Prevalence of opioid and nonopioid pain management therapies among Medicare beneficiaries with musculoskeletal pain conditions from 2016 to 2019.

INTRODUCTION: Pain treatment guidelines prioritize nonopioid therapies over opioid medications to prevent opioid-related harms. We examined trends in receipt and intensity of nonpharmacologic, nonopioid medication, and opioid therapies among Medicare beneficiaries. METHODS: Using a 20% national random sample of Medicare data from 2016 to 2019, we identified fee-for-service beneficiaries with ≥2 diagnoses of back, neck, fibromyalgia, or osteoarthritis/joint pain annually. We excluded beneficiaries with cancer. We calculated annual proportions of beneficiaries who received physical therapy (PT), chiropractic care, gabapentin, and opioids, overall and in demographic, geographic, and clinical subgroups. We estimated the intensity of therapies using the annual number of visitsor prescription fills, prescription days' supply, and opioid dose. RESULTS: During 2016-2019, PT receipt increased (22.8% to 25.5%) and the mean number of visits among recipients of PT went from 12 to 13. Chiropractic receipt (~18%) and mean annual visits (~10) remained unchanged. The prevalence of gabapentin receipt was stable at ~22% and the mean annual number of fills was unchanged though gabapentin days increased slightly. Opioid prescribing decreased (56.7% to 46.5%) and reductions in opioid dose and duration were observed. Opioid receipt was high among beneficiaries who were under 65 years, American Indian/Alaska Native, Black/African American, or had opioid use disorder (OUD), in whom nonpharmacologic therapies were also received the least. CONCLUSION: Utilization of nonopioid therapies lagged opioids among Medicare beneficiaries with musculoskeletal pain, with limited changes from 2016 to 2019. As opioid prescribing declines and alternative pain therapy receipt remains low, there are potential increasing risks of pain going untreated or undertreated and individuals seeking illicit opioids to alleviate their pain.

Initial treatment approaches and healthcare utilization among veterans with low back pain: a propensity score analysis.

BACKGROUND: Opioid prescriptions for Veterans with low back pain (LBP) persist despite the availability of PT, a lower medical risk treatment option. Patterns of treatment and subsequent healthcare utilization for Veterans with LBP are unknown. The purpose of this study was to evaluate the association of physical therapy (PT) and opioids and outcomes of spinal surgery and chronic opioid use for Veterans with incident LBP. METHODS: We conducted a retrospective cohort study identifying Veterans with a new diagnosis of LBP using ICD codes from the Veterans Administration national database from 2012 to 2017. Veterans were classified into three treatment groups based on the first treatment received within 30 days of incident LBP: receipt of PT, opioids, or neither PT nor opioids. Outcomes, events of spinal surgery and chronic opioid use, were identified beginning on day 31 up to one year following initial treatment. We used propensity score matching to account for the potential selection bias in evaluating the associations between initial treatment and outcomes. RESULTS: There were 373,717 incident cases of LBP between 2012 and 2017. Of those 28,850 (7.7%) received PT, 48,978 (13.1%) received opioids, and 295,889 (79.2%) received neither PT or opioids. Pain, marital status and the presence of cardiovascular, pulmonary, or metabolic chronic conditions had the strongest statistically significant differences between treatment groups. Veterans receiving opioids compared to no treatment had higher odds of having a spinal surgery (2.04, 99% CI: 1.67, 2.49) and progressing to chronic opioid use (11.8, 99% CI: 11.3, 12.3). Compared to Veterans receiving PT those receiving opioids had higher odds (1.69, 99% CI: 1.21, 2.37) of having spinal surgery and progressing to chronic opioid use (17.8, 99% CI: 16.0, 19.9). CONCLUSION: Initiating treatment with opioids compared to PT was associated with higher odds of spinal surgery and chronic opioid use for Veterans with incident LBP. More Veterans received opioids compared to PT as an initial treatment for incident LBP. Our findings can inform rehabilitation care practices for Veterans with incident LBP.

The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial.

