Ballbè et al. Trials (2019) 20:38 https://doi.org/10.1186/s13063-018-3106-5 STUDY PROTOCOL Open Access Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial Montse Ballbè1,2,3†, Cristina Martínez1,2,4,5*† , Ariadna Feliu1,2,5, Núria Torres6, Gemma Nieva7, Cristina Pinet8, Antònia Raich9, Sílvia Mondon3, Pablo Barrio3, Rosa Hernández-Ribas5,10, Jordi Vicens11, Sílvia Costa8,12, Jordi Vilaplana13, Laura Alaustre6, Eva Vilalta6, Roser Blanch6, Susana Subirà11, Eugeni Bruguera7, Josep Maria Suelves14, Joseph Guydish15 and Esteve Fernández1,2,5 Abstract Background: Up to 75% of inpatients with mental disorders smoke, and their life expectancy is decreased by up to 25 years compared to the general population. Hospitalized patients without monitoring after discharge quickly return to prehospitalization levels of tobacco use. The aim of the 061 QuitMental study is to assess the effectiveness of a multicomponent and motivational telephone-based intervention to stop smoking through a quitline addressed to smokers discharged from mental health hospital wards. Methods: A pragmatic randomized controlled trial, single blinded, will include 2:1 allocation to the intervention group (IG) and the control group (CG). The IG will receive telephone assistance to quit smoking (including psychological and psychoeducational support, and pharmacological treatment advice if required) proactively for 12 months, and the CG will receive only brief advice after discharge. The sample size, calculated with an expected difference of 15 points on smoking abstinence between groups (IG, 20% and CG, 5%), α = 0.05, β = 0.10, and 20% loss, will be 334 participants (IG) and 176 participants (CG). Participants are adult smokers discharged from psychiatric units of five acute hospitals. Measurements include dependent variables (self-reported 7-day point prevalence smoking abstinence (carbon monoxide verified), duration of abstinence, number of quit attempts, motivation, and self-efficacy to quit) and independent variables (age, sex, and psychiatric diagnoses). In data analysis, IG and CG data will be compared at 48 h and 1, 6, and 12 months post discharge. Multivariate logistic regression (odds ratio; 95% confidence interval) of dependent variables adjusted for potential confounding variables will be performed. The number needed to treat to achieve one abstinence outcome will be calculated. We will compare the abstinence rate of enrolled patients between groups. (Continued on next page) * Correspondence: cmartinez@iconcologia.net † Montse Ballbè and Cristina Martínez contributed equally to this work. 1 Tobacco Control Unit, Cancer Control and Prevention Program, Institut Català d’Oncologia-ICO, Av. Granvia de L’Hospitalet 199-203, L’Hospitalet de Llobregat, 08908 Barcelona, Spain 2 Cancer Control and Prevention Group, Institut d’Investigació Biomèdica de Bellvitge-IDIBELL, Av. Granvia de L’Hospitalet 199-203, L’Hospitalet de Llobregat, 08908 Barcelona, Spain Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Ballbè et al. Trials (2019) 20:38 Page 2 of 11 (Continued from previous page) Discussion: This trial evaluates an innovative format of a quitline for smokers with severe mental disorders regardless of their motivation to quit. If effective, the pragmatic nature of the study will permit transfer to routine clinical practice in the National Health System. Trial registration: ClinicalTrials.gov, NCT03230955. Registered on 24 July 2017. Keywords: Mental disorders, Clinical trial, Smoking cessation, Telephone, Quitlines, Key points [18]. Historically, tobacco consumption has been considered a “minor problem” among patients with mental disorders; it  This study is the first designed specifically for was believed that these patients were not interested in quit- mental health patients with a long-term follow-up of ting [19] and even that smoking helped patients control 1 year, as other studies have performed follow-up their disorder [20]. Some of these beliefs may be reflected in periods of 6–7 months maximum. smoking cessation research. While there have been approxi-  This trial evaluates an innovative quitline for mately 9000 smoking cessation trials among general popula- smokers with severe mental disorders regardless of tion smokers, there have been only 20 such trials among their motivation to quit. patients with mental disorders [21]. The few studies that  If effective, the pragmatic nature of the study will have been done, however, indicate that patients with mental permit transfer to routine clinical practice in the disorders can achieve significant rates of abstinence [20]. National Health System. Over the last decade, some jurisdictions have imple- mented cost-effective measures, as proposed by the Background World Health Organization (WHO), to curb smoking Smoking prevalence has declined over the last decade in among persons with mental disorders [20]. These mea- developed countries. However, in some vulnerable popu- sures are mainly policies for