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Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:There is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and tobacco consumption remains the most preventable risk factor involved. Developing new tools to motivate patients towards cessation of smoking is a high priority. Information on the motivational value of giving the lung age and prevention opportunities is unknown in this high-risk population. METHODS/DESIGN:This article describes in detail a protocol developed to evaluate an intensive motivational tool, based on the individual risks of pulmonary damage and prevention opportunities. It is designed as a randomized, 12-month, follow-up, multicenter study. A minimum of 204 smokers will be included, aged 40?years and older, all of whom are patients diagnosed with either schizophrenia or bipolar disorder (BD). Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry, and the diagnosis will then be validated by a pneumologist and the lung age estimated. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3?months. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed. DISCUSSION:In the context of community care, screening and early detection of lung damage could potentially be used, together with mobile technology, in order to produce a prevention message, which may provide patients with SMI with a better chance of quitting smoking. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03583203 . Registered on 11 July 2018. Trial status: recruitment.

SUBMITTER: Jaen-Moreno MJ

PROVIDER: S-EPMC6332915 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial.

Jaén-Moreno María José MJ Feu Nuria N Redondo-Écija Justa J Montiel Francisco Javier FJ Gómez Cristina C Del Pozo Gloria I GI Alcalá Jose Ángel JÁ Gutiérrez-Rojas Luis L Balanzá-Martinez Vicente V Chauca Geli Marie GM Carrión Laura L Osuna Maria Isabel MI Sánchez María Dolores MD Caro Inmaculada I Ayora Miriam M Valdivia Francisca F López María Soledad MS Poyato Jose Manuel JM Sarramea Fernando F

Trials 20190114 1

<h4>Background</h4>There is an increased risk of premature death in people with severe mental illness (SMI). Respiratory disorders and cardiovascular disease are leading causes of increased mortality rates in these patients, and tobacco consumption remains the most preventable risk factor involved. Developing new tools to motivate patients towards cessation of smoking is a high priority. Information on the motivational value of giving the lung age and prevention opportunities is unknown in this ...[more]

PMID: 30642365

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Project description:BackgroundPeople with a serious mental illness are more likely to smoke more and to be more dependent smokers than the general population. This may be due to a wide range of factors that could include a common aetiology to both smoking and the illness, self medication, smoking to alleviate adverse effects of medications, boredom in the existing environment, or a combination of these factors. It is important to undertake this review to facilitate improvements in both the health and safety of people with serious mental illness who smoke, and to reduce the overall burden of costs (both financial and health) to the smoker and, eventually, to the taxpayer.ObjectivesTo review the effects of smoking cessation advice for people with serious mental illness.Search methodsWe searched the Cochrane Schizophrenia Group Specialized Trials Register up to 2 April 2015, which is based on regular searches of CENTRAL, BIOSIS, PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and trial registries. We also undertook unsystematic searches of a sample of the component databases (BNI, CINHAL, EMBASE, MEDLINE, and PsycINFO), up to 2 April 2015, and searched references of all identified studiesSelection criteriaWe planned to include all randomised controlled trials (RCTs) that focussed on smoking cessation advice versus standard care or comparing smoking cessation advice with other more focussed methods of delivering care or information.Data collection and analysisThe review authors (PK, AC, and DB) independently screened search results but did not identify any trials that fulfilled the inclusion criteria of this review.Main resultsWe did not identify any RCTs that evaluated advice regarding smoking cessation for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to smokers with serious mental illness is possible.Authors' conclusionsPeople with serious mental illness are more likely to smoke than the general population. Yet we could not find any high quality evidence to guide the smoking cessation advice healthcare professionals pass onto service users. This is an area where trials are possible and needed.

Project description:BackgroundImplementation researchers have sought ways to use simulations to support the core components of implementation, which typically include assessing the need for change, designing implementation strategies, executing the strategies, and evaluating outcomes. The goal of this paper is to explain how agent-based modeling could fulfill this role.MethodsWe describe agent-based modeling with respect to other simulation methods that have been used in implementation science, using non-technical language that is broadly accessible. We then provide a stepwise procedure for developing agent-based models of implementation processes. We use, as a case study to illustrate the procedure, the implementation of evidence-based smoking cessation practices for persons with serious mental illness (SMI) in community mental health clinics.ResultsFor our case study, we present descriptions of the motivating research questions, specific models used to answer these questions, and a summary of the insights that can be obtained from the models. In the first example, we use a simple form of agent-based modeling to simulate the observed smoking behaviors of persons with SMI in a recently completed trial (IDEAL, Comprehensive Cardiovascular Risk Reduction Trial in Persons with SMI). In the second example, we illustrate how a more complex agent-based approach that includes interactions between patients, providers and site administrators can be used to provide guidance for an implementation intervention that includes training and organizational strategies. This example is based in part on an ongoing project focused on scaling up evidence-based tobacco smoking cessation practices in community mental health clinics in Maryland.ConclusionIn this paper we explain how agent-based models can be used to address implementation science research questions and provide a procedure for setting up simulation models. Through our examples, we show how what-if scenarios can be examined in the implementation process, which are particularly useful in implementation frameworks with adaptive components.