Importance: Tobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries. Objective: To evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco. Design, Setting, and Participants: In Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021. Interventions: At bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medical staff provided opt-out patients with inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls. Patients could opt out of any or all elements of care. Opt-in patients willing to quit were offered each element of treatment described previously. Opt-in patients who were unwilling to quit received motivational counseling. Main Outcomes and Measures: The main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization. Results: Of a total of 1000 eligible adult patients who were randomized, most consented and enrolled (270 [78%] of opt-in patients; 469 [73%] of opt-out patients). Adaptive randomization assigned 345 (64%) to the opt-out group and 645 (36%) to the opt-in group. The mean (SD) age at enrollment was 51.70 (14.56) for opt-out patients and 51.21 (14.80) for opt-out patients. Of 270 opt-in patients, 123 (45.56%) were female, and of 469 opt-out patients, 226 (48.19%) were female. Verified quit rates for the opt-out group vs the opt-in group were 22% vs 16% at month 1 and 19% vs 18% at 6 months. The Bayesian posterior probability that opt-out care was better than opt-in care was 0.97 at 1 month and 0.59 at 6 months. Treatment use for the opt-out group vs the opt-in group was 60% vs 34% for postdischarge cessation medication (bayesian posterior probability of 1.0), and 89% vs 37% for completing at least 1 postdischarge counseling call (bayesian posterior probability of 1.0). The incremental cost-effectiveness ratio was $678.60, representing the cost of each additional quit in the opt-out group. Conclusions and Relevance: In this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients' sense of agency and alliance with practitioners. Stronger and longer treatment could increase cessation. Trial Registration: ClinicalTrials.gov Identifier: NCT02721082.

Two decade trends in cardiovascular disease outcomes and cardiovascular risk factors among US veterans living with HIV.

Coomprhensive data on temporal trends in cardiovascular disease (CVD) risk factors and outcomes in people living with HIV are limited. Using retrospective data on 50,284 US Veterans living with HIV (VLWH) who received care in the VA from 2001 to 2019, we calculated the prevalence and incidence estimates of CVD risk factors and outcomes, as well as the average annual percent changes (AAPC) in the estimates. The mean age of the Veterans increased from 47.8 (9.1) years to 58.0 (12.4) years during the study period. The population remained predominantly (>95%) male and majority Black (∼50%). The prevalence of the CVD outcomes increased progressively over the study period: coronary artery disease (3.9%-18.7%), peripheral artery disease (2.3%, 10.3%), ischemic cerebrovascular disease (1.1%-9.9%), and heart failure (2.4%-10.5%). There was a progressive increase in risk factor burden, except for smoking which declined after 2015. The AAPC in prevalence was statistically significant for the CVD outcomes and risk factors. When adjusted for age, the predicted prevalence of CVD risk factors and outcomes showed comparable (but attenuated) trends. There was generally a comparable (but attenuated) trend in incidence of CVD outcomes, procedures, and risk factors over the study period. The use of statins increased from 10.6% (2001) to 40.8% (2019). Antiretroviral therapy usage increased from 77.7% (2001) to 85.0% (2019). In conclusion, in a retrospective analysis of large-scale VA data we found the burden and incidence of several CVD risk factors and outcomes have increased among VLWH over the past 20 years.

Age Modifies Intracranial and Gastrointestinal Bleeding Risk from P2Y12 Inhibitors in Patients Receiving Dialysis.

Background: Individuals aged ≥75 years are the fastest-growing population starting dialysis for end-stage kidney disease (ESKD) due to living longer with coronary artery disease. ESKD alone can increase bleeding risk, but P2Y12 inhibitor (P2Y12-I) antiplatelet medications prescribed for cardiovascular treatment can exacerbate this risk in patients with ESKD. The age-specific rates of bleeding complications in dialysis patients with ESKD on P2Y12-I remain unclear, as does how age modifies the bleeding risk from P2Y12-I use in these patients. Methods: In a retrospective cohort study, we collected data on 40,972 patients receiving maintenance hemo- or peritoneal dialysis who were newly prescribed P2Y12-I therapy between 2011 and 2015 from the USRDS registry. We analyzed the effect of age on the time to first bleed and the interactions between age and P2Y12-I type on modifying the effects of a bleed. Results: Twenty percent of the cohort were aged ≥75 years. There were 3096 (8%) gastrointestinal (GI) and 1298 (3%) intracranial (IC) bleeding events during a median follow-up of 1 year. Annual incidence rates for IC bleeds were 2% in those aged <55 years and 3% in those aged ≥75 years. Rates for GI bleeds were 4% in those aged <55 years and 9% in those aged ≥75 years. On clopidogrel, prasugrel, and ticagrelor, for every decade increase in age of the cohort members, the risk of IC bleed increased by 9%, 55%, and 59%, and the risk of GI bleed increased by 21%, 28%, and 39%, respectively. At age ≥75 years, prasugrel was associated with a greater risk of IC bleed than clopidogrel. At age ≥60 years, ticagrelor was associated with a greater risk of GI bleed than clopidogrel. Conclusions: More potent P2Y12-Is (prasugrel and ticagrelor) were associated with a disproportionately higher risk of IC bleed with increasing age compared with that of clopidogrel-prasugrel was much worse than clopidogrel at age ≥75 years. All three drugs were associated with only modest increase in the risk of GI bleed with every decade increase in age-ticagrelor was much worse than clopidogrel at ≥60 years of age. These results highlight the need for head-to-head clinical trials for the use of P2Y12-Is in patients with ESKD to determine age cutoffs where the risk of bleeding outweighs the benefits of thrombosis prevention.