smoke-free areas, treatment lations, such as people suffering from mental disorders, to quit smoking, and community measures of sustained the prevalence has not followed this trend [1–3]. People support to quit [22]. with mental disorders are more likely to smoke, and the Hospitalization in smoke-free psychiatric centers in- greater number of lifetime psychiatric diagnoses, the creases the quality of life in both patients and professionals, greater the probability of smoking [4]. In Catalonia, and decreases the exposure to second-hand smoke [23]. In 74.4% of patients hospitalized for mental disorders addition, such policies increase quit attempts by patients smoke [5], which is three times higher than the smoking and their expectations of staying abstinent [24, 25]. Only rate (26.9%) in the general population [6]. In addition, total smoke-free areas completely protect patients from these patients start to smoke at an early age, experience second-hand smoke [26]. In Spain, the tobacco control Law higher levels of nicotine dependence, and have more 42/2010 bans smoking in both indoors and outdoors areas difficulty quitting [7, 8]. of acute hospitals including psychiatric units. This legal The reasons for higher consumption of tobacco among framework, which implies abstinence of patients during people with mental disorders are not clear. Several expla- hospitalization, creates a unique opportunity to promote nations have been suggested, including genetic factors or/ smoking cessation among patients with mental disorders. and a low socioeconomic level [9]. Another explanation Concerning treatment to quit smoking, the use of sometimes invoked is the self-medication hypothesis, self-help materials, telephone advice, and psychological and which suggests that patients with mental disorders, and pharmacological treatments have been shown to be effec- particularly those with schizophrenic diagnoses, smoke to tive [27, 28]. Although interventions to promote smoking ameliorate their symptoms. However, this hypothesis is in- cessation among patients with mental disorders aim to creasingly rejected [10, 11]. achieve abstinence, it is often necessary to first promote Tobacco is the cause of death for 48–53% of people motivation to quit [27]. Thus, these patients would be able with mental illness [12, 13] primarily for cardiovascular to make serious attempts to quit smoking when hospitals and respiratory diseases, cancer, and diabetes [14]. For have trained professionals to respond to their needs and people with severe mental illness, life expectancy is offer them pharmacological and psychological aids [29]. In- reduced up to 10–17 years, mainly for illnesses caused terventions that combine pharmacological treatment and or worsened by smoking [15–17]. The persistent high psychological therapy—primarily cognitive-behavioral psy- prevalence of tobacco use within this population high- chological treatment—increase the likelihood of tobacco lights how public health and healthcare services have cessation in patients with mental disorders [30–32]. How- neglected the needs of this disadvantaged population ever, without patient monitoring after discharge, smoking is Ballbè et al. Trials (2019) 20:38 Page 3 of 11 restored to previous levels in 2 weeks [33, 34]. Only a few a. to assess the effectiveness of the intervention in clinical trials [21, 35, 36] have demonstrated the efficacy of relation to the characteristics of the smokers multicomponent interventions (which included motiv- (mental disorder, comorbidity, age, sex, and ational, psychosocial, and pharmacological components) educational level and occupation); addressed to patients with mental disorders after discharge. b. to compare the levels of motivation to quit In these studies, the intervention group showed higher ab- smoking, self-efficacy, attempts to quit smoking, stinence rates, more quit attempts, and fewer cigarettes per and the likelihood of smoking abstinence in the day as compared to controls [21, 35, 36]. In addition, as intervention group and the control group; shown in the general population, it is likely that patients c. to describe the use and satisfaction with the quitline with a mental disorder who quit smoking also reduce their in the intervention group and the control group; and levels of anxiety, increase their quality of life, and obtain d. to assess the feasibility of this intervention to better results in abstinence from other drugs [37]. systematically offer it at a community level. In relation to community measures, “quitlines” (i.e., telephone counseling) stand out as an effective support These objectives will be analyzed by comparing the re- in the general population [38]. However, this resource sults obtained from the IG and the CG at several time has so far been little used among populations with men- points post discharge: 48 h and 1, 6, and 12 months (Fig. 1). tal disorders [39]. The few studies conducted with men- The hypotheses of this study are the following: tally ill patients showed that a quitline intervention combined with nicotine replacement therapy (NRT) a. IG participants, as compared to CG participants, slightly but significantly increased 7-day point preva- will demonstrate higher rates of biochemically lence abstinence at 6 months follow-up, reduced the verified 7-day point prevalence smoking abstinence, number of cigarettes consumed per day, and increased at all evaluation time points (48 h and 1, 6, and 12 readiness to quit smoking [36, 39]. months post discharge). In Catalonia, the health information and care telephone b. IG participants, as compared to CG participants, line “061 CatSalut Respon” provides a free support program will experience longer periods of sustained to quit smoking, which acts as a quitline. A nursing team, abstinence as demonstrated by sequential experts in telephone assistance and smoking cessation, pro- biochemically verified 7-day point prevalence smok- vide an individualized intervention to quit smoking through ing abstinence, at all evaluation time points. intensive care for 1 year. However, this service has not so c. IG participants who continue to smoke, as far been used for patients with mental disorders. Quitlines compared to CG participants, will show greater may have some advantages over other cessation services, as reduction in the number of cigarettes smoked per they can increase access, are less costly than face-to-face day, at all evaluation time points. visits [38], and offer a solution to the lack of systematic in- d. IG participants who continue to smoke, as terventions in patients with mental disorders especially compared to CG participants, will show an increase after discharge [34, 40]. However, contact with the quitline in the progression of their readiness to quit is usually initiated by the smoker, and is not usually smoking, based on stages of change, at all initiated proactively by the treatment provider. Therefore, evaluation time points. we propose a pragmatic randomized controlled trial that e. IG participants, as compared to CG participants, uses the existing resources of 061 CatSalut Respon to will have a higher level of self-efficacy to quit at all engage patients with mental disorders identified during evaluation time points. hospitalization in acute psychiatric hospital units. The aim of this study is to assess the effectiveness Methods of a telephone-based (quitline) intervention for smo- This project arises from the collaboration between the king cessation addressed to smokers with severe men- Catalan Institute of Oncology, the Public Health Agency of tal disorders after discharge from adult inpatient Catalonia, and the 061 CatSalut Respon program, which is acute units (the 061 QuitMental study). The interven- a public telephone service from the National Health System tion group (IG) will receive a telephone intervention about health topics addressed to all citizens. to quit smoking (including psychological and psychoe- ducational support and pharmacological treatment ad- Design vice, if required) proactively for 12 months, and the This study is a pragmatic randomized controlled trial control group (CG) will receive only brief counseling (RCT) with two groups: intervention group (n = 334) and after discharge. control group (n = 176). The subjects will be followed up The specific objectives of the 061 QuitMental study to 12 months. The duration of the study is 3 years and is are as follows: divided into three phases: phase I, intervention design and Ballbè et al. Trials (2019) 20:38 Page 4 of 11 Fig. 1 Study variables and collection time points. GHQ-12 12-item version of the General Health Questionnaire pilot study for 1 month; phase II, recruitment during 24 care hospitals of Barcelona (Hospital Clinic i Provincial months; and phase III, analyses of the effectiveness of the de Barcelona, Hospital de la Santa Creu i Sant Pau, intervention, publication of the results, and dissemination Hospital Universitari Vall d’Hebron, Hospital Universitari (6 months after phase II). de Bellvitge, and Hospital Hestia Duran i Reynals). The in- clusion criteria are: patients who consider themselves Study population smokers, both daily and occasional smokers (less than 1 The study population includes smokers with mental dis- cigarette per day); adults of both sexes aged 18–76 years; orders admitted to the mental health wards of five acute patients who have stayed in an acute or detoxification Ballbè et al. Trials (2019) 20:38 Page 5 of 11 mental health unit for more than 24 h; patients with a Secondary outcome measure We will also record other telephone, fixed or mobile; residents in the metropolitan smoking variables such as continuous abstinence. More- area of Barcelona; and patients who provide informed over, for nonabstinent patients we will ask about their consent. The exclusion criteria are: patients discharged tobacco use (quantity), type of tobacco consumed from the psychiatric emergency rooms; patients with