Emotional Distress Predicts Reduced Type 2 Diabetes Treatment Adherence in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

OBJECTIVE: We examined longitudinal associations between emotional distress (specifically, depressive symptoms and diabetes distress) and medication adherence in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing four glucose-lowering medications added to metformin in adults with relatively recent-onset type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The Emotional Distress Substudy assessed medication adherence, depressive symptoms, and diabetes distress in 1,739 GRADE participants via self-completed questionnaires administered biannually up to 3 years. We examined baseline depressive symptoms and diabetes distress as predictors of medication adherence over 36 months. Bidirectional visit-to-visit relationships were also examined. Treatment satisfaction, beliefs about medication, diabetes care self-efficacy, and perceived control over diabetes were evaluated as mediators of longitudinal associations. RESULTS: At baseline, mean ± SD age of participants (56% of whom were White, 17% Hispanic/Latino, 18% Black, and 66% male) was 58.0 ± 10.2 years, diabetes duration 4.2 ± 2.8 years, HbA1c 7.5% ± 0.5%, and medication adherence 89.9% ± 11.1%. Higher baseline depressive symptoms and diabetes distress were independently associated with lower adherence over 36 months (P < 0.001). Higher depressive symptoms and diabetes distress at one visit predicted lower adherence at the subsequent 6-month visit (P < 0.0001) but not vice versa. Treatment assignment did not moderate relationships. Patient-reported concerns about diabetes medications mediated the largest percentage (11.9%-15.5%) of the longitudinal link between emotional distress and adherence. CONCLUSIONS: Depressive symptoms and diabetes distress both predict lower adherence to glucose-lowering medications over time among adults with T2DM. Addressing emotional distress and concerns about anticipated negative effects of taking these treatments may be important to support diabetes treatment adherence.

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.

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.

Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART).

BACKGROUND: This paper describes fidelity monitoring (treatment differentiation, training, delivery, receipt and enactment) across the seven National Institutes of Health-supported Consortium of Hospitals Advancing Research on Tobacco (CHART) studies. The objectives of the study were to describe approaches to monitoring fidelity including treatment differentiation (lack of crossover), provider training, provider delivery of treatment, patient receipt of treatment, and patient enactment (behavior) and provide examples of application of these principles. METHODS: Conducted between 2010 and 2014 and collectively enrolling over 9500 inpatient cigarette smokers, the CHART studies tested different smoking cessation interventions (counseling, medications, and follow-up calls) shown to be efficacious in Cochrane Collaborative Reviews. The CHART studies compared their unique treatment arm(s) to usual care, used common core measures at baseline and 6-month follow-up, but varied in their approaches to monitoring the fidelity with which the interventions were implemented. RESULTS: Treatment differentiation strategies included the use of a quasi-experimental design and monitoring of both the intervention and control group. Almost all of the studies had extensive training for personnel and used a checklist to monitor the intervention components, but the items on these checklists varied widely and were based on unique aspects of the interventions, US Public Health Service and Joint Commission smoking cessation standards, or counselor rapport. Delivery of medications ranged from 31 to 100 % across the studies, with higher levels from studies that gave away free medications and lower levels from studies that sought to obtain prescriptions for the patient in real world systems. Treatment delivery was highest among those studies that used automated (interactive voice response and website) systems, but this did not automatically translate into treatment receipt and enactment. Some studies measured treatment enactment in two ways (e.g., counselor or automated system report versus patient report) showing concurrence or discordance between the two measures. CONCLUSION: While fidelity monitoring can be challenging especially in dissemination trials, the seven CHART studies used a variety of methods to enhance fidelity with consideration for feasibility and sustainability. TRIAL REGISTRATION: Dissemination of Tobacco Tactics for hospitalized smokers. Clinical Trials Registration No. NCT01309217.Smoking cessation in hospitalized smokers. Clinical Trials Registration No. NCT01289275.Using "warm handoffs" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial. Clinical Trials Registration No. NCT01305928.Web-based smoking cessation intervention that transitions from inpatient to outpatient. Clinical Trials Registration No. NCT01277250.Effectiveness of smoking-cessation interventions for urban hospital patients. Clinical Trials Registration No. NCT01363245.Comparative effectiveness of post-discharge interventions for hospitalized smokers. Clinical Trials Registration No. NCT01177176.Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals. Clinical Trials Registration No. NCT01236079.

Effectiveness of the tobacco tactics program for psychiatric inpatient veterans: an implementation study.

BACKGROUND: The objective of this study was to evaluate the effectiveness of the inpatient, nurse-administered Tobacco Tactics program for patients admitted for psychiatric conditions in two Veterans Affairs (VA) hospitals compared to a control hospital. METHODS: This is a subgroup analysis of data from the inpatient tobacco tactics effectiveness trial, which was a longitudinal, pre- post-nonrandomized comparison design with 6-month follow-up in the three large Veterans Integrated Service Networks (VISN) 11 hospitals. RESULTS: Six-month self-reported quit rates for patients admitted for psychiatric conditions increased from 3.5% pre-intervention to 10.2% post-intervention compared to a decrease in self-reported quit rates in the control hospital (12% pre-intervention to 1.6% post-intervention). There was significant improvement in self-reported quit rates for the pre- versus post-intervention time periods in the Detroit and Ann Arbor intervention sites compared to the Indianapolis control site (P=0.01) and cotinine results were in the same direction. CONCLUSION: The implementation of the Tobacco Tactics intervention has the potential to significantly decrease smoking and smoking-related morbidity and mortality among smokers admitted to VA hospitals for psychiatric disorders.

Web-enhanced tobacco tactics with telephone support versus 1-800-QUIT-NOW telephone line intervention for operating engineers: randomized controlled trial.

BACKGROUND: Novel interventions tailored to blue collar workers are needed to reduce the disparities in smoking rates among occupational groups. OBJECTIVE: The main objective of this study was to evaluate the efficacy and usage of the Web-enhanced "Tobacco Tactics" intervention targeting operating engineers (heavy equipment operators) compared to the "1-800-QUIT-NOW" telephone line. METHODS: Operating engineers (N=145) attending one of 25 safety training sessions from 2010 through 2012 were randomized to either the Tobacco Tactics website with nurse counseling by phone and access to nicotine replacement therapy (NRT) or to the 1-800-QUIT-NOW telephone line, which provided an equal number of phone calls and NRT. The primary outcome was self-reported 7-day abstinence at 30-day and 6-month follow-up. The outcomes were compared using chi-square tests, t tests, generalized mixed models, and logistic regression models. RESULTS: The average age was 42 years and most were male (115/145, 79.3%) and white (125/145, 86.2%). Using an intent-to-treat analysis, the Tobacco Tactics website group showed significantly higher quit rates (18/67, 27%) than the 1-800-QUIT NOW group (6/78, 8%) at 30-day follow-up (P=.003), but this difference was no longer significant at 6-month follow-up. There were significantly more positive changes in harm reduction measures (quit attempts, number of cigarettes smoked per day, and nicotine dependence) at both 30-day and 6-month follow-up in the Tobacco Tactics group compared to the 1-800-QUIT-NOW group. Compared to participants in the 1-800-QUIT NOW group, significantly more of those in the Tobacco Tactics website group participated in the interventions, received phone calls and NRT, and found the intervention helpful. CONCLUSIONS: The Web-enhanced Tobacco Tactics website with telephone support showed higher efficacy and reach than the 1-800-QUIT-NOW intervention. Longer counseling sessions may be needed to improve 6-month cessation rates. TRIAL REGISTRATION: Clinicaltrials.gov NCT01124110; http://clinicaltrials.gov/ct2/show/NCT01124110 (Archived by WebCite at http://www.webcitation.org/6TfKN5iNL).

The impact of Sun Solutions educational interventions on select health belief model constructs.

The purpose of this study was to offer the Sun Solutions intervention to operating engineers (N = 232) to decrease sun exposure and skin cancer. The majority (82%) of the engineers worked outside between 10 a.m. and 3 p.m., 4 to 5 hours a day; 81.4% reported more than one sunburn during the past year and 70% sometimes or never used sunscreen compared to 30% who wore sunscreen approximately 50% or more of the time. Most reported that the intervention was helpful (97%), most were satisfied (96%) with the intervention, and 84% expressed a future intention to use sunscreen. Regarding sun protective behaviors, the intervention significantly improved perceived self-efficacy (p < .05) and increased perceived barriers (p < .05). Regarding sunburn and skin cancer, the intervention increased perceived benefits (p < .05), susceptibility (p < .05), and severity (p < .05) for sunburning, but not skin cancer (p > .10). The Sun Solutions intervention showed the potential to increase sunscreen use and decrease the risk of sunburn and skin cancer among operating engineers.

The development of the tobacco tactics website.

BACKGROUND: Web-based cessation interventions have been shown to reduce tobacco use, be more efficacious than self-help booklets, be more efficacious if they provide tailored messages, and enhance quit rates in conjunction with nicotine replacement therapy. OBJECTIVE: The objective of this study was to usability test and pilot test the Tobacco Tactics website for veterans. METHODS: Both formative and summative evaluations were used across three small successive studies to develop and test the Tobacco Tactics website for veterans, which was based on a prior face-to-face smoking cessation intervention. Once the website was developed, the research team and Web developers usability tested the website with 5 veteran smokers and former smokers. Feedback from the veterans was collected as they navigated each webpage, then used to revise the website. In pilot study 1, 9 veteran smokers were provided access to the website, and given a baseline and 30-day follow-up survey. In pilot study 2, 18 veteran smokers, who were also motivated to quit smoking, were recruited and randomized to either the Tobacco Tactics website plus nicotine replacement therapy or to the 1-800-QUIT-NOW telephone line. RESULTS: As a result of usability testing, more than 27 modifications were made to improve the website. In pilot study 1, 50% (3/6) veterans who entered the website had cut down on the number of cigarettes and 83% (5/6) found the website enjoyable, easy to read, easy to navigate, and would recommend the website to others. In pilot study 2, which included only smokers motivated to quit and also offered nicotine replacement therapy, seven-day point prevalence abstinence at 30-day follow-up was 40% (4/10) in the intervention group compared to 13% (1/8) in the control group. CONCLUSIONS: These preliminary results are promising and suggest the need for wider-scale testing of the Tobacco Tactics website for veterans.

Protocol of a randomized controlled trial of sun protection interventions for operating engineers.

BACKGROUND: Skin cancer are increasing and some types of skin cancer are among the most lethal cancers yet are easily preventable. However, sun protection interventions are rarely implemented among outdoor workers. Our prior work shows that Michigan Operating Engineers (heavy equipment operators) spend an average of 4-5 hours in the sun, about one-third reported getting sun burned at least once a summer, and over half burned more than once a summer. About three-quarters of the sample never or only sometimes used sun block. METHODS/DESIGN: Using the Health Belief Model as a guide, this randomized controlled trial (RCT) will test the efficacy of four sun protection interventions targeting Operating Engineers: a) education only; b) education and mailed sunscreen; c) education and text message reminders; and, d) education, mailed sunscreen, and text message reminders. Participations in the study will be offered during regularly scheduled safety trainings at the Local 324 Training Center. Pre- and post-intervention surveys will be collected to determine changes in sunscreen use and sun burning, the primary dependent variables. The analyses will include: a) paired t-tests to determine changes over time (from pre-intervention to post-intervention) in outcome variables (sunscreen use and burning) separately in the 4 intervention groups, b) Repeated Measures Analysis of Variance (RM-ANOVA) to compare the changes in outcomes across the 4 groups, and c) t-tests on change scores as follow-ups to the RM-ANOVA to determine exactly which groups differ from each other. DISCUSSION: Based on the outcome of this study, we will develop a RO1 for wider scale testing and dissemination in conjunction with the International Training Center which services North America (including the US, Mexico, and Canada). Wide scale dissemination of an efficacious sun protection intervention has the potential to substantially impact skin cancer rates among this population. The ultimate goal is for high reach, high efficacy, and low cost. TRIAL REGISTRATION: NCT01804595.

Employee attitudes about moving toward a smoke-free campus at a Veterans Affairs hospital.

BACKGROUND: Although Veterans Affairs (VA) hospitals have been smoke-free inside of buildings since 1991, smoke-free campuses have not been initiated. The purpose of this article is to describe staff attitudes regarding making the VA hospital a smoke-free campus except for the mandated smoking shelters. METHODS: In 2008, a cross-sectional, anonymous survey was conducted with a convenience sample of employees at a Midwestern VA (N = 397). RESULTS: Descriptive statistics showed that the vast number of employees were in support of a smoke-free campus (76%), relocating the smoking shelters (62%), and offering employees assistance to quit smoking (71%). Multivariate analyses showed that those who were nonsmokers, older, women, and higher educated were the greatest supporters of policies to support a smoke-free environment (p < .05). Write-in comments were generally favorable but also revealed employee resistance related to freedom, personal choice, and potential loss in productivity as smokers go further away from the building to smoke. CONCLUSIONS: VA hospitals have unique challenges in implementing smoke-free campus policies.

Dissemination of the nurse-administered Tobacco Tactics intervention versus usual care in six Trinity community hospitals: study protocol for a comparative effectiveness trial.

BACKGROUND: The objectives of this smoking cessation study among hospitalized smokers are to: 1) determine provider and patient receptivity, barriers, and facilitators to implementing the nurse-administered, inpatient Tobacco Tactics intervention versus usual care using face-to-face feedback and surveys; 2) compare the effectiveness of the nurse-administered, inpatient Tobacco Tactics intervention versus usual care across hospitals, units, and patient characteristics using thirty-day point prevalence abstinence at thirty days and six months (primary outcome) post-recruitment; and 3) determine the cost-effectiveness of the nurse-administered, inpatient Tobacco Tactics intervention relative to usual care including cost per quitter, cost per life-year saved, and cost per quality-adjusted life-year saved. METHODS/DESIGN: This effectiveness study will be a quasi-experimental design of six Michigan community hospitals of which three will get the nurse-administered Tobacco Tactics intervention and three will provide their usual care. In both the intervention and usual care sites, research assistants will collect data from patients on their smoking habits and related variables while in the hospital and at thirty days and six months post-recruitment. The intervention will be integrated into the experimental sites by a research nurse who will train Master Trainers at each intervention site. The Master Trainers, in turn, will teach the intervention to all staff nurses. Research nurses will also conduct formative evaluation with nurses to identify barriers and facilitators to dissemination.Descriptive statistics will be used to summarize the results of surveys administered to nurses, nurses' participation rates, smokers' receipt of specific cessation services, and satisfaction with services. General estimating equation analyses will be used to determine differences between intervention groups on satisfaction and quit rates, respectively, with adjustment for the clustering of patients within hospital units. Regression analyses will test the moderation of the effects of the interventions by patient characteristics. Cost-effectiveness will be assessed by constructing three ratios including cost per quitter, cost per life-year saved, and cost per quality-adjusted life-year saved. DISCUSSION: Given that nurses represent the largest group of front-line providers, this intervention, if proven effective, has the potential for having a wide reach and thus decrease smoking, morbidity and mortality among inpatient smokers. TRIAL REGISTRATION: Dissemination of Tobacco Tactics for Hospitalized Smokers NCT01309217.

Protocol of a randomized controlled trial of the Tobacco Tactics website for operating engineers.

BACKGROUND: Recent research indicates that 35 percent of blue-collar workers in the US currently smoke while only 20 percent of white-collar workers smoke. Over the last year, we have been working with heavy equipment operators, specifically the Local 324 Training Center of the International Union of Operating Engineers, to study the epidemiology of smoking, which is 29% compared to 21% among the general population. For the current study funded by the National Cancer Institute (1R21CA152247-01A1), we have developed the Tobacco Tactics website which will be compared to the state supported 1-800-QUIT-NOW telephone line. Outcome evaluation will compare those randomized to the Tobacco Tactics web-based intervention to those randomized to the 1-800-QUIT-NOW control condition on: a) 30-day and 6-month quit rates; b) cotinine levels; c) cigarettes smoked/day; d) number of quit attempts; and e) nicotine addiction. Process evaluation will compare the two groups on the: a) contacts with intervention; b) medications used; c) helpfulness of the nurse/coach; and d) willingness to recommend the intervention to others. METHODS/DESIGN: This will be a randomized controlled trial (N = 184). Both interventions will be offered during regularly scheduled safety training at Local 324 Training Center of the International Union of Operating Engineers and both will include optional provision of over-the-counter nicotine replacement therapy and the same number of telephone contacts. However, the Tobacco Tactics website has graphics tailored to Operating Engineers, tailored cessation feedback from the website, and follow up nurse counseling offered by multimedia options including phone and/or email, and/or e-community. Primary Analysis of Aim 1 will be conducted by using logistic regression to compare smoking habits (e.g., quit rates) of those in the intervention arm to those in the control arm. Primary analyses for Aim 2 will compare process measures (e.g., medications used) between the two groups by linear, logistic, and Poisson regression. DISCUSSION: Dissemination of an efficacious work-site, web-based smoking cessation intervention has the potential to substantially impact cancer rates among this population. Based on the outcome of this smaller study, wider scale testing in conjunction with the International Environment Technology Testing Center which services Operating Engineers across North America (including US, Mexico, and Canada) will be conducted. TRIAL REGISTRATION: NCT01124110.

Health behaviors of Operating Engineers.

Operating Engineers (heavy equipment operators in construction) may be at particular risk for heart disease and cancer related to their exposure to environmental dust and smoking, the sedentary nature of their job, and long hours of exposure to the sun. The aim of this study was to characterize the health behaviors of Operating Engineers. This cross-sectional survey from a convenience sample of Operating Engineers (N = 498) used validated instruments to measure smoking, drinking, diet, exercise, sleep, and sun exposure. Univariate and bivariate analyses to detect differences by age were conducted. The sample scored significantly worse on all five health behaviors compared to population norms. Those who were older were less likely to smoke and chew tobacco and more likely to eat fruits and vegetables. Many were interested in services to improve their health behaviors. Health behavior interventions are needed and wanted by Operating Engineers.