Nonpharmacologic management of chronic pain in the United States' Medicare population: a scoping review protocol.

OBJECTIVE: This objective of this review is to describe the scope of the literature on the access to and use of nonpharmacologic therapies to manage chronic pain among people with disabilities and older adults. INTRODUCTION: Clinical guidelines recommend nonpharmacologic interventions as first-line therapy for chronic pain management. The importance of nonpharmacologic management is magnified in populations with a high pain burden and multiple chronic conditions, such as people living with a disability and/or older adults, many of whom are enrolled in Medicare. Understanding the utilization of nonpharmacologic therapies for pain is critical to guide effective pain management delivery and policy. INCLUSION CRITERIA: This scoping review will consider studies of Medicare beneficiaries and Medicare-eligible individuals who have chronic pain. Noninvasive and nonpharmacologic treatments for pain identified in clinical guidelines will be included. We will exclude studies exclusively focused on acute pain, cancer pain, palliative care and hospice settings, cannabis-based treatment, and pharmacologic therapies. Studies conducted outside the United States will be excluded. METHODS: The proposed scoping review will be conducted in accordance with JBI methodology. The search strategy has been developed in consultation with a public health librarian and will be carried out in MEDLINE, CINAHL, and SocINDEX, Web of Science, and the Cochrane Library. The search will be limited to results published in English since January 1, 1990. Two independent reviewers will screen all titles and abstracts and then full-text articles. Data will be extracted and summarized in diagrammatic, tabular, and narrative formats. SCOPING REVIEW REGISTRATION: Open Science Framework ( https://osf.io/h7bwc/ ).

Age at Diagnosis of Heart Failure in United States Veterans With and Without HIV Infection.

Background Although HIV is associated with increased risk of heart failure (HF), it is not known if people living with HIV develop HF at a younger age compared with individuals without HIV. Crude comparisons of age at diagnosis of HF between individuals with and without HIV does not account for differences in underlying age structures between the populations. Methods and Results We used Veterans Health Administration data to compare the age at HF diagnosis between veterans with and without HIV, with adjustment for difference in population age structure. Statistical weights, calculated for each 1-year strata of veterans with HIV in each calendar year from 2000 to 2018, were applied to the veterans without HIV to standardize the age structure. We identified 5093 veterans with HIV (98% men, 34% White) with first HF episode recorded after HIV diagnosis (median age at incidence of HF, 58 years), and 1 425 987 veterans without HIV (98% men, 78% White) with HF (corresponding age, 72 years), with an absolute difference of 14 years. After accounting for difference in age structure, the adjusted median age at HF diagnosis for veterans without HIV was 63 years, 5 years difference with veterans with HIV (P<0.001). The age differences were consistent across important subgroups such as preserved versus reduced ejection fraction and inpatient versus outpatient index HF. Conclusions Veterans with HIV are diagnosed with HF at a significantly younger age compared with veterans without HIV. These findings may have implications for HF prevention in individuals with HIV. Future studies are needed to make the findings more generalizable.

Prevalence and Co-occurrence of Alcohol, Nicotine, and Other Substance Use Disorder Diagnoses Among US Transgender and Cisgender Adults.