de- (cigarette/cigar/other), number of quit attempts, and mentia or brain damage; patients who do not speak or other variables included in the “smoking” section in read Spanish or Catalan; pregnant women; patients with Fig. 1. Moreover, using an ad-hoc Likert scale from 0 to hearing and/or speech deficit; patients who are trying to 10 we will evaluate the level of self-efficacy to quit or re- quit smoking in another center or using another interven- duce consumption, the intention to quit, and the tion; patients who have voluntarily requested discharge; intention to reduce consumption. The individual’s will- patients who are discharged to another inpatient unit; and ingness to quit will be also evaluated according to the patients who plan to move their household outside the Prochaska and Di Clemente Stages of Change model, Barcelona metropolitan area within the next 24 months. which measures four stages of readiness to quit smoking Clinical professionals (coordinated by a researcher (precontemplation, contemplation, action, and main- from each hospital) will evaluate whether patients met tenance) [43]. the inclusion/exclusion criteria. Sample size and randomization Independent variables Data from the five centers indicate that each year 1744 Using a data collection form we will collect the following patients are admitted to their acute and detoxification information: mental health units, of which 70% are expected to be smokers [5]. Setting a risk of α = 0.05 and β = 0.10, and a) Sociodemographic data such as sex, age, with 2:1 randomization, 334 subjects are required in the occupation, and highest level of education attained. IG arm and 167 in the CG arm to detect a statistically b) History and pattern of tobacco use, which will significant difference of 15 percentage points between include information to obtain the Heavy Smoking the proportion of abstinence in both groups (IG abstin- Index as a measure of nicotine dependence self- ence rate, 20% and CG abstinence rate, 5%) after 12 reported by the participants [44, 45]. months, with an estimated 20% loss to follow-up. Hence, c) General health data, such as self-perceived general participants will be randomized into the IG and the CG health assessment by the question “how would you with 2:1 allocation using mapping software. The main describe your health in a general way?”, and other reason for the unequal allocation (2 IG:1 CG) was eth- medical conditions. ical, in order to maximize the number of participants in- d) Mental health data, such as diagnoses according to cluded in the treatment group, as the treatment is the DSM-5 groups of diagnostic criteria [46] and supposed to be beneficial for them. psychotropic treatment, will be obtained from par- ticipants’ clinical records by the researchers, Variables whereas information about the number of emer- Outcome measures gency room visits, readmissions to psychiatric wards, and evaluation of mental distress measured Primary outcome measure Self-reported 7-day point using the 12-item version of the General Health prevalence smoking abstinence, biochemically verified Questionnaire (GHQ-12) [47, 48] will be self- with expired carbon monoxide (CO) measures, is the reported by the participants. primary outcome. Seven days of abstinence has been e) Variables of smoking cessation services reported by chosen as a consumption measure [41]. This variable the participants, such as, if used, any other strategy will be recorded in every call of the intervention (48 h, 1 for tobacco cessation, will be registered. It will also week, 15 days, and 1, 3, 6, and 12 months post be recorded whether the patient has actively spoken discharge). Abstinent subjects at 1, 6, and 12 months with their psychiatrist, psychologist, nurse, or family in either of both groups (IG or CG) will be invited to doctor about their participation in the quitline, attend a consultation at their hospital to verify their whether the professionals have agreed, and whether abstinence through the detection of exhaled carbon they have helped them, to assess the possible monoxide. The abstinence rate between the IG and influence of these variables on the success the CG will be compared at 1, 6, and 12 months. In (or failure) of the intervention. each call, nicotine withdrawal symptoms will be assessed according to the scale proposed by Hughes Collected variables and their collection frequency are and Hatsukami [42]. detailed in Fig. 1. Ballbè et al. Trials (2019) 20:38 Page 6 of 11 Procedure CG subjects will be contacted after the first 48 h fol- The research team designed a telephone-based interven- lowing discharge by nonclinical telephone assistants who tion with a proactive approach to help patients quit smok- will provide brief advice (only in the first call) and col- ing after discharge from hospitals. The intervention will lect data for comparison, at this time (48 h), 1, 6, and 12 take into account the recommendations made by a group months post discharge. The