A smoking cessation intervention for rural veterans tailored to individual risk factors: A multicenter randomized clinical trial.

INTRODUCTION: Rates of cigarette use remain elevated among those living in rural areas. Depressive symptoms, risky alcohol use, and weight concerns frequently accompany cigarette smoking and may adversely affect quitting. Whether treatment for tobacco use that simultaneously addresses these issues affects cessation outcomes is uncertain. METHODS: The study was a multicenter, two-group, randomized controlled trial involving mostly rural veterans who smoke (N = 358) receiving treatment at one of five Veterans Affairs Medical Centers. The study randomly assigned participants to a tailored telephone counseling intervention or referral to their state tobacco quitline. Both groups received guideline-recommended smoking cessation pharmacotherapy, selected using a shared decision-making approach. The primary outcome was self-reported seven-day point prevalence abstinence (PPA) at three and six months. The study used salivary cotinine to verify self-reported quitting at six months. RESULTS: Self-reported PPA was significantly greater in participants assigned to Tailored Counseling at three (OR = 1.66; 95 % CI: 1.07-2.58) but not six (OR = 1.35; 95 % CI: 0.85-2.15) months. Post hoc subgroup analyses examining treatment group differences based on whether participants had a positive screen for elevated depressive symptoms, risky alcohol use, and/or concerns about weight gain indicated that the cessation benefit of Tailored Counseling at three months was limited to those with ≥1 accompanying concern (OR = 2.02, 95 % CI: 1.20-3.42). Biochemical verification suggested low rates of misreporting. CONCLUSIONS: A tailored smoking cessation intervention addressing concomitant risk factors enhanced short-term abstinence but did not significantly improve long-term quitting. Extending the duration of treatment may be necessary to sustain treatment effects.

A Needs Assessment of Ohio Farmers' Self-Reported Health Behaviors.

The study purpose was a needs assessment, to identify and quantify health behavior risk-factors of Ohio farmers in sleep, mental health, fruit/vegetable serving frequency, physical activity, tobacco, alcohol and illicit drug use, and weight status. Guided by the RE-AIM implementation framework, the research question was What behavioral choices pose health risk factors for Ohio farmers? This cross-sectional, quantitative, descriptive study used Qualtrics' hyperlinks, QR codes, or paper-and-pencil surveys to collect data on seven focused health behaviors. The survey combined valid and reliable public domain questionnaires. The target audience included Ohio farmers representing various commodities. Extension educators at the county, regional, and state level provided access and data collection during their existing community-based programs and annual pesticide training sessions. The survey has been opened from January 20, 2020 to December 5, 2020 with modified recruitment during COVID. A convenience sample of 505 farmers participated. The majority self-identified as male, married, white, non-Latino, and worked full-time. The most frequent commodity was field crops. Most farmers reported 7-to-8 h of sleep, but the MOS SLP6 subscale indicated 89.5% of the farmers reported a score greater than 51. The two PHQ-2 questions showed 9.6% of the farmers scored >3, indicating a likely major depression disorder. Fruit and vegetable serving frequency appeared less than dietary recommendations. Time spent in physical activity did not meet guidelines. Almost 80% of the farmers said they did not use tobacco; the most common choice was chews and snuffs. Audit-C showed 31.4% of the men and 27.7% of the women can be categorized as hazardous drinkers. Illicit drug use was reported by 3.7%. Most farmers were obese or overweight. Male respondents were 83.5% overweight or obese; females 70.8% were overweight or obese. Males ages 55-64 years were mostly likely to be obese (58%) followed by males ages 35-44 years (46%). Results were compared to Ohio's Behavioral Risk Factor Surveillance System. These data will assist county Extension educators in identifying health prevention programming important for farm populations, utilizing community resources and services. While the findings of Ohio farmers may not be generalizable to other state farming communities, this survey and lessons learned can serve as a model for other Extension assessments.

Health Behavior Resources Available to Farmers in Rural Ohio.