Importance: Substance use disorders are a major source of morbidity and mortality in the United States. National data comparing the prevalence of substance use disorder diagnoses (SUDDs) among transgender and cisgender individuals are lacking in the United States. Objectives: To investigate the prevalence of SUDDs among transgender and cisgender adults and to identify within-group and between-group differences by age, gender, and geographic location. Design, Setting, and Participants: This cross-sectional study used the OptumLabs Data Warehouse to analyze deidentified claims from approximately 74 million adults aged 18 years or older enrolled in commercial or Medicare Advantage insurance plans in 2017. A total of 15 637 transgender adults were identified based on a previously developed algorithm using a combination of International Classification of Diseases, Tenth Revision (ICD-10) transgender-related diagnosis and procedure codes and sex-discordant hormone prescriptions. A cohort of 46 911 cisgender adults was matched to the transgender cohort in a 3:1 ratio based on age and geographic location. Main Outcomes and Measures: SUDDs, based on ICD-10 codes, were assessed overall and compared between transgender and cisgender cohorts and by geographic region (ie, Northeast, Midwest, South, and West); age groups (eg, 18-25, 26-30, 31-35 years), and gender (ie, transfeminine [TF; assigned male sex at birth, identify along feminine gender spectrum], transmasculine [TM; assigned female sex at birth, identify along masculine gender spectrum], male, and female). Results: In this study of 15 637 transgender adults (4955 [31.7%] TM) and 46 911 cisgender adults (23 247 [50.4%] men), most (8627 transgender adults [55.2%]; 51 762 cisgender adults [55.2%]) were aged between 18 and 40 years, and 6482 transgender adults (41.5%) and 19 446 cisgender adults (41.5%) lived in the South. Comparing transgender to cisgender groups, significant differences were found in the prevalence of a nicotine (2594 [16.6%] vs 2551 [5.4%]; P < .001), alcohol (401 [2.6%] vs 438 [0.9%]; P < .001), and drug (678 [4.3%] vs 549 [1.2%]; P < .001) SUDDs. Among transgender adults, cannabis was the most prevalent drug SUDD (321 [2.1%]), followed by opioid SUDD (205 [1.3%]) and cocaine SUDD (81 [0.5%]), whereas among cisgender adults, cannabis and opioid SUDDs were equally prevalent (cannabis, 186 [0.4%]; opioid, 207 [0.4%]), followed by cocaine SUDD (59 [0.1%]). Conclusions and Relevance: In this study, the prevalence of SUDDs was significantly elevated among transgender adults relative to their cisgender peers. These findings underscore the need for culturally tailored clinical interventions to treat substance use disorder in transgender populations.

Hazard of Cervical, Oropharyngeal, and Anal Cancers in HIV-Infected and HIV-Uninfected Medicaid Beneficiaries.

BACKGROUND: Human immunodeficiency virus-infected (HIV+) individuals are disproportionately at risk for human papillomavirus (HPV)-associated cancers, but the magnitude of risk estimates varies widely. We conducted a retrospective study using a large U.S.-based cohort to describe the relationship between HIV infection and incident cervical, oropharyngeal, and anal cancers. METHODS: Using 2001-2012 U.S. Medicaid data from 14 states, we matched one HIV+ to three HIV-uninfected (HIV-) enrollees on sex, race, state, age, and year, and followed persons for up to 10 years. We developed Cox proportional hazards models comparing HIV+ to HIV- for time to cancer diagnosis adjusted for demographic and comorbidity attributes. RESULTS: Our cohorts included 443,592 women for the cervical cancer analysis, and 907,348 and 906,616 persons for the oropharyngeal and anal cancer analyses. The cervical cancer cohort had a mean age of 39 years and was 55% Black. The oropharyngeal and anal cancer cohorts were 50% male, had a mean age of 41 years, and were 51% Black. We estimated the following HRs: cervical cancer, 3.27 [95% confidence interval (CI), 2.82-3.80]; oropharyngeal cancer, 1.90 (95% CI, 1.62-2.23; both sexes), 1.69 (95% CI, 1.39-2.04; males), and 2.55 (95% CI, 1.86-3.50; females); and anal cancer, 18.42 (95% CI, 14.65-23.16; both sexes), 20.73 (95% CI, 15.60-27.56; males), and 12.88 (95% CI, 8.69-19.07; females). CONCLUSIONS: HIV+ persons were at an elevated risk for HPV-associated cancers, especially anal cancer. IMPACT: Medicaid claims data corroborate previous estimates based on registries and clinical cohorts.

Heart Failure Outcomes and Associated Factors Among Veterans With Human Immunodeficiency Virus Infection.

OBJECTIVES: This study sought to investigate outcomes of heart failure (HF) in veterans living with human immunodeficiency virus (HIV). BACKGROUND: Data on outcomes of HF among people living with human immunodeficiency virus (PLHIV) are limited. METHODS: We performed a retrospective cohort study of Veterans Health Affairs data to investigate outcomes of HF in PLHIV. We identified 5,747 HIV+ veterans with diagnosis of HF from 2000 to 2018 and 33,497 HIV- frequency-matched controls were included. Clinical outcomes included all-cause mortality, HF hospital admission, and all-cause hospital admission. RESULTS: Compared with HIV- veterans with HF, HIV+ veterans with HF were more likely to be black (56% vs. 14%), be smokers (52% vs. 29%), use alcohol (32% vs. 13%) or drugs (37% vs. 8%), and have a higher comorbidity burden (Elixhauser comorbidity index 5.1 vs. 2.6). The mean ejection fraction (EF) (45 ± 16%) was comparable between HIV+ and HIV- veterans. HIV+ veterans with HF had a higher age-, sex-, and race-adjusted 1-year all-cause mortality (30.7% vs. 20.3%), HF hospital admission (21.2% vs. 18.0%), and all-cause admission (50.2% vs. 38.5%) rates. Among veterans with HIV and HF, those with low CD4 count (<200 cells/ml) and high HIV viral load (>75 copies/µl) had worse outcomes. The associations remained statistically significant after adjusting for extensive list of covariates. The incidence of all-cause mortality and HF admissions was higher among HIV+ veterans with ejection fraction <45% CONCLUSIONS: HIV+ veterans with HF had higher risk of hospitalization and mortality compared with their HIV- counterparts, with worse outcomes reported for individuals with lower CD4 count, higher viral load, and lower ejection fraction.