investigators trained the of experts in the design of telephone-based interventions nonclinical telephone assistants in order to conduct the (quitlines) aimed at patients with mental illnesses [39]. interviews in a neutral tone following the wording of The intervention will also be based on the protocol of the each of the questions and not giving health recommen- general quitline of 061 CatSalut Respon and a clinical dations, as they are not qualified to do so. For patients intervention guide for smoking cessation in patients with who express their desire to quit, telephone assistants mental disorders [28]. Depending on the case, the inter- suggest they talk with their outpatient clinic doctor, vention will be directed to: increase motivation to quit; nurse, or psychologist to receive aid. achieve abstinence; prevent relapses if achieving abstin- For those patients who met the criteria, clinicians will ence; reduce consumption and increase motivation to quit invite them to participate and will deliver an informative smoking when the patient is still not ready or motivated leaflet of the study (Additional file 1). Informed consent to quit; and/or recommend pharmacological treatment. will be requested within 24 h before discharge (see Fig. 2, The intervention will be conducted by 061 CatSalut recruiting process). Clinicians will register participants’ Respon nurses within the first 48 h, 1 week, 15 days, and data in a software program that will be used for 1, 3, 6, 9, and 12 months after discharge. IG subjects will randomization and to transfer this information to 061 be contacted by the trained nurses and will provide an CatSalut Respon to contact the participants. All of intervention strategy adapted to each patient situation in this baseline information is registered in the software each call (whether they smoke, take pharmacological during the hospital stay. Finally, on the day of dis- treatment to quit, are ready for a quitting day calls, “D charge the subjects are automatically assigned ran- day”, etc.) according to an algorithm procedure (Fig. 1). domly to one of the two groups (IG or CG) by the The first telephone call at 48 h will serve as a starting software. The study is blinded to prevent profes- point for the quitline intervention outside the hospital sionals from the hospital, and patients, from knowing and to take baseline data post discharge. to which group they have been assigned. Fig. 2 Recruiting process Ballbè et al. Trials (2019) 20:38 Page 7 of 11 Telephone-based intervention components Data collection The intervention is based on cognitive-behavioral therapy. A computer-specific application for the study will be de- The intervention will include components based on signed for data recording and management, including Bandura’s social learning theory, social cognitive theory randomization. The software will be created following [49], and the transtheoretical model of change [43]. This the current standards of security, privacy, and confiden- theory allows evaluating the patient motivation phase and tiality. All study researchers will have access to the appli- adapting the interventions according to each phase [27]. cation using a personal username and password. These components are included in the training cur- Clinicians from each center will only be able to register riculum aimed at 15 nurses from 061 CatSalut Respon and have access to review information from patients who will deal with patients with mental disorders from from their own center. The 061 CatSalut Respon nurses the IG. The specific training will include the definition will obtain data from patients registered in the five cen- and description of the most common mental disorders, ters to do the telephone intervention. Collected data will symptoms, usual treatments, warning signs, and man- be exclusively used to carry out the intervention (IG or agement, as well as the peculiarities of the smoking CG), supervision, and evaluation. Patients will be in- cessation treatment in these patients (Table 1). formed about the application uses and purposes, the ex- Trained nurses will help those patients to identify istence of their profile including their personal details, their barriers and opportunities to achieve abstinence. and the person responsible for their treatment, along They will also help them to set objectives, strategies with their access rights, rectification, cancellation, and to tackle “craving”, positive reinforcement toward pro- opposition. Once the patient has given his/her consent, gress, and increase their self-efficacy. If necessary, clinicians will input data from the basal interview into nurses will recommend NRT according to the proto- the application. col of a clinical guideline [28], as it is a medication Once the study is completed, professionals from the that does not require medical prescription in Spain. hospitals and 061 CatSalut Respon will no longer have Nurses will have a written protocol and an algorithm access to the