Poor health habits correlate with morbidity and mortality. Rural communities often have decreased access to prevention programs and health care. As a state highly dependent on agriculture, this study identifies rural health services for Ohio farmers. This cross-sectional, descriptive study surveys key informants in Ohio at rural health clinics, critical access hospitals, health departments, Ohio State University (OSU) Extension offices, migrant clinics, and Federally Qualified Health Centers about the types of services available to address eight health behaviors. Key informants were invited via email and U.S. Postal Service to complete an electronic survey. After service types were identified, additional information to describe format, barriers to delivery and perceived importance of the service was asked. Of Ohio's 75 rural counties, 51 counties are represented in the data by at least one participating organization. Nutrition/healthy eating-related health services are provided most often by organizations (95.8%) and sleep services were least often reported (49.5%). The other health behaviors services (sun/UV exposure, physical activity, mental health, tobacco cessation, alcohol/substance abuse, and opioid abuse) fell in-between. Organizations are most likely to offer health education resources in print or web-based format across all health behaviors except for sleep, where social media promotion are the most common. The largest barrier to providing any type of health service is a lack of personnel. Providing health behavior services to farmers and farm families is important for improving their overall health. Documenting available services will assist the rural health community in future collaborative wellness projects.

Provider and clinical setting characteristics associated with tobacco pharmacotherapy dispensed in the Veterans Health Administration.

INTRODUCTION: While initiation rates of tobacco cessation pharmacotherapy have improved both inside and outside the Department of Veteran Affairs (VA), prescribing rates remain low. The objective of this study was to examine correlation of the characteristics of providers, clinics, and facilities with initiation of tobacco cessation pharmacotherapy. METHODS: This retrospective, observational study used VA outpatient electronic medical record data from federal fiscal year 2011. Logistic regression models estimated the adjusted odds ratio associated with provider characteristics for pharmacotherapy initiation. RESULTS: For the 639507 veterans who used tobacco, there were 30388 providers caring for them. Younger (p<0.001) and female (p<0.001) providers were more likely to initiate tobacco cessation pharmacotherapy. Compared to physicians, pharmacists were 74% more likely to initiate pharmacotherapy, while all groups of nurses were 5-8% and physicians' assistants were 12% less likely (p<0.001). Compared to those seen in primary care clinics, patients assessed in substance use treatment clinics were 16% more likely to have pharmacotherapy initiated (p<0.001), while those in psychiatry were 10% less likely (p<0.001), and those in outpatient surgery were 39% less likely to initiate pharmacotherapy (p<0.001). Compared to almost all other classes of VA facilities, patients seen in primary care community-based outpatient clinics (CBOCs) were 7-28% more likely to initiate pharmacotherapy (p<0.0001). CONCLUSIONS: While the VA is at the leading edge of providing tobacco cessation pharmacotherapy, targeting quality improvement efforts towards providers, clinics, and facilities with low prescribing rates will be essential to continue the declining rates of tobacco use among VA patients.

Genetic Testing and Surveillance of Young Breast Cancer Survivors and Blood Relatives: A Cluster Randomized Trial.

We compared a tailored and a targeted intervention designed to increase genetic testing, clinical breast exam (CBE), and mammography in young breast cancer survivors (YBCS) (diagnosed <45 years old) and their blood relatives. A two-arm cluster randomized trial recruited a random sample of YBCS from the Michigan cancer registry and up to two of their blood relatives. Participants were stratified according to race and randomly assigned as family units to the tailored (n = 637) or the targeted (n = 595) intervention. Approximately 40% of participants were Black. Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services (p = 0.0205) at 8-months follow-up. Genetic testing increased approximately 5% for YBCS in the tailored and the targeted arm (p ≤ 0.001; p < 0.001) and for Black and White/Other YBCS (p < 0.001; p < 0.001). CBEs and mammograms increased significantly in both arms, 5% for YBCS and 10% for relatives and were similar for Blacks and White/Others. YBCS and relatives needing less support from providers reported significantly higher self-efficacy and intention for genetic testing and surveillance. Black participants reported significantly higher satisfaction and acceptability. Effects of these two low-resource interventions were comparable to previous studies. Materials are suitable for Black women at risk for hereditary breast/ovarian cancer (HBOC).

Cost-effectiveness of a nurse-delivered, inpatient smoking cessation intervention.