Trends for and Clinical Factors Associated with Choice of Oral P2Y12 Inhibitors for Patients on Chronic Dialysis.

BACKGROUND: Trends and clinical factors associated with prescribing choices for oral P2Y12 inhibitors (P2Y12-I) remain unknown for patients on chronic dialysis, i.e., with end-stage renal disease (ESRD). METHODS: From 2011-2014 U.S. Renal Data System registry, we identified 36,542 ESRD patients who received new prescriptions for P2Y12-I (median age 64.0 years and 54% males). Of the cohort, 93% were receiving hemodialysis and 7% on peritoneal dialysis. We analyzed trends and investigated clinical factors associated with specific P2Y12-I prescribed. RESULTS: Clopidogrel was prescribed for 95%, prasugrel for 3%, and ticagrelor for 2%. Clopidogrel was favored for those ≥75 years (18% of cohort). Compared to Caucasians, African Americans (36% of cohort) and Hispanics (19% of cohort) were less likely to receive prasugrel and ticagrelor (P<0.05). Patients receiving hemodialysis versus peritoneal dialysis were less likely to receive prasugrel over clopidogrel, adjusted odds ratio (aOR) 0.67 (0.55-0.82). Each additional year of dialysis decreased the odds of receiving prasugrel over clopidogrel, aOR 0.91 (0.85-0.98). History of atrial fibrillation reduced the odds of receiving ticagrelor or prasugrel over clopidogrel, aOR 0.69 (0.54-0.89) and 0.73 (0.60-0.89), respectively. Concomitant oral anticoagulant use was not associated with choice of P2Y12-I. Occurrence of non-ST segment elevation myocardial infarction or percutaneous coronary intervention within the 6-month period prior to the index date favored ticagrelor over prasugrel, aOR 1.31 (1.06-1.62) and 1.29 (1.01-1.66), respectively. However, prescribing trends favoring ticagrelor over prasugrel were not observed for deployment of drug-eluting, or multiple coronary stents. CONCLUSION: Between 2011 and 2014, clopidogrel remained the most common P2Y12-I whereas ticagrelor and prasugrel remained underutilized in ESRD patients. Prescribing practices for these drugs were based upon clinically approved indication for their use in the general population as well as perceived complexity of an ESRD patient including demographics, dialysis-related factors and comorbidities. Comparative effectiveness studies involving ESRD patients are needed to prove that ticagrelor and prasugrel are just as safe and effective as clopidogrel before clinicians can make informed decisions for choice of P2Y12-I in this patient population.

Community-Clinical Linkage Intervention to Improve Colorectal Cancer Screening Among Underserved Korean Americans.

Korean Americans report the lowest and declined rates of colorectal cancer (CRC) screening, compared to general population in the United States. The present study aimed to evaluate the efficacy of a community-based multifaceted intervention designed to improve CRC screening among Korean Americans. A cluster-randomized trial involving 30 Korean church-based community organizations (n = 925) was conducted. Fifteen churches were assigned to intervention (n=470) and the other 15 to control (n = 455) groups. Main components of the intervention included interactive group education, patient navigation, physician engagement, and provision of fecal immunochemical test (FIT) kit. CRC screening rates were assessed at a 12-month follow-up. Participants in the intervention group were significantly more likely to receive CRC screening (69.3%) as compared with those in the control group (16%). The intervention was particularly effective in promoting FIT among the more disadvantaged individuals in the Korean American community. Regression analysis revealed that controlling for the intervention effect, male gender, high school education, annual income of $20,000-40,000 were significantly associated with increased screening by FIT, whereas English inefficiency was significantly and lack of health insurance was marginally significantly associated with decreased screening by colonoscopy/sigmoidoscopy. Culturally and linguistically appropriate multifaceted intervention combining FIT provision with community-clinical linkage has a potential to be a cost-effective and practical approach to effectively targeting hard-to-reach disadvantaged minority populations and enhance CRC screening to reduce cancer disparities.

Application of risk factors for venous thromboembolism in patients with multiple myeloma starting chemotherapy, a real-world evaluation.

