resources. They also highlighted the importance of meaningful collaboration among researchers, FQHCs, and communities for data collection, data interpretation, data use, and data ownership to advance health equity. Conducting research to understand the perspectives and experiences of FQHC partners can provide clear, context-specific direction for actions to improve health equity and can inform future approaches to health equity-focused implementation research that ismeaningful to FQHC partners and the communities they serve.

Challenges and recommendations for measuring time devoted to implementation and intervention activities in health equity-focused, resource-constrained settings: a qualitative analysis.

BACKGROUND: There is little guidance for conducting health equity-focused economic evaluations of evidence-based practices in resource-constrained settings, particularly with respect to staff time use. Investigators must balance the need for low-touch, non-disruptive cost data collection with the need for data on providing services to priority subpopulations. METHODS: This investigation took place within a pilot study examining the implementation of a bundled screening intervention combining screening for social determinants of health and colorectal cancer at four federally qualified health centers (FQHCs) in the Boston metropolitan area. Methods for collecting data on personnel costs for implementation and intervention activities, including passive (automatic) and active (non-automatic, requiring staff time and effort) data collection, as well as three alternate wordings for self-reporting time-use, were evaluated qualitatively using data collected through interviews with FQHC staff (including clinicians, population health staff, and community health workers) and assessments of data completeness. RESULTS: Passive data collection methods were simple to execute and resulted in no missing data, but missed implementation and intervention activities that took place outside planned meetings. Active cost data collection using spreadsheets was simple for users when applied to care processes already tracked in this fashion and yielded accurate time use data. However, for tasks where this was not typical, and when tasks were broken up over multiple sessions, spreadsheets were more challenging to use. Questions asking about time use for a typical rather than specific time period, and for typical patients, yielded the most reliable and actionable data. Still, even the best-performing question had substantial variability in time use estimates. Participants noted that patient characteristics of interest for equity-focused research, including language spoken, adverse social determinants of health, and issues related to poverty or mental health, all contributed significantly to this variability. CONCLUSIONS: Passively collected time use data are the least burdensome and should be pursued in research efforts when possible, but should be accompanied by qualitative assessments to ensure the data are an accurate reflection of effort. When workflows are already tracked by active data collection, these are also strong data collection methods. Self-reported time use will be most accurate when questions inquire about "typical" tasks and specific types of patients.

Provider beliefs in effectiveness and recommendations for primary HPV testing in 3 health-care systems.

In 2018, the US Preventive Services Task Force endorsed primary human papillomavirus testing (pHPV) for cervical cancer screening. We aimed to describe providers' beliefs about pHPV testing effectiveness and which screening approach they regularly recommend. We invited providers who performed 10 or more cervical cancer screens in 2019 in 3 healthcare systems that had not adopted pHPV testing: Kaiser Permanente Washington, Mass General Brigham, and Parkland Health; 53.7% (501/933) completed the survey between October and December 2020. Response distributions varied across modalities (P < .001), with cytology alone or cotesting being more often viewed as somewhat or very effective for 30- to 65-year-olds compared with pHPV (cytology alone 94.1%, cotesting 96.1%, pHPV 66.0%). In 21- to 29-year-olds, the pattern was similar (cytology alone 92.2%, 64.7% cotesting, 50.8% pHPV). Most providers were either incorrect or unsure of the guideline-recommended screening interval for pHPV. Educational efforts are needed about the relative effectiveness and recommended use of pHPV to promote guideline-concordant care.

Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial.

BACKGROUND: Food insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear. OBJECTIVE: To describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity. METHODS: The Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results. CONCLUSION: Results from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions. CLINICALTRIALS: gov: NCT04828785.

Embedding community-engaged research principles in implementation science: The implementation science center for cancer control equity.

Gaps in the implementation of effective interventions impact nearly all cancer prevention and control strategies in the US including Massachusetts. To close these implementation gaps, evidence-based interventions must be rapidly and equitably implemented in settings serving racially, ethnically, socioeconomically, and geographically diverse populations. This paper provides a brief overview of The Implementation Science Center for Cancer Control Equity (ISCCCE) and describes how we have operationalized our commitment to a robust community-engaged center that aims to close these gaps. We describe how ISCCCE is organized and how the principles of community-engaged research are embedded across the center. Principles of community engagement have been operationalized across all components of ISCCCE. We have intentionally integrated these principles throughout all structures and processes and have developed evaluation strategies to assess whether the quality of our partnerships reflects the principles. ISCCCE is a comprehensive community-engaged infrastructure for studying efficient, pragmatic, and equity-focused implementation and adaptation strategies for cancer prevention in historically and currently disadvantaged communities with built-in methods to evaluate the quality of community engagement. This engaged research center is designed to maximize the impact and relevance of implementation research on cancer control in community health centers.

Implementation of an electronic health record-based care management system to improve tobacco treatment.

BACKGROUND: Tobacco treatment is underused in primary care. We designed a Tobacco Care Management system to increase the delivery of treatment and reduce the burden on primary care providers (PCPs). A one-click functionality added to the electronic health record (EHR) allowed PCPs to refer smokers to a centralized tobacco treatment coordinator (TTC) who called smokers, provided brief counseling, connected them to ongoing treatment and gave feedback to PCPs. OBJECTIVE: To study the system's feasibility and acceptability among PCPs, and its utilization by smokers. DESIGN: Using a mixed methods design, we documented system utilization quantitatively from February 1, 2010 to July 31, 2011, and conducted two focus groups with PCPs in June 2011. PARTICIPANTS: Thirty-six PCPs and 2,894 smokers from two community health centers in Massachusetts. MAIN MEASURES: Quantitative: One-click referral utilization by PCPs, proportion of smokers referred and connected to treatment. Qualitative: PCPs' reasons for use, barriers to use, and experiences with feedback. KEY RESULTS: Twenty-nine PCPs (81 %) used the functionality more than once, generating 466 referrals for 15 % of known smokers seen during the study. The TTC reached 260 (56 %) of the referrals and connected 135 (29 %) to additional treatment. The director of one center sent PCPs monthly feedback about their utilization compared to peers. These PCPs referred a greater proportion of their known smokers (18 % vs. 9 %, p<0.0001) and reported that monthly feedback motivated referrals. PCPs attending focus groups (n=24) appreciated the system's simplicity, access to updated resources, and time-efficient way to address smoking, and wanted more feedback about cessation outcomes. They collectively supported the system's continuation. CONCLUSIONS: A novel EHR-based Tobacco Care Management system was adopted by PCPs, especially those receiving performance feedback, and connected one-third of referred smokers to treatment. The model has the potential to improve the delivery and outcomes of evidence-based tobacco treatment in primary care.

Implementing expanded COVID-19 testing in Massachusetts community health centers through community partnerships: Protocol for an interrupted time series and stepped wedge study design.

BACKGROUND: Community Health Centers (CHCs) are a critical source of care for low-income and non-privately insured populations. During the pandemic, CHCs have leveraged their infrastructure and role as a trusted source of care to engage the communities they serve in COVID-19 testing. METHODS: To directly address the impact that COVID-19 has had on historically marginalized populations in Massachusetts, we designed a study of community-engaged COVID-19 testing expansion: (1) leveraging existing partnerships to accelerate COVID-19 testing and rapidly disseminate effective implementation strategies; (2) incorporating efforts to address key barriers to testing participation in communities at increased risk for COVID-19; (3) further developing partnerships between communities and CHCs to address testing access and disparities; (4) grounding the study in the development of a shared ethical framework for advancing equity in situations of scarcity; and (5) developing mechanisms for communication and science translation to support community outreach. We use a controlled interrupted time series design, comparing number of COVID-19 tests overall and among people identified as members of high-risk groups served by intervention CHCs compared with six matched control CHCs in Massachusetts, followed by a stepped wedge design to pilot test strategies for tailored outreach by CHCs. CONCLUSIONS: Here, we describe a community-partnered strategy to accelerate COVID-19 testing in historically marginalized populations that provides ongoing resources to CHCs for addressing testing needs in their communities. The study aligns with principles of community-engaged research including shared leadership, adequate resources for community partners, and the flexibility to respond to changing needs over time.