Randomized controlled trials have shown that inpatient tobacco cessation interventions are highly efficacious and cost-effective. However, the degree to which smoking interventions implemented in nonrandomized, real-world practice settings are effective, and consequently, cost-effective, remains unclear. This study evaluated the cost-effectiveness of a nurse-delivered, inpatient smoking cessation intervention, Tobacco Tactics, compared with usual care within the context of an observational, real-world study design. In this quasi-experimental study, five Michigan hospitals (N = 1,370 patients) were assigned to implement either Tobacco Tactics or usual care during October 2011-May 2013. Statistical analysis was conducted during January 2017-February 2018. Controlling for confounding using stabilized inverse probability of treatment weights, incremental cost-effectiveness ratios were calculated and cost-effectiveness acceptability curves were generated. The per person cost of tobacco cessation services in the intervention group exceeded that of usual care ($175.52 vs. $67.80; p < .001). The intervention group had a higher propensity-adjusted self-reported quit rate compared to the control group (15.7% vs. 7.0%; p < .0001). The propensity-adjusted incremental cost-effectiveness ratio was $1,325 per quit (95% confidence interval: $751-$2,462), with 99.9% probability of being cost-effective at a willingness to pay of $5,000 per quit. The Tobacco Tactics intervention was found to be cost-effective and well within the range of incremental cost-per-quit findings from other studies of tobacco cessation interventions, which range from $918 to $23,200, adjusted for inflation.

Cost-effectiveness of real-world administration of tobacco pharmacotherapy in the United States Veterans Health Administration.

BACKGROUND AND AIMS: Cost-effectiveness studies in randomized clinical trials have shown that tobacco cessation pharmacotherapy is among the most cost-effective of health-care interventions. Clinical trial eligibility criteria and treatment protocols may not be followed in actual practice. This study aimed to determine whether tobacco cessation pharmacotherapy is cost-effective in real-world settings. DESIGN: A retrospective analysis of costs and outcomes. SETTING: Hospitals and clinics of the US Veterans Health Administration, USA. PARTICIPANTS: A total of 589 862 US veterans who screened positive for tobacco use in 2011. INTERVENTION AND COMPARATOR: Tobacco users who initiated smoking cessation pharmacotherapy in the 6 months after screening were compared with those who did not use pharmacotherapy in this period. Pharmacotherapy included nicotine replacement therapy, bupropion (if prescribed at 300 mg per day or specifically for tobacco cessation) or varenicline. MEASURES: Effectiveness was determined from responses to a subsequent tobacco screening conducted between 7 and 18 months after the treatment observation period. Cost of medications and prescribing health-care encounters was determined for the period between initial and follow-up tobacco use screening. Multivariate fixed-effects regression was used to assess the effect of initial treatment status on cost and outcome while controlling for differences in case-mix with propensity weighting to adjust for confounding by indication. FINDINGS: Thirteen per cent of participants received tobacco cessation pharmacotherapy within 6 months of initial screening. After an average of an additional 218.1 days' follow-up, those who initially received pharmacotherapy incurred $143.79 in additional treatment cost and had a 3.1% absolute increase in tobacco quit rates compared with those who were not initially treated. This represents an incremental cost-effectiveness ratio of $4705 per quit. The upper limit of the 99.9% confidence region was $5600 per quit. Without propensity adjustment, the cost-effectiveness ratio was $7144 per quit, with the upper limit of the 99.9% confidence region $9500/quit. CONCLUSIONS: Tobacco cessation pharmacotherapy provided by the US Veterans Health Administration in 2011/12 was cost-effective in this real-world setting, with an incremental cost-effectiveness ratio of $4705 per quit.

Effectiveness of tobacco cessation pharmacotherapy in the Veterans Health Administration.