INTRODUCTION: Within the first year of diagnosis, up to 1 in 3 multiple myeloma (MM) patients will experience a venous thromboembolism (VTE). The International Myeloma Working Group (IMWG) has thromboprophylaxis guidelines that stratify patients into low or high risk for thrombosis and subsequently recommend thromboprophylaxis, but it is unknown if these recommendations are being followed or if they are effective. The purpose of this study was to assess efficacy of the IMWG guidelines and investigate other potential VTE risk factors. METHODS: Study participants were treated at the University of Kansas Medical Center between 2007 and 2013, and charts were reviewed to extract data. Cases (MM and VTE) were matched to controls (MM and no VTE) at approximately 1:3 ratio based on gender, age (±5 years), and time of MM diagnosis (±5 years). RESULTS: A total of 80 cases and 211 controls were matched. Most patients (82%) were considered high risk for experiencing a VTE at the time of their MM diagnosis and 18% were considered low risk. Neither risk category (P = 0.16) nor thromboprophylaxis at baseline (P = 0.37) predicted VTE, though cases were more likely than controls to have an increased risk of thrombosis at the time of clot compared to their baseline risk (P = 0.09). CONCLUSION: Our results suggest that IMWG guidelines are not being consistently followed and therefore could not be validated. Additional risk factors were not identified, but risk for VTE may change over time suggesting patients may require ongoing assessment of VTE risk and thromboprophylaxis throughout the disease course.

Efficacy of a community-based participatory and multilevel intervention to enhance hepatitis B virus screening and vaccination in underserved Korean Americans.

BACKGROUND: The primary objective of the current study was to evaluate the efficacy of a community-based participatory intervention program in improving hepatitis B virus (HBV) screening and vaccination among Korean Americans who were not previously screened. METHODS: A cluster randomized trial involving 32 Korean church-based community organizations (1834 participants) was conducted. Sixteen churches were randomly assigned to an HBV screening and vaccination multicomponent intervention condition (972 participants) and 16 were assigned to a general cancer education control condition (862 participants). The main components of the intervention program included interactive group education; patient navigation; and the engagement of health care providers, church leadership, and church members in the medical field. The application of community-based participatory research principles was monitored and evaluated. HBV screening and vaccination rates (self-reported and medical record verification) were assessed at 6-month and 12-month follow-ups, respectively. RESULTS: The results of the current study demonstrated significant efficacy in the HBV screening rate (92.5% in the intervention group vs 5.5% in the control group), 3-series HBV vaccination completion rate (84% in the intervention group vs 17.6% in the control group), and overall screening and vaccination compliance rate (87% in the intervention group vs 3.8% in the control group). Participants in the intervention group were significantly more likely to receive HBV screening (92.5%) compared with those in the control group (5.5%). In multivariate mixed-effect logistic regression analysis, the odds ratio for an intervention effect on HBV screening was 512.3 after adjusting for cluster effect and other demographic variables. With regard to vaccination rates, of the 332 participants who were screened with no immunity in the intervention group, 308 (92.8%) received at least 1 HBV vaccination, 300 (90.4%) received at least 2 shots, and 279 participants (84%) received all 3 shots. CONCLUSIONS: A combination of community-based participatory research and a multilevel approach may produce the most optimal results and be essential in producing a considerable effect for enhancing HBV screening and vaccination, particularly for Korean American populations with limited language proficiency and insurance coverage. Cancer 2018;124:973-82. © 2017 American Cancer Society.

Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial.

BACKGROUND: Most health care providers do not treat tobacco dependence routinely. This may in part be due to the treatment "default." Current treatment guidelines recommend that providers (1) ask patients if they are willing to quit and (2) provide cessation-focused medications and counseling only to smokers who state that they are willing to quit. The default is that patients have to "opt in" to receive cessation assistance: providers ask smokers if they are willing to quit, and only offer medications and cessation support to those who say "yes." This drastically limits the reach of cessation services because, at any given encounter, only one in three smokers say that they are ready to quit. The objective of this study is to determine the impact of providing all smokers with tobacco-cessation treatment unless they refuse it (OPT OUT) versus current practice-screening for readiness and only offering treatment to smokers who say they are ready to quit (OPT IN). METHODS: This individually randomized clinical trial is conducted in a tertiary-care hospital. We will conduct the trial among up to 1000 randomly selected hospitalized smokers to determine the population impact of changing the treatment default, identify mediators of outcome, and determine the cost-effectiveness of this new, highly proactive approach. This is a population-based study that targets an endpoint of vital interest; applies minimal eligibility criteria to broaden generalizability; and utilizes hospital staff for interventions to ensure long-term sustainability. The study employs delayed consent and an innovative Bayesian adaptive design to evaluate a major shift in our approach to care. If effective, this change would expand the reach of tobacco-cessation treatment from 30% to 100% of smokers. DISCUSSION: Regardless of outcome, the trial will provide a model of how to alter and evaluate the impact of health care defaults. If OPT OUT proves to be more effective, it will expand the population eligible for cessation treatment by over 300%. It will also simplify the tobacco-cessation treatment algorithm, and relieve busy health care providers of the burden of evaluating readiness to quit. TRIAL REGISTRATION: Clinical Trials Registration, ID: NCT02721082 . Registered on 22 March 2016.