database. The ICO is responsible for prop- to deliver the intervention strategy according to each erly saving the files and its protection by encrypted se- patient’s situation (Fig. 3). Nurses will recommend the cure systems, until its eventual destruction (5 years after patients inform their psychiatrist and/or psychologist study completion). The database will not identify pa- that they are receiving this telephone-based interven- tients in any way, creating an individual encrypted code. tion to quit smoking. Data collected during the study will be included in a file All patients in the intervention group will receive registered by the Spanish Data Protection Agency. eight telephone calls during 1 year (48 h, 1 week, 15 The intervention and the computer application will be days, and 1 , 3 , 6 , 9, and 12 months post discharge), firstly piloted in the five participating centers for 1 regardless of whether they continue smoking or not. month for its evaluation before starting the study, to as- The intervention lasts for 12 months, unless the pa- sess the adequacy of the fieldwork circuit and make tient rejects to continue participating in the study. minor changes in the protocol, if necessary. The intervention adapts its objectives depending on the smoking status of the patient in each call (see Fig. 3 in which the different strategies are explained Data analysis according to the smoking status assessed in each call, The abstinence prevalence will be analyzed by groups whether he/she is abstinent or not, is willing to allo- taking into account sociodemographic determinants. cate a “D day”, takes NRT). Logistic regression analysis will be used to assess the ef- fectiveness of the intervention (OR and 95% confidence interval) with regard to the CG, using the different Table 1 Components of the formative curriculum dependent variables previously described (abstinence, re- • Mental disorders, symptomatology, and general treatment duction of the number of cigarettes, motivation, etc.). • Content, extension, and frequency of the proactive calls Thus, the IG and the CG will be compared in different moments of the follow-up. In addition to randomization, • Withdrawal syndrome assessment in the mental health context to warrant comparability, we will fit multivariate logistic • Pharmacological recommendations about nicotine replacement therapy models to adjust for potential confounding variables. All analyses will be carried out by “intention to treat”, to • Peculiarities of smoking cessation treatment in patients with mental disorders, alert signs, and management take into account possible losses during follow-up. We will also analyze resource use, such as the number of • Motivational intervention calls, satisfaction with the quitline, and type of treatment • Communication strategies offered, among others. Ballbè et al. Trials (2019) 20:38 Page 8 of 11 Fig. 3 Strategy intervention in the intervention group. NRT nicotine replacement therapy Ballbè et al. Trials (2019) 20:38 Page 9 of 11 Ethical considerations in addition to assessing smoking cessation. The main ex- The intervention protocol has been approved by the Ethics pected outcome is an increased rate of CO-verified 7-day Committee for Clinical Research (CEIC) from the Bellvitge point prevalence abstinence in the intervention group, as Biomedical Research Institute (IDIBELL) (reference: PR276/ compared with the control group. All smokers, regardless 16), as well as by the Ethics Committee of each of the five of their level of motivation to quit, will be eligible to par- participating hospitals. The study protocol has been regis- ticipate. Analyses will consider covariates such as psychi- tered under ClinicalTrials.gov (NCT03230955, approved 24 atric diagnoses, use of other psychoactive substances, July 2017). psychological distress, mental illness relapse and rehospi- At all times, requirements established by Law 14/2007, talization, and sociodemographic variables. Other relevant of 3rd July, on Biomedical Research will be met by re- outcomes for comparison will include the level of motiv- searchers. The study will take place in compliance with ation to quit, number of quit attempts, and level of psy- the Declaration of Helsinki. chological distress. Smokers who meet the inclusion criteria will receive a There are several potential limitations. In Catalonia, brief explanation of the purpose of the study. They will Spain, patients who have high motivation to quit also be given an information sheet and they will be asked smoking at the time of discharge from acute mental to fill in the informed consent. The information will be health hospitals are referred to a face-to-face intensive protected according to the standards established by smoking cessation intervention with free pharmaco- Spanish Law 15/1999 on the Protection of Personal Data. therapy for smoking cessation. These patients are ex- The study termination criteria are the following (the cluded from our study and, therefore, our