Project description:Significant progress has been made in reducing the prevalence of tobacco use in the United States. However, tobacco cessation efforts have focused on the general population rather than individuals with mental illness, who demonstrate greater rates of tobacco use and nicotine dependence.To assess whether declines in tobacco use have been realized among individuals with mental illness and examine the association between mental health treatment and smoking cessation.Use of nationally representative surveys of noninstitutionalized US residents to compare trends in smoking rates between adults with and without mental illness and across multiple disorders (2004-2011 Medical Expenditure Panel Survey [MEPS]) and to compare rates of smoking cessation among adults with mental illness who did and did not receive mental health treatment (2009-2011 National Survey of Drug Use and Health [NSDUH]).The MEPS sample included 32,156 respondents with mental illness (operationalized as reporting severe psychological distress, probable depression, or receiving treatment for mental illness) and 133,113 without mental illness. The NSDUH sample included 14,057 lifetime smokers with mental illness.Current smoking status (primary analysis; MEPS sample) and smoking cessation, operationalized as a lifetime smoker who did not smoke in the last 30 days (secondary analysis; NSDUH sample).Adjusted smoking rates declined significantly among individuals without mental illness (19.2% [95% CI, 18.7-19.7%] to 16.5% [95% CI, 16.0%-17.0%]; P?<?.001) but changed only slightly among those with mental illness (25.3% [95% CI, 24.2%-26.3%] to 24.9% [95% CI, 23.8%- 26.0%]; P?=?.50), a significant difference in difference of 2.3% (95% CI, 0.7%-3.9%) (P?=?.005). Individuals with mental illness who received mental health treatment within the previous year were more likely to have quit smoking (37.2% [95% CI, 35.1%-39.4%]) than those not receiving treatment (33.1% [95% CI, 31.5%-34.7%]) (P?=?.005).Between 2004 and 2011, the decline in smoking among individuals with mental illness was significantly less than among those without mental illness, although quit rates were greater among those receiving mental health treatment. This suggests that tobacco control policies and cessation interventions targeting the general population have not worked as effectively for persons with mental illness.

Project description:IntroductionIndividuals with serious mental illness (SMI) smoke at rates two to three times greater than the general population but are less likely to receive treatment. Increasing our understanding of correlates of smoking cessation behaviors in this group can guide intervention development.Aims and methodsBaseline data from an ongoing trial involving smokers with SMI (N = 482) were used to describe smoking cessation behaviors (ie, quit attempts, quit motivation, and smoking cessation treatment) and correlates of these behaviors (ie, demographics, attitudinal and systems-related variables).ResultsForty-three percent of the sample did not report making a quit attempt in the last year, but 44% reported making one to six quit attempts; 43% and 20%, respectively, reported wanting to quit within the next 6 months or the next 30 days. Sixty-one percent used a smoking cessation medication during their quit attempt, while 13% utilized counseling. More quit attempts were associated with lower nicotine dependence and carbon monoxide and greater beliefs about the harms of smoking. Greater quit motivation was associated with lower carbon monoxide, minority race, benefits of cessation counseling, and importance of counseling within the clinic. A greater likelihood of using smoking cessation medications was associated with being female, smoking more cigarettes, and receiving smoking cessation advice. A greater likelihood of using smoking cessation counseling was associated with being male, greater academic achievement, and receiving smoking cessation advice.ConclusionsMany smokers with SMI are engaged in efforts to quit smoking. Measures of smoking cessation behavior are associated with tobacco use indicators, beliefs about smoking, race and gender, and receiving cessation advice.ImplicationsConsideration of factors related to cessation behaviors among smokers with SMI continues to be warranted, due to their high smoking rates compared to the general population. Increasing our understanding of these predictive characteristics can help promote higher engagement in evidence-based smoking cessation treatments among this subpopulation.

Project description:BACKGROUND:Smoking rates of Australians with severe mental illness (SMI) are disproportionately higher than the general population. Despite the rapid growth in mobile health (mHealth) apps, limited evidence exists to inform their design for SMI populations. OBJECTIVE:This study aimed to explore the feasibility, acceptability, and utility of adapting a novel smoking cessation app (Kick.it) to assist smokers with SMI to prevent smoking relapse and quit. METHODS:Using co-design, two in-depth interviews with 12 adult smokers and ex-smokers with SMI were conducted in this qualitative study. Stage 1 interviews explored participants' smoking-related experiences and perceptions of social support for smoking cessation, informed the development of the stage 2 interview schedule, and provided context for participants' responses to the second interview. Stage 2 interviews explored participants' perceptions of the feasibility, utility, and acceptability of the app features for SMI populations. RESULTS:People with SMI perceived mHealth interventions to support their quit smoking attempts as feasible, acceptable, and useful. Key emerging themes included personalization of the app to users' psychosocial needs, a caring app to mediate self-esteem and self-efficacy, an app that normalizes smoking relapse and multiple quit attempts, a strong focus on user experience to improve usability, and a social network to enhance social support for smoking cessation. CONCLUSIONS:This study gained an in-depth understanding of the lived experiences of smoking and quitting among people with SMI and their perception of the Kick.it app features to help inform the tailoring of the app. Specific program tailoring is required to assist them in navigating the complex interactions between mental illness and smoking in relation to their psychosocial well-being and capacity to quit. This study describes the adaptations required for the Kick.it app to meet the specific needs and preferences of people with SMI. Results of this study will guide the tailoring of the Kick.it app for SMI populations. The study findings can also inform a co-design process for the future development and design of smoking cessation apps for SMI populations.

Dataset Information

Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial.

Publications

Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk - TIMER-): study protocol for a randomized controlled trial.

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