Medicaid Coverage of Smoking Cessation Counseling and Medication Is Underutilized for Pregnant Women.

INTRODUCTION: Policies to promote smoking cessation among Medicaid-insured pregnant women have the potential to assist a significant proportion of pregnant smokers. In 2010, Kansas Medicaid began covering smoking cessation counseling for pregnant smokers. Our aim was to evaluate the use of smoking cessation benefits provided to pregnant women as a result of the Kansas Medicaid policy change that provided reimbursement for physician-provided smoking cessation counseling. METHODS: We examined Kansas Medicaid claims data to estimate rates of delivery of smoking cessation treatment to Medicaid-insured pregnant women in Kansas from fiscal year 2010 through 2013. We analyzed the number of pregnant women who received physician-provided smoking cessation counseling indicated by procedure billing codes (ie, G0436 and G0437) and medication (ie, nicotine replacement therapy, bupropion, or varenicline) located in outpatient managed care encounter and fee-for-service claims data. We estimated the number of Medicaid-insured pregnant smokers using the national smoking prevalence (14%) in this population and the number of live births reported in Kansas. RESULTS: Annually from 2010 to 2013, approximately 27.2%-31.6% of pregnant smokers had claims for nicotine replacement therapy, bupropion, or varenicline. Excluding claims for bupropion, a medication commonly prescribed to treat depression, claims ranged from 9.3% to 11.1%. Following implementation of Medicaid coverage for smoking cessation counseling, less than 1% of estimated smokers had claims for counseling. CONCLUSIONS: This low claims rate suggests that simply changing policy is not sufficient to ensure use of newly implemented benefits, and that there probably remain critical gaps in smoking cessation treatment. IMPLICATIONS: This study evaluates the use of Medicaid reimbursement for smoking cessation counseling among low-income pregnant women in Kansas. We describe the Medicaid claims rates of physician-provided smoking cessation counseling for pregnant women, an evidence-based and universally recommended treatment approach for smoking cessation in this population. Our findings show that claims rates for smoking cessation benefits in this population are very low, even after policy changes to support provision of cessation assistance were implemented. Additional studies are needed to determine whether reimbursement is functioning as intended and identify potential gaps between policy and implementation of evidence-based smoking cessation treatment.

Pharmaceutical assistance programs to support smoking cessation medication access.

OBJECTIVES: Rural smokers are more likely to be uninsured and live in poverty, which may pose significant cost barriers to accessing smoking cessation medications. As part of a randomized clinical trial, we provided support to connect low-income smokers with the use of pharmaceutical assistance programs (PAPs) to improve medication access. METHODS: Study participants were rural smokers enrolled in a randomized clinical trial testing in-office telemedicine versus telephone-based approaches to deliver counseling sessions. For potentially qualified participants, we developed a system to connect them with PAPs that provided smoking cessation medications at low or no cost. Participants reported medication utilization 3 and 6 months after randomization. RESULTS: Of the 560 study participants, 312 (55.7%) met initial screening criteria for PAP eligibility. Of those eligible, 104 (33.3%) initiated a PAP application, with 49 (15.7%) completing the application and ultimately receiving medications through the programs. Despite the availability of assistance with the PAP application process, overall medication use among those that were eligible for PAP was significantly lower than among participants with higher incomes or access to prescription insurance (60.4% vs. 51.3%; P = 0.04). Abstinence among PAP-eligible smokers was also lower at the 3-month follow-up (P = 0.01), but this difference was not present at the 6- and 12-month follow-up surveys. CONCLUSION: With substantial assistance, some low-income smokers without prescription insurance can get effective smoking cessation medications through PAPs, but overall access remains worse than among those with higher incomes or prescription insurance.

Indoor tobacco legislation is associated with fewer emergency department visits for asthma exacerbation in children.

BACKGROUND: During the past 3 decades, numerous cities and states have adopted laws that ban smoking in public indoor spaces. The rationale for these policies has been to protect nonsmokers from the adverse health effects of secondhand smoke. OBJECTIVE: To determine whether the implementation of indoor smoking legislation is associated with a decrease in emergency department visits for asthma in children. METHODS: This retrospective analysis used a natural experiment to estimate the impact of clean indoor air legislation on the rate of emergency department admissions for asthma exacerbation in children. Data were obtained from the Pediatric Health Information System. A Poisson regression was used for analyses and controlled for age, sex, race, payer source, seasonality, and secular trends. RESULTS: Asthma emergency department visits were captured from 20 hospitals in 14 different states plus the District of Columbia from July 2000 to January 2014 (n = 335,588). Indoor smoking legislation, pooled across all cities, was associated with a decreased rate of severe asthma exacerbation (adjusted rate ratio 0.83, 95% confidence interval 0.82-0.85, P < .0001). CONCLUSION: Indoor tobacco legislation is associated with a decrease in emergency department visits for asthma exacerbation. Such legislation should be considered in localities that remain without this legislation to protect the respiratory health of their children.

Warm Handoff Versus Fax Referral for Linking Hospitalized Smokers to Quitlines.

INTRODUCTION: Few hospitals treat patients' tobacco dependence. To be effective, hospital-initiated cessation interventions must provide at least 1 month of supportive contact post-discharge. STUDY DESIGN: Individually randomized clinical trial. Recruitment commenced July 2011; analyses were conducted October 2014-June 2015. SETTING/PARTICIPANTS: The study was conducted in two large Midwestern hospitals. Participants included smokers who were aged ≥18 years, planned to stay quit after discharge, and spoke English or Spanish. INTERVENTION: Hospital-based cessation counselors delivered the intervention. For patients randomized to warm handoff, staff immediately called the quitline from the bedside and handed the phone to participants for enrollment and counseling. Participants randomized to fax were referred on the day of hospital discharge. MAIN OUTCOME MEASURES: Outcomes at 6 months included quitline enrollment/adherence, medication use, biochemically verified cessation, and cost effectiveness. RESULTS: Significantly more warm handoff than fax participants enrolled in quitline (99.6% vs 59.6%; relative risk, 1.67; 95% CI=1.65, 1.68). One in four (25.4% warm handoff, 25.3% fax) were verified to be abstinent at 6-month follow-up; this did not differ significantly between groups (relative risk, 1.02; 95% CI=0.82, 1.24). Cessation medication use in the hospital and receipt of a prescription for medication at discharge did not differ between groups; however, significantly more fax participants reported using cessation medication post-discharge (32% vs 25%, p=0.01). The average incremental cost-effectiveness ratio of enrolling participants into warm handoff was $0.14. Hospital-borne costs were significantly lower in warm handoff than in fax ($5.77 vs $9.41, p<0.001). CONCLUSIONS: One in four inpatient smokers referred to quitline by either method were abstinent at 6 months post-discharge. Among motivated smokers, fax referral and warm handoff are efficient and comparatively effective ways to link smokers with evidence-based care. For hospitals, warm handoff is a less expensive and more effective method for enrolling smokers in quitline services.

CHARTing a Path to Pragmatic Tobacco Treatment Research.

INTRODUCTION: It is important to consider the degree to which studies are explanatory versus pragmatic to understand the implications of their findings for patients, healthcare professionals, and policymakers. Pragmatic trials test the effectiveness of interventions in real-world conditions; explanatory trials test for efficacy under ideal conditions. The Consortium of Hospitals Advancing Research on Tobacco (CHART) is a network of seven NIH-funded trials designed to identify effective programs that can be widely implemented in routine clinical practice. METHODS: A cross-sectional analysis of CHART trial study designs was conducted to place each study on the pragmatic-explanatory continuum. After reliability training, six raters independently scored each CHART study according to ten PRagmatic Explanatory Continuum Indicator Summary (PRECIS) dimensions, which covered participant eligibility criteria, intervention flexibility, practitioner expertise, follow-up procedures, participant compliance, practitioner adherence, and outcome analyses. Means and SDs were calculated for each dimension of each study, with lower scores representing more pragmatic elements. Results were plotted on "spoke and wheel" diagrams. The rating process and analyses were performed in October 2014 to September 2015. RESULTS: All seven CHART trials tended toward the pragmatic end of the spectrum, although there was a range from 0.76 (SD=0.23) to 1.85 (SD=0.58). Most studies included some explanatory design elements. CONCLUSIONS: CHART findings should be relatively applicable to clinical practice. Funders and reviewers could integrate PRECIS criteria into their guidelines to better facilitate pragmatic research. CHART study protocols, coupled with scores reported here, may help readers improve the design of their own pragmatic trials.