sample first to be met): conclusion of the study procedures; if a does not include patients with high motivation to quit patient explicitly states that he/she do not want to con- smoking. Nonetheless, we will assess all patients who tinue to participate in the study; and if a patient has re- meet the study inclusion criteria and compare demo- peatedly not been located in each of the off-tracking graphic, psychiatric, and tobacco use characteristics of visits from both the intervention or control group dur- those who accept or decline enrollment. Another ing the 12 months of tracking. limitation, derived from the long-term follow up de- sign, is loss to follow-up that could bias follow-up Discussion findings. We will perform an attrition analysis com- Smoking has serious implications for people with severe paring characteristics of those followed to those not mental illnesses, mainly in terms of quality of life and followed at each time point. In addition, to preserve mortality but also in economic costs and marginalization. statistical power needed to observe a 15% difference Hospital mental health units are an optimal setting to in the quit rate between conditions, we have in- intervene and promote patient engagement in tobacco creased the baseline sample size to accommodate an cessation treatment [21]. For this reason, it is necessary to anticipated 20% loss to follow-up at 12 months. To offer and improve a variety of interventions to motivate increase follow-up data collection, clinicians will col- and promote cessation among these patients. lect contact telephone numbers for the participant Patients with mental health disorders are usually excluded and at least two family members or caregivers. There from smoking cessation trials [20], and consequently there is potential for underreporting of smoking status at is scarce evidence for the effectiveness of quitlines in this follow-up. Participants reporting nonsmoking status at population. As these patients usually have high comorbidity follow-up receive a reminder and a clinic appoint- and high smoking dependence, they represent a complex ment to complete exhaled CO testing. population for smoking cessation intervention. They need If effective, this intervention could be included in the more intensive counseling, pharmacological intervention, Catalan Health System and regularly offered to mental and longer follow-up support to achieve cessation [20], so health patients who smoke, no matter their motivation there is a need to tailor these strategies to this population to quit. We need to offer a wide range of possibilities to [50]. Only a few studies of quitline effectiveness have in- intervene in smoking cessation in this population as cluded mental health patients and, usually, quitline interven- their smoking prevalence has not decreased in the last tions have not been tailored to this population [51]. This is decade (Additional file 2). the first randomized trial to test a quitline intervention specifically tailored to the needs of mental health patients that incorporates a long-term follow-up of 1 year, since Additional files other studies have performed follow-up periods from 6 to 7 months [52] and with smaller samples [53]. Additional file 1: Informative leaflet for the quitline (DOCX 529 kb) The large sample, together with the long follow-up Additional file 2: SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents (DOC 120 kb) period, will allow us to perform other subgroup analyses Ballbè et al. Trials (2019) 20:38 Page 10 of 11 Acknowledgements Author details 1 The authors thank the group of nurses who work in the implementation of Tobacco Control Unit, Cancer Control and Prevention Program, Institut this project and Xavier Escalada, senior researcher at 061 CatSalut Respon, for Català d’Oncologia-ICO, Av. Granvia de L’Hospitalet 199-203, L’Hospitalet de his counseling and support during the design of the project. Finally, they Llobregat, 08908 Barcelona, Spain. 2Cancer Control and Prevention Group, also want to thank Marta Enriquez for her valued work during the fieldwork Institut d’Investigació Biomèdica de Bellvitge-IDIBELL, Av. Granvia de contributing to recruiting patients and giving support to the research group. L’Hospitalet 199-203, L’Hospitalet de Llobregat, 08908 Barcelona, Spain. 3 Addictions Unit, Institute of Neurosciences, Hospital Clínic de Barcelona, C. Funding Villarroel 170, 08036 Barcelona, Spain. 4Medicine and Health Sciences School, This study has been funded by the Instituto Carlos III (ISCIII) (Grant: PI15/ Universitat Internacional de Catalunya, C. Josep Trueta s/n, 08915 Sant Cugat 00875) Fondo Europeo de Desarrollo Regional (FEDER) “Una manera de del Valles, Barcelona, Spain. 5Department of Clinical Sciences, School of hacer Europa”. Medicine, Universitat de Barcelona, C. Feixa Llarga s/n, L’Hospitalet del Llobregat, 08907 Barcelona, Spain. 6061 CatSalut Respon, Sistema Availability of data and materials d’Emergències Mèