Next-Generation Sequencing Trends among Adult Patients with Select Advanced Tumor Types: A Real-World Evidence Evaluation.

There are limited data on the prevalence of next-generation sequencing (NGS) in the United States, especially in light of the increasing importance of identifying actionable oncogenic variants due to molecular biomarker-based therapy approvals. This retrospective study of adult patients with select metastatic solid tumors and central nervous system tumors from the Optum Clinformatics Data Mart US health care claims database (January 1, 2014, to June 30, 2021; N = 63,209) examined NGS use trends over time. A modest increase in NGS was observed across tumor types from 2015 (0.0% to 1.5%) to 2021 (2.1% to 17.4%). A similar increase in NGS rates was also observed across key periods; however, rates in the final key period remained <10% for patients with breast, colorectal, head and neck, soft tissue sarcoma, and thyroid cancers, as well as central nervous system tumors. The median time to NGS from diagnosis was shortest among patients with non-small-cell lung cancer and longest for patients with breast cancer. Predictors of NGS varied by tumor type; test rates for minorities in select tumor types appeared comparable to the White population. Despite improving payer policies to expand coverage of NGS and molecular biomarker-based therapy approvals, NGS rates remained low across tumor types. Given the potential for improved patient outcomes with molecular biomarker-based therapy, further efforts to improve NGS rates are warranted.

Effect of continuity of care on emergency department and hospital visits for obesity-associated chronic conditions: A federated cohort meta-analysis.

BACKGROUND: Obesity-associated chronic conditions (OCC) are prevalent in medically underserved areas of the Southern US. Continuity of care with a primary care provider is associated with reduced preventable healthcare utilization, yet little is known regarding the impact of continuity of care among populations with OCC. This study aimed to examine whether continuity of care protects patients living with OCC and the subgroup with type 2 diabetes (OCC+T2D) from emergency department (ED) and hospitalizations, and whether these effects are modified by race and patient residence in health professional shortage areas (HPSA) METHODS: We conducted a retrospective federated cohort meta-analysis of 2015-2018 data from four large practice-based research networks in the Southern U.S. among adult patients with obesity and one more more additional diagnosed OCC. The outcomes included overall and preventable ED visits and hospitalizations. Continuity of care was assessed at the clinic-level using the Bice-Boxerman Continuity of Care Index RESULTS: A total of 111,437 patients with OCC and 47,071 patients with OCC+T2D from the four large practice-based research networks in the South were included in the meta-analysis. Continuity of Care index varied among sites from a mean (SD) of 0.6 (0.4) to 0.9 (0.2). Meta-analysis demonstrated that, regardless of race or residence in HPSA, continuity of care significantly protected OCC patients from preventable ED visits (IRR:0.95; CI:0.92-0.98) and protected OCC+T2D patients from overall ED visits (IRR:0.92; CI:0.85-0.99), preventable ED visits (IRR:0.95; CI:0.91-0.99), and overall hospitalizations (IRR:0.96; CI:0.93-0.98) CONCLUSION: Improving continuity of care may reduce ED and hospital use for patients with OCC and particularly those with OCC+T2D.

Social determinants of health and adult influenza vaccination: a nationwide claims analysis.

BACKGROUND: The health and economic benefits of the annual influenza vaccine are well documented, yet vaccination rates in the United States missed the Healthy People 2020 goal and remain a focus of Healthy People 2030 efforts. By identifying underlying reasons for low annual influenza vaccination, social elements that need targeting may be identified and could guide future interventions or policy development to achieve vaccination goals and improve overall public health. OBJECTIVE: To determine the influence of certain social determinants of health on adherence to annual influenza vaccination in American adults. METHODS: This was a retrospective cohort analysis using data from IBM MarketScan Commercial Claims and Encounters Database and national Medicare 5% sample data from 2013 to 2016. Study eligibility criteria included adults (aged 18 years and older) who were continuously enrolled for 3 influenza seasons between 2013 and 2016. Receipt of the influenza vaccine was counted over 3 consecutive influenza seasons, and select social determinants were extracted from publicly available sources. Patient characteristics, health resource utilization, and selected social determinants of health were included in bivariate and multivariate logistic regression analyses to determine their association with annual influenza vaccination. RESULTS: 6,694,571 adults across employer-sponsored and Medicare coverage groups were analyzed, of which 14.7% of Medicare-enrolled adults and 9.2% of commercially enrolled adults were vaccinated in all 3 seasons. Higher proportions of vaccine adherence (ie, all 3 seasons) were observed among females (9.6% vs 8.7% [commercial], 15.0% vs 14.4% [Medicare]), the immunocompromised (11.8% vs 8.3% [commercial], 15.9% vs 13.6% [Medicare]), rural residents (10.5% vs 9.0% [commercial], 15.4% vs 14.6% [Medicare]; all P < 0.0001), and those enrolled in a high-deductible health plan (10.3%). Multivariable logistic regression models indicated that the odds of vaccine adherence tended to be higher in areas of higher poverty (OR=1.012; 95% CI = 1.01-1.02 [commercial], OR=1.01; 95% CI = 1.01-1.01 [Medicare]) yet lower in areas with higher proportions of Democratic voters (OR=0.998; 95% CI = 0.998-0.998 [commercial], OR = 0.996; 95% CI = 0.996-0.997 [Medicare]). Among commercially insured adults, the odds of vaccine adherence were higher in areas of higher health literacy (OR=1.036; 95% CI = 1.036-1.037), but this effect was not observed among Medicare members. Conversely, the odds of vaccine adherence increased as the proportion of those residing in areas of limited Internet access increased (OR=1.007; 95% CI = 1.004-1.010) among Medicare members only. CONCLUSIONS: Key social determinants of health are important factors of vaccine adherence and can guide policy and intervention efforts toward addressing potential hesitancy. A deeper assessment of other contributing social factors is needed in seasonal influenza and other vaccines to better interpret the vaccine-seeking behaviors of adults. DISCLOSURES: This study received no outside funding. Gatwood, Hagemann, Hohmeier, and Chiu declare vaccine-related grant funding from Merck & Co. and GlaxoSmithKline for vaccine research unrelated to the current study. Ramachandran declares vaccine-related grant funding from Glaxo-SmithKline for research unrelated to the current study. Shuvo and Behal have nothing to disclose. Findings described in this study were presented as a poster and podium at the Academy of Managed Care Pharmacy Nexus 2020 Virtual meeting, October 19-23, 2020.

Alignment of diagnosis and pharmacy claims data coding of medication adherence among patients with diabetes or hypertension.

BACKGROUND: ICD-10-CM codes exist that facilitate provider designation of patients as "nonadherent to therapy"; however, it is unclear whether this label accurately reflects patient behavior according to widely accepted medication adherence metrics using pharmacy claims data. OBJECTIVE: To determine the extent to which patients are accurately coded for and have calculated rates of nonadherence using ICD-10-CM codes and claims, respectively. METHODS: This was a retrospective cohort study using commercial insurance and Medicare Advantage claims data from 2015 to 2016. The analysis focused on adults aged 18 years and older who had been diagnosed with and were being treated for hypertension and/or diabetes and had been coded as nonadherent by a provider during an outpatient encounter. Adherence (proportion of days covered [PDC]) to oral antihypertensive and/or antidiabetic therapy was calculated 6 months before and after the first nonadherence diagnosis identified in outpatient encounters, using 2 distinct calculation methods. Inferential statistics and multivariable logistic regression were used to determine predictors of coding agreement and changes in adherence after the nonadherence diagnosis controlling for available patient characteristics. RESULTS: A total of 1,142 patients who had been coded as nonadherent were identified, of which between 5.3% and 22.0% (depending on metric and condition) had PDCs before the nonadherence code deeming them adherent according to claims, conflicting with nonadherence diagnosis codes documented by their providers. Mean PDCs increased significantly (20.5%-24.3%, all P < 0.001) among both conditions following the nonadherent code, as did the proportion adherent (PDC > 80%), irrespective of disease (all P < 0.01). The odds of being correctly labeled nonadherent according to claims decreased with age (diabetes odds ratio [OR]: 0.82, 95% CI = 0.694-0.976; hypertension OR: 0.86, 95% CI = 0.773-0.944) but were higher among those taking more medications (diabetes OR: 2.97, 95% CI = 1.658-5.326; hypertension OR: 3.0, 95% CI = 2.095-4.305). Following the nonadherence coding, the odds of being adherent increased with age in both models (diabetes OR: 1.17, 95% CI = 1.012-1.363; hypertension OR: 1.13, 95% CI = 1.048-1.223) yet decreased with increasing medications (diabetes OR: 0.25, 95% CI = 0.138-0.468; hypertension OR: 0.47, 95% CI = 0.368-0.592) and were lower if the patient was observed to be nonadherent before the index encounter (diabetes OR: 0.33, 95% CI = 0.146-0.760; hypertension OR: 0.25, 95% CI = 0.152-0.423). CONCLUSIONS: In general, providers are properly classifying patients as nonadherent using ICD-10-CM codes, but additional assessment is needed to determine the reasons for the remaining mismatch between claims- and diagnosis-based nonadherence. In addition, the correct claims-based metric needs to be established to improve alignment with provider interpretation of patient medication use. DISCLOSURES: No outside funding supported this study. Gatwood reports grants from GlaxoSmithKline, Merck & Co., and AstraZeneca, outside the submitted work. Kovesdy reports consulting fees from Amgen, Sanofi, Fresenius Medical Care, Keryx, Bayer, Abbott, Abbvie, Dr. Schar, Astra-Zeneca, Takeda, Tricida, and Reata and grants from Shire, outside the submitted work. The other authors have nothing to disclose. Findings described in this article were presented as a poster at the American College of Clinical Pharmacy Annual Meeting in New York City, October 2019.

Role of social determinants of health in pneumococcal vaccination among high-risk adults.

OBJECTIVES: To determine the influence of select social determinants of health on uptake of and time to pneumococcal vaccination among those deemed high-risk. METHODS: Using nationwide claims data for years 2013-2016, adult patients (aged 18-64 years) were followed from their first diagnosis for a condition deeming them high-risk for invasive pneumococcal disease through the subsequent 365 days and observed for pneumococcal vaccination in outpatient clinics and pharmacies. Publicly-available data on select social determinants of health were incorporated into analyses, guided by the WHO vaccine hesitancy matrix. Controlling for baseline demographic and clinical characteristics, logistic regression determined predictors of vaccination and a general linear model compared days to being vaccinated. RESULTS: A total of 173,712 patients were analyzed of which approximately one quarter (25.3%) were vaccinated against invasive pneumococcal disease within the first year of being deemed high risk, nearly all of which (98.5%) were received in outpatient clinics. The odds of vaccination were higher among urban residents (OR: 1.18; 95% CI: 1.144-1.223), areas of higher health literacy (OR: 1.02; 95% CI: 1.019-1.025), and more Democratic-voting communities (OR: 1.5; 95% CI: 1.23-1.88). Conversely, the likelihood of vaccination was particularly low in areas of higher poverty (OR: 0.14; 95% CI: 0.068-0.304) and with limited Internet access (OR: 0.14; 95% CI: 0.062-0.305) as well as among adults who did not also get a seasonal influenza vaccine (OR: 0.05; 95% CI: 0.048-0.052). Time to vaccination was longer in rural residents (B = 8.3, p < 0.0001) and communities with less Internet access (B = 75.6, p < 0.001). CONCLUSION: Social determinants may be influencing pneumococcal vaccine-seeking behavior among those deemed high-risk, but a more formal and comprehensive framework must be assessed to determine the full impact of these factors across vaccines recommended in adults.

The role of social determinants in timely herpes zoster vaccination among older American adults.

CDC recommends that U.S. adults ≥50 years receive the herpes zoster (HZ) vaccine; but few are vaccinated at the recommended age. Little is known about how social determinants of health (SDH) influence timely vaccination. This retrospective observational study included U.S. adults aged ≥50 years who were vaccinated against HZ between 2014 and 2016 from IBM MarketScan commercial claims and Medicare supplemental databases. The cohort was classified into three groups based on age of vaccination: earlier (50-59 years), timely (60-64 years), and later (65+ years). Select SDH data from publicly-available sources were linked and included in multinomial logistic regression assessing the impact of SDH on timely vaccination. The final cohort comprised 549,544 individuals, 49.5% of whom were vaccinated at the age of 60-64. Odds of later HZ vaccination increased with higher poverty (OR: 1.035, 95% CI: 1.031-1.038), more democratic voters (OR: 1.011, 95% CI: 1.010-1.012), and lack of Internet access (OR: 1.028, 95% CI: 1.024-1.032), but decreased with higher health literacy (OR: 0.971, 95% CI: 0.970-0.973). Conversely, higher health literacy and lower poverty were associated with higher odds of earlier vaccination. Being male, not receiving a seasonal influenza vaccine, and higher healthcare utilization were associated with later vaccination. Individuals on an EPO/PPO vs. HMO plan, or who resided in regions other than the Northeast were more likely to receive the vaccine earlier. This study demonstrates the influence of SDH on time of HZ vaccination, but further research is needed to fully understand the impact of SDH on vaccination.

Continuity of Care for Patients with Obesity-Associated Chronic Conditions: Protocol for a Multisite Retrospective Cohort Study.

BACKGROUND: Obesity affects nearly half of adults in the United States and is contributing substantially to a pandemic of obesity-associated chronic conditions such as type 2 diabetes, hypertension, and arthritis. The obesity-associated chronic condition pandemic is particularly severe in low-income, medically underserved, predominantly African-American areas in the southern United States. Little is known regarding the impact of geographic, income, and racial disparities in continuity of care on major health outcomes for patients with obesity-associated chronic conditions. OBJECTIVE: The aim of this study is to assess, among patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes, (1) whether continuity of care is associated with lower overall and potentially preventable emergency department and hospital utilization, (2) the effect of geographic, income, and racial disparities on continuity of care and on health care utilization, (3) whether continuity of care particularly protects individuals at risk for disparities from adverse health outcomes, and (4) whether characteristics of health systems are associated with higher continuity of care and better outcomes. METHODS: Using 2015-2018 data from 4 practice-based research networks participating in the Southern Obesity and Diabetes Coalition, we will conduct a retrospective cohort analysis and distributed meta-analysis. Patients with obesity-associated chronic conditions and with type 2 diabetes will be assessed within each health system, following a standardized study protocol. The primary study outcomes are overall and preventable emergency department visits and hospitalizations. Continuity of care will be calculated at the facility level using a modified version of the Bice-Boxerman continuity of care index. Race will be assessed using electronic medical record data. Residence in a low-income area or a health professional shortage area respectively will be assessed by linking patient residence ZIP codes to the Centers for Medicare & Medicaid Services database. RESULTS: In 4 regional health systems across Tennessee, Mississippi, Louisiana, and Arkansas, a total of 53 adult hospitals were included in the study. A total of 147,889 patients with obesity-associated chronic conditions who met study criteria were identified in these health systems, of which 45,453 patients met the type 2 diabetes criteria for inclusion. Results are expected by the end of 2020. CONCLUSIONS: This study should reveal whether health system efforts to increase continuity of care for patients with obesity and diabetes have potential to improve outcomes and reduce costs. Analyzing disparities in continuity of care and their effect on major health outcomes can help demonstrate how to improve care and use of health care resources for vulnerable patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes. Better understanding of the association between continuity and health care utilization for these vulnerable populations will contribute to the development of higher-value health systems in the southern United States. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20788.

A mid-South chronic disease registry and practice-based research network to address disparities.

OBJECTIVES: To describe an innovative health information technology (HIT) model for supporting community-wide health improvement through multiprovider collaboration in a regional population health registry and practice-based research network (PBRN). STUDY DESIGN: Case study. METHODS: We describe the HIT data structure and governance of the Diabetes Wellness and Prevention Coalition (DWPC) Registry and PBRN based in Memphis, Tennessee. The population served and their characteristics were assessed for all adult patients with at least 1 encounter in a participating health care delivery system from January 1, 2013, to March 31, 2019. Disparities in access and health care utilization were assessed by residential zip code. RESULTS: The DWPC Registry is a chronic disease and population health data warehouse designed to facilitate chronic disease surveillance and tracking of processes and outcomes of care in medically underserved areas of the mid-South. The Registry primarily focuses on obesity-associated chronic conditions such as diabetes, hypertension, hyperlipidemia, and chronic kidney disease. It combines patient data from 7 regional health systems, which include 6 adult hospitals and more than 50 outpatient practices, covering 462,223 adults with 2,032,425 clinic visits and 602,679 hospitalizations and/or emergency department visits from January 1, 2013, to March 31, 2019. The most prevalent chronic conditions include obesity (37.2%), hypertension (34.4%), overweight (26.4%), hyperlipidemia (18.0%), and type 2 diabetes (14.0%). The Registry provides quarterly practice improvement reports to participating clinics, facilitates surveillance of and outreach to patients with unmet health needs, and supports a pragmatic clinical trial and multiple cohort studies. CONCLUSIONS: Regional registries and PBRNs are powerful tools that can support real-world quality improvement and population health efforts to reduce disparities and improve equity in chronic disease care in medically underserved communities across the United States.

The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.

Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.

Pneumococcal vaccination in older adults: An initial analysis of social determinants of health and vaccine uptake.

OBJECTIVES: To examine the potential influence of social determinants of health on pneumococcal vaccination in older American adults. METHODS: This study used nationwide, US Medicare claims data from 2013 to 2016 to assess uptake of pneumococcal vaccination among adults in the first year after turning age 65. Patients were followed from the point of being 65 years of age and initially enrolled in traditional fee-for-service Medicare or a Medicare Advantage plan through the subsequent year and observed for pneumococcal vaccination in outpatient clinics and pharmacies. Publicly-available data on select social determinants of health were incorporated and guided by the World Health Organization vaccine hesitancy matrix. Logistic regression determined predictors of vaccination while controlling clinical and demographic characteristics. RESULTS: A total of 307,488 and 74,995 adults aged 65 years were identified from Medicare Advantage and Medicare fee-for-service claims, respectively, and 21.1% of Medicare Advantage and 38.2% of Medicare fee-for-service patients received a pneumococcal vaccine in the first year after turning 65. Those residing in urban areas had a higher likelihood of pneumococcal vaccination in both the Medicare Advantage (OR: 1.31; 95% CI: 1.267-1.344) and Medicare fee-for-service (OR: 1.53; 95% CI: 1.450-1.615) cohorts. Additionally, residing in areas of higher health literacy or communities with more democratic voters were consistently associated with a higher odds of pneumococcal vaccination regardless of Medicare type. Results also pointed to a synergistic relationship between receiving the influenza vaccine and also being vaccinated against pneumococcal disease. CONCLUSION: Social determinants of health, including local health literacy, poverty, residing in more liberal areas, and access to information, may be influencing the pneumococcal vaccine-related decisions of older adults. However, additional factors associated with the vaccine hesitancy matrix and more granular data (e.g., zip code-level) are needed to fully determine the impact in this and other vaccines recommended in older adults.

Can primary care access reduce health care utilization for patients with obesity-associated chronic conditions in medically underserved areas?

OBJECTIVES: The prevalence and burdens of obesity-associated chronic conditions (OCC) are rising nationwide, particularly in health professional shortage areas (HPSA). This study examined the impact of access to primary care on health care utilization for vulnerable populations with OCC in the South. METHODS: Adult patients with obesity (BMI ≥ 30 kg/m2 ), greater than or equal to one additional OCC, and self-reported primary care access data were retrospectively identified from hospital and emergency department (ED) electronic medical records of a major health care system in the South. Multivariable logistic regression assessed factors associated with self-reported access to primary care. Multivariable zero-inflated negative binomial models assessed effect of HPSA residence on relationships between self-reported access to primary care and health care utilization. RESULTS: A total of 29 674 patients were identified. Hypertension (76.1%), type 2 diabetes mellitus (34.1%), and hyperlipidemia (32.9%) were the most prevalent OCC. Males (odds ratio [OR]: 0.43; 95% confidence interval [CI], 0.40-0.47), unmarried (OR: 0.69; 95% CI, 0.63-0.76), and uninsured (OR: 0.29; 95% CI, 0.27-0.32) had lower odds of access to primary care. For patients living in HPSA (vs non-HPSA), access to primary care was associated with higher incidence of overall ED use (relative risk [RR]: 1.38; 95% CI, 1.19-1.61) and lower incidence of potentially preventable hospital use (RR: 0.59; 95% CI, 0.38-0.92). CONCLUSION: Paradoxically, access to primary care may increase ED use while reducing potentially preventable hospital utilization for patients with OCC in HPSA. Increasing access to primary care alone, without strengthening its capacity to serve the needs of vulnerable patients, may be insufficient to reduce hospital utilization.

The Management of Diabetes in Everyday Life (MODEL) program: development of a tailored text message intervention to improve diabetes self-care activities among underserved African-American adults.

Tailoring health-related materials is an effective mechanism to encourage behavior change; however, little research has described processes and critical characteristics for effective tailoring in underserved populations. The purpose of this study is to describe a process using input from content experts and lay patient advisors to tailor text messages focused on improving self-care behaviors of African-American adults with diabetes and identify characteristics of messages perceived to be most effective. An initial library of tailorable messages was created using theory-based approaches, expert opinion, and publicly available materials. A study-specific advisory council representing the program's intended population provided sequential individual and focus group review of a sample of draft messages focused on medication use, healthy eating, and physical activity. Messages were reviewed for content, tone, and applicability to African-American adults with diabetes from underserved communities. Based on this feedback, messages were revised and a final library of tailorable messages was constructed for use in a text messaging intervention. The initial library had over 5,000 tailorable messages. Participants preferred messages that included: (1) encouraging statements without condescension; (2) short sentences in lay language; (3) specific, actionable instructions; and (4) content relatable to daily activities of living. When possible, messages with similar themes should be repeated over short periods of time to improve the odds of material being absorbed and action being taken. Input from patient participants and advisors is essential for designing deeply tailored messages that honor the preferences, values, and norms of the population under study and promote health behavior change. TRIAL REGISTRATION: NCT02957513.