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

Abstract 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 NCT01804595http://deepblue.lib.umich.edu/bitstream/2027.42/112879/1/12889_2013_Article_5170.pd

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

Abstract 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 NCT01309217http://deepblue.lib.umich.edu/bitstream/2027.42/109462/1/13063_2011_Article_1134.pd

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. Conclusions 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

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

Abstract 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, NCT0130921

Use of comprehensive recruitment strategies in the glycemia reduction approaches in diabetes: A comparative effectiveness study (GRADE) multi-center clinical trial

Background/Aims: We present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care. Methods: Site selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems. Results: The study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age ≧60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks. Conclusion: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>NCT01124110</p

Randomized controlled trial of the Tobacco Tactics website versus 1-800-QUIT-NOW telephone line among Operating Engineers

http://deepblue.lib.umich.edu/bitstream/2027.42/109453/1/12971_2014_Article_191.pd

Pregnancy in a Patient with an Intra-Abdominal Levonorgestrel-Releasing Intrauterine System

Background: The levonorgestrel-releasing-intrauterine system (LNG-IUS) is a frequently used method of contraception worldwide. A rare, but bothersome complication of the LNG-IUS is a perforation of the uterus after insertion. Knowledge about the preferred management option in case of an intra-abdominally situated LNG-IUS during pregnancy is lacking. Case: This case report concerns a 33-year-old patient who became pregnant despite having an intra-abdominally situated LNG-IUS. The patient was counseled about the management options. The advantages and disadvantages of expectant management versus laparoscopic removal of the LNG-IUS were discussed, and the patient preferred removal of the IUS. The procedure was performed laparoscopically at 15 weeks of pregnancy. Results: The IUS was removed without complications, and the patient's pregnancy proceeded uneventfully. Conclusions: Considering the degree of evidence, it is important to make a tailor-made decision in case of a pregnancy with a perforated LNG-IUS