An analysis of Liberia's 2007 national health policy: lessons for health systems strengthening and chronic disease care in poor, post-conflict countries.

BACKGROUND: Globally, chronic diseases are responsible for an enormous burden of deaths, disability, and economic loss, yet little is known about the optimal health sector response to chronic diseases in poor, post-conflict countries. Liberia's experience in strengthening health systems and health financing overall, and addressing HIV/AIDS and mental health in particular, provides a relevant case study for international stakeholders and policymakers in other poor, post-conflict countries seeking to understand and prioritize the global response to chronic diseases. METHODS: We conducted a historical review of Liberia's post-conflict policies and their impact on general economic and health indicators, as well as on health systems strengthening and chronic disease care and treatment. Key sources included primary documents from Liberia's Ministry of Health and Social Welfare, published and gray literature, and personal communications from key stakeholders engaged in Liberia's Health Sector Reform. In this case study, we examine the early reconstruction of Liberia's health care system from the end of conflict in 2003 to the present time, highlight challenges and lessons learned from this initial experience, and describe future directions for health systems strengthening and chronic disease care and treatment in Liberia. RESULTS: Six key lessons emerge from this analysis: (i) the 2007 National Health Policy's 'one size fits all' approach met aggregate planning targets but resulted in significant gaps and inefficiencies throughout the system; (ii) the innovative Health Sector Pool Fund proved to be an effective financing mechanism to recruit and align health actors with the 2007 National Health Policy; (iii) a substantial rural health delivery gap remains, but it could be bridged with a robust cadre of community health workers integrated into the primary health care system; (iv) effective strategies for HIV/AIDS care in other settings should be validated in Liberia and adapted for use in other chronic diseases; (v) mental health disorders are extremely prevalent in Liberia and should remain a top chronic disease priority; and (vi) better information systems and data management are needed at all levels of the health system. CONCLUSIONS: The way forward for chronic diseases in Liberia will require an increased emphasis on quality over quantity, better data management to inform rational health sector planning, corrective mechanisms to more efficiently align health infrastructure and personnel with existing needs, and innovative methods to improve long-term retention in care and bridge the rural health delivery gap.

Quit Experiences among Primary Care Patients Enrolled in a Smoking Cessation Pilot RCT Early in the COVID-19 Pandemic.

The impact of the COVID-19 pandemic on US adults' smoking and quitting behaviors is unclear. We explored the impact of COVID-19 on smoking behaviors, risk perceptions, and reactions to text messages during a statewide stay-at-home advisory among primary care patients who were trying to quit. From May-June 2020, we interviewed smokers enrolled in a 12-week, pilot cessation trial providing text messaging and mailed nicotine replacement medication (NCT04020718). Twenty-two individuals (82% white, mean age 55 years), representing 88% of trial participants during the stay-at-home advisory, completed exit interviews; four (18%) of them reported abstinence. Interviews were thematically analyzed by two coders. COVID-19-induced environmental changes had mixed effects, facilitating quitting for some and impeding quitting for others. While stress increased for many, those who quit found ways to cope with stress. Generally, participants felt at risk for COVID-19 complications but not at increased risk of becoming infected. Reactions to COVID-19 and quitting behaviors differed across age groups, older participants reported difficulties coping with isolation (e.g., feeling disappointed when a text message came from the study and not a live person). Findings suggest that cessation interventions addressing stress and boredom are needed during COVID-19, while smokers experiencing isolation may benefit from live-person supports.