INTRODUCTION: In 2003, the Veterans Health Administration (VHA) implemented a directive that cessation pharmacotherapy be made available to all who use tobacco and are interested in quitting. Despite the efficacy of cessation pharmacotherapy shown in clinical trials, the generalisability of the results in real-world settings has been challenged. Hence, the specific aim of this study was to determine the effectiveness of cessation pharmacotherapies in the VHA. METHODS: This retrospective cohort study used VHA's electronic medical record data to compare quit rates among those who use tobacco and who did vs. did not receive any type of cessation pharmacotherapy. Included were 589 862 Veterans identified as current tobacco users during fiscal year 2011 who had not received cessation pharmacotherapy in the prior 12 months. Following a 6-month period to assess treatment, quit rates among those who were treated versus untreated were compared during the 7-18 months (12 months) post-treatment follow-up period. The estimated treatment effect was calculated from a logistic regression model adjusting for inverse probability of treatment weights (IPTWs) and covariates. Marginal probabilities of quitting were also obtained among those treated versus untreated. RESULTS: Adjusting for IPTWs and covariates, the odds of quitting were 24% higher among those treated versus untreated (OR=1.24, 95% CI 1.23 to 1.25, p<0.001). The marginal probabilities of quitting were 16.7% for the untreated versus 19.8% for the treated based on the weighted model. CONCLUSION: The increased quit rates among Veterans treated support the effectiveness and continuation of the VHA tobacco cessation pharmacotherapy policy.

Disparities in genetic services utilization in a random sample of young breast cancer survivors.

PURPOSE: Increasing use of genetic services (counseling/testing) among young breast cancer survivors (YBCS) can help decrease breast cancer incidence and mortality. The study examined use of genetic services between Black and White/Other YBCS, attitudes and knowledge of breast cancer risk factors, and reasons for disparities in using genetic services. METHODS: We used baseline data from a randomized control trial including a population-based, stratified random sample of 3000 potentially eligible YBCS, with oversampling of Black YBCS. RESULTS: Among 883 YBCS (353 Black, 530 White/Other) were significant disparities between the two racial groups. More White/Other YBCS had received genetic counseling and had genetic testing than Blacks. Although White/Other YBCS resided farther away from board-certified genetic counseling centers, they had fewer barriers to access these services. Black race, high out-of-pocket costs, older age, and more years since diagnosis were negatively associated with use of genetic services. Black YBCS had lower knowledge of breast cancer risk factors. Higher education and genetic counseling were associated with higher genetic knowledge. CONCLUSION: Racial inequalities of cost-related access to care and education create disparities in genetic services utilization. System-based interventions that reduce socioeconomic disparities and empower YBCS with genetic knowledge, as well as physician referrals, can increase access to genetic services.

Trends and Patient Characteristics Associated with Tobacco Pharmacotherapy Dispensed in the Veterans Health Administration.

Introduction: There is evidence suggesting that certain subgroups of people who use tobacco do not receive tobacco pharmacology as consistently as others. Methods: This retrospective, cohort study examined the trend in the use of cessation pharmacotherapy from 2004 to 2013 using Veterans Health Administration (VHA) administrative data. Among Veterans who used tobacco in the fiscal year (FY) 2011 and had not received pharmacotherapy in the prior year, multivariable Cox regression was used to assess the independent associations between patient clinical and demographic characteristics and pharmacotherapy initiation in the 6-months follow-up period. Results: Smoking cessation pharmacotherapy in the VHA increased from 13.8% in 2004 to 25.6% in 2013. In 2011, Veterans (N = 838309) who were more likely to newly receive pharmacotherapy included those with psychiatric disorders (depression, bipolar disorder, non-alcohol substance use disorder, other anxiety, and post-traumatic stress disorder), chronic pulmonary disease, peripheral vascular disorders, and younger Veterans (adjusted rate ratios (ARRs) ranged from 1.03 to 1.92, all p < .001). Veterans less likely to receive pharmacotherapy were those with schizophrenia or other psychosis, males, Hispanics, and those with a medical condition (uncomplicated diabetes, uncomplicated hypertension, fluid and electrolyte disorders, cardiac arrhythmia, valvular disease, hypothyroidism, acquired immunodeficiency syndrome/human immunodeficiency virus, deficiency anemia, renal failure, paralysis, coagulopathy, metastatic cancer, and other neurological disorders) (ARRs ranged from 0.74 to 0.93, all p < .001). Conclusions: Although VHA cessation pharmacotherapy use nearly doubled from 13.8% in 2004 to 25.6% in 2013, reaching undertreated subgroups, especially those with medical comorbidities, may improve cessation outcomes. Implications: Despite evidence that demographics influence the use of pharmacotherapy in smoking cessation, there is limited and contradictory information regarding how psychiatric and chronic medical illnesses affect pharmacotherapy use. Administrative data were used to determine trends and patient characteristics of those receiving pharmacotherapy to aid in smoking cessation in the Veterans Health Administration. From 2004 to 2013, pharmacotherapy use increased from 13.8% to 25.6% of current smokers. Factors associated with increased pharmacotherapy initiation were psychiatric disorders, chronic pulmonary disease, peripheral vascular disorders, and younger age. Veterans with schizophrenia or other psychosis, males, Hispanics, and most medical conditions were less likely to receive pharmacotherapy.

The Sun Solutions Intervention for Operating Engineers: A Randomized Controlled Trial.

Background: Because Operating Engineers (heavy equipment operators) are outdoor workers at risk for skin cancer, interventions are needed to promote sun safety. The objectives were to determine changes in sunscreen use and sunburning among Operating Engineers randomized to four conditions in the Sun Solutions study: (i) education only; (ii) education and text message reminders; (ii) education and mailed sunscreen; and (iv) education, text message reminders, and mailed sunscreen.Methods: In this randomized controlled trial, Operating Engineers (N = 357) were recruited at required safety training sessions throughout Michigan during winter/spring of 2012 to 2013 and provided baseline surveys. The four interventions were delivered over the summer. Postintervention surveys were collected in the fall (82.1% follow-up).Results: Sunscreen use improved significantly from baseline to follow-up in all four conditions (P < 0.05), except sunscreen use among those receiving education and text message reminders was only marginally significant (P = 0.07). There were significantly greater increases in sunscreen use in the two conditions that were mailed sunscreen (P < 0.001). There was a significant decrease in the number of reported sunburns from baseline to follow-up in all four conditions (P < 0.001), but there were no significant differences in sunburns among the groups. Participant evaluated the interventions highly with those who received mailed sunscreen rating the intervention the highest.Conclusions: Providing proper sun-safety education and minimizing barriers to sunscreen use can increase sunscreen use and decrease reported sunburns.Impact: The implementation of the Sun Solutions intervention may be an effective method to modify skin cancer-related behaviors. Cancer Epidemiol Biomarkers Prev; 27(8); 864-73. ©2018 AACR.

Surveillance for cancer recurrence in long-term young breast cancer survivors randomly selected from a statewide cancer registry.

PURPOSE: This study examined clinical breast exam (CBE) and mammography surveillance in long-term young breast cancer survivors (YBCS) and identified barriers and facilitators to cancer surveillance practices. METHODS: Data collected with a self-administered survey from a statewide, randomly selected sample of YBCS diagnosed with invasive breast cancer or ductal carcinoma in situ younger than 45 years old, stratified by race (Black vs. White/Other). Multivariate logistic regression models identified predictors of annual CBEs and mammograms. RESULTS: Among 859 YBCS (n = 340 Black; n = 519 White/Other; mean age = 51.0 ± 5.9; diagnosed 11.0 ± 4.0 years ago), the majority (> 85%) reported an annual CBE and a mammogram. Black YBCS in the study were more likely to report lower rates of annual mammography and more barriers accessing care compared to White/Other YBCS. Having a routine source of care, confidence to use healthcare services, perceived expectations from family members and healthcare providers to engage in cancer surveillance, and motivation to comply with these expectations were significant predictors of having annual CBEs and annual mammograms. Cost-related lack of access to care was a significant barrier to annual mammograms. CONCLUSIONS: Routine source of post-treatment care facilitated breast cancer surveillance above national average rates. Persistent disparities regarding access to mammography surveillance were identified for Black YBCS, primarily due to lack of access to routine source of care and high out-of-pocket costs. IMPLICATIONS: Public health action targeting cancer surveillance in YBCS should ensure routine source of post-treatment care and address cost-related barriers. Clinical Trials Registration Number: NCT01612338.

Changes in Veteran Tobacco Use Identified in Electronic Medical Records.

INTRODUCTION: Electronic medical records represent a new source of longitudinal data on tobacco use. METHODS: Electronic medical records of the U.S. Department of Veterans Affairs were extracted to find patients' tobacco use status in 2009 and at another assessment 12-24 months later. Records from the year prior to the first assessment were used to determine patient demographics and comorbidities. These data were analyzed in 2015. RESULTS: An annual quit rate of 12.0% was observed in 754,504 current tobacco users. Adjusted tobacco use prevalence at follow-up was 3.2% greater with alcohol use disorders at baseline, 1.9% greater with drug use disorders, 3.3% greater with schizophrenia, and lower in patients with cancer, heart disease, and other medical conditions (all differences statistically significant with p<0.05). Annual relapse rates in 412,979 former tobacco users were 29.6% in those who had quit for <1 year, 9.7% in those who had quit for 1-7 years, and 1.9% of those who had quit for >7 years. Among those who had quit for <1 year, adjusted relapse rates were 4.3% greater with alcohol use disorders and 7.2% greater with drug use disorders (statistically significant with p<0.05). CONCLUSIONS: High annual cessation rates may reflect the older age and greater comorbidities of the cohort or the intensive cessation efforts of the U.S. Department of Veterans Affairs. The lower cessation and higher relapse rates in psychiatric and substance use disorders suggest that these groups will need intensive and sustained cessation efforts.

Recruiting families at risk for hereditary breast and ovarian cancer from a statewide cancer registry: a methodological study.

PURPOSE: Cancer genetic services (counseling/testing) are recommended for women diagnosed with breast cancer younger than 45 years old (young breast cancer survivors-YBCS) and at-risk relatives. We present recruitment of YBCS, identification and recruitment of at-risk relatives, and YBCS willingness to contact their cancer-free, female relatives. METHODS: A random sample of 3,000 YBCS, stratified by race (Black vs. White/Other), was identified through a population-based cancer registry and recruited in a randomized trial designed to increase use of cancer genetic services. Baseline demographic, clinical, and family characteristics, and variables associated with the Theory of Planned Behavior (TPB) were assessed as predictors of YBCS' willingness to contact at-risk relatives. RESULTS: The 883 YBCS (33.2% response rate; 40% Black) who returned a survey had 1,875 at-risk relatives and were willing to contact 1,360 (72.5%). From 853 invited at-risk relatives (up to two relatives per YBCS), 442 responded (51.6% response rate). YBCS with larger families, with a previous diagnosis of depression, and motivated to comply with recommendations from family members were likely to contact a greater number of relatives. Black YBCS were more likely to contact younger relatives and those living further than 50 miles compared to White/Other YBCS. CONCLUSION: It is feasible to recruit diverse families at risk for hereditary cancer from a population-based cancer registry. This recruitment approach can be used as a paradigm for harmonizing processes and increasing internal and external validity of large-scale public health genomic initiatives in the era of precision medicine.

Implementation of the Tobacco Tactics intervention versus usual care in Trinity Health community hospitals.

BACKGROUND: Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation framework, a National Institutes of Health-sponsored study compared the nurse-administered Tobacco Tactics intervention to usual care. A prior paper describes the effectiveness of the Tobacco Tactics intervention. This subsequent paper provides data describing the remaining constructs of the RE-AIM framework. METHODS: This pragmatic study used a mixed methods, quasi-experimental design in five Michigan community hospitals of which three received the nurse-administered Tobacco Tactics intervention and two received usual care. Nurses and patients were surveyed pre- and post-intervention. Measures included reach (patient participation rates, characteristics, and receipt of services), adoption (nurse participation rates and characteristics), implementation (pre-to post-training changes in nurses' attitudes, delivery of services, barriers to implementation, opinions about training, documentation of services, and numbers of volunteer follow-up phone calls), and maintenance (continuation of the intervention once the study ended). RESULTS: Reach: Patient participation rates were 71.5 %. Compared to no change in the control sites, there were significant pre- to post-intervention increases in self-reported receipt of print materials in the intervention hospitals (n = 1370, p < 0.001). Adoption: In the intervention hospitals, all targeted units and several non-targeted units participated; 76.0 % (n = 1028) of targeted nurses and 317 additional staff participated in the training, and 92.4 % were extremely or somewhat satisfied with the training. IMPLEMENTATION: Nurses in the intervention hospitals reported increases in providing advice to quit, counseling, medications, handouts, and DVD (all p < 0.05) and reported decreased barriers to implementing smoking cessation services (p < 0.001). Qualitative comments were very positive ("user friendly," "streamlined," or "saves time"), although problems with showing patients the DVD and charting in the electronic medical record were noted. Maintenance: Nurses continued to provide the intervention after the study ended. CONCLUSIONS: Given that nurses represent the largest group of front-line providers, this intervention, which meets Joint Commission guidelines for treating inpatient smokers, has the potential to have a wide reach and to decrease smoking, morbidity, and mortality among inpatient smokers. As we move toward more population-based interventions, the RE-AIM framework is a valuable guide for implementation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01309217.

Effectiveness of the Tobacco Tactics Program in the Trinity Health System.

INTRODUCTION: This study determined the effectiveness of the Tobacco Tactics intervention. DESIGN/SETTING/PARTICIPANTS: This was a pragmatic, quasi-experimental study conducted from 2010 to 2013 and analyzed from 2014 to 2015 in five Michigan community hospitals; three received the Tobacco Tactics intervention, and two received usual care. Smokers (N=1,528) were identified during hospitalization, and sent surveys and cotinine tests after 6 months. Changes in pre- to post-intervention quit rates in the intervention sites were compared with usual care control sites. INTERVENTION: The toolkit for nurses included: (1) 1 continuing education unit contact hour for training; (2) a PowerPoint presentation on behavioral and pharmaceutical interventions; (3) a pocket card entitled "Helping Smokers Quit: A Guide for Clinicians"; (4) behavioral and pharmaceutical protocols; and (5) a computerized template for documentation. The toolkit for patients included: (1) a brochure; (2) a cessation DVD; (3) the Tobacco Tactics manual; (4) a 1-800-QUIT-NOW card; (5) nurse behavioral counseling and pharmaceuticals; (6) physician reminders to offer brief advice to quit coupled with medication sign-off; and (7) follow-up phone calls by trained hospital volunteers. MAIN OUTCOME MEASURES: The effectiveness of the intervention was measured by 6-month 30-day point prevalence; self-reported quit rates with NicAlert(®) urinary biochemical verification (48-hour detection period); and the use of electronic medical record data among non-responders. RESULTS: There were significant improvements in pre- to post-intervention self-reported quit rates (5.7% vs 16.5%, p<0.001) and cotinine-verified quit rates (4.3% vs 8.0%, p<0.05) in the intervention sites compared with no change in the control sites. Propensity-adjusted multivariable analyses showed a significant improvement in self-reported 6-month quit rates from the pre- to post-intervention time periods in the intervention sites compared to the control sites (p=0.044) and a non-statistically significant improvement in the cotinine-verified 6-month quit rate. CONCLUSIONS: The Tobacco Tactics intervention, which meets the Joint Commission standards for inpatient smoking, has the potential to significantly decrease smoking among inpatient smokers. TRIAL REGISTRATION: This study is registered at www.clinicaltrial.gov NCT01309217.

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.

Does Quitting Smoking Make a Difference Among Newly Diagnosed Head and Neck Cancer Patients?

INTRODUCTION: To determine if smoking after a cancer diagnosis makes a difference in mortality among newly diagnosed head and neck cancer patients. METHODS: Longitudinal data were collected from newly diagnosed head and neck cancer patients with a median follow-up time of 1627 days (N = 590). Mortality was censored at 8 years or September 1, 2011, whichever came first. Based on smoking status, all patients were categorized into four groups: continuing smokers, quitters, former smokers, or never-smokers. A broad range of covariates were included in the analyses. Kaplan-Meier curves, bivariate and multivariate Cox proportional hazards models were constructed. RESULTS: Eight-year overall mortality and cancer-specific mortality were 40.5% (239/590) and 25.4% (150/590), respectively. Smoking status after a cancer diagnosis predicted overall mortality and cancer-specific mortality. Compared to never-smokers, continuing smokers had the highest hazard ratio (HR) of dying from all causes (HR = 2.71, 95% confidence interval [CI] = 1.48-4.98). Those who smoked at diagnosis, but quit and did not relapse-quitters-had an improved hazard ratio of dying (HR = 2.38, 95% CI = 1.29-4.36) and former smokers at diagnosis with no relapse after diagnosis-former smokers-had the lowest hazard ratio of dying from all causes (HR = 1.68, 95% CI = 1.12-2.56). Similarly, quitters had a slightly higher hazard ratio of dying from cancer-specific reasons (HR = 2.38, 95% CI = 1.13-5.01) than never-smokers, which was similar to current smokers (HR = 2.07, 95% CI = 0.96-4.47), followed by former smokers (HR = 1.70, 95% CI = 1.00-2.89). CONCLUSIONS: Compared to never-smokers, continuing smokers have the highest HR of overall mortality followed by quitters and former smokers, which indicates that smoking cessation, even after a cancer diagnosis, may improve overall mortality among newly diagnosed head and neck cancer patients. Health care providers should consider incorporating smoking cessation interventions into standard cancer treatment to improve survival among this population. IMPLICATIONS: Using prospective observational longitudinal data from 590 head and neck cancer patients, this study showed that continuing smokers have the highest overall mortality relative to never-smokers, which indicates that smoking cessation, even after a cancer diagnosis, may have beneficial effects on long-term overall mortality. Health care providers should consider incorporating smoking cessation interventions into standard cancer treatment to improve survival among this population.

The Effect of Re-randomization in a Smoking Cessation Trial.

OBJECTIVES: The purpose of this sub-study was to determine whether operating engineers (heavy equipment operators) who failed to quit smoking in a randomized controlled trial would benefit from re-exposure to the interventions one year later. METHODS: Operating Engineers attending workplace safety training groups during the winters of 2010 to 2012 were randomized by training group to either to the Tobacco Tactics Web-based intervention or the 1-800-QUIT-NOW telephone line. Of the 145 original participants, 41 reappeared in training groups one year later and were re-randomized with their group. Seven-day point prevalence quit rates at 30-days and 6-months post-intervention were analyzed using the chi-square test and Fisher's exact test. RESULTS: At 30-day follow-up, an additional 9.8% (4/41) of repeaters had quit smoking. At 6-month follow-up, 12.2% (5/41) of repeaters had quit smoking. At 30-day follow-up, increased quitting was more common among those re-randomized to the intervention group than among those who received the control treatment, although this was not statistically significant and was no longer true at 6-month follow-up. CONCLUSIONS: Because many smokers make multiple attempts to quit smoking, re-enrollment of participants in smoking cessation trials may produce additional quitters.

Qualitative Analysis of the Experience of Mental Fatigue of Family Caregivers of Patients With Cancer in Phase I Trials.

PURPOSE/OBJECTIVES: To examine family caregivers' experience of mental fatigue, identify strategies they use to manage it, and ascertain the kind of help they would like from healthcare professionals.
. RESEARCH APPROACH: Descriptive, qualitative study that was part of a larger mixed-methods study.
. SETTING: Metropolitan comprehensive cancer center in the midwestern United States.
. PARTICIPANTS: 79 family caregivers of patients with advanced cancer who were participating in phase I clinical trials.
. METHODOLOGIC APPROACH: Caregivers completed a semistructured, open-ended questionnaire and demographic and health history forms.
. FINDINGS: Caregivers were able to define mental fatigue and give many examples of it. They reported that mental fatigue did not interfere with patient care, but that it did have a negative effect on their own self-care. They identified strategies to manage mental fatigue. They wanted more information and support from professionals.
. CONCLUSIONS: The majority of caregivers experienced mental fatigue, which manifested as trouble concentrating, difficulty remembering things, and irritability. The majority worked outside of the home and had health problems of their own.
. INTERPRETATION: Healthcare professionals need to assess caregivers for mental fatigue and find ways to help them reduce mental fatigue and restore their attention. Nurses are in a prime position to mobilize resources for caregivers to effectively manage burden and reduce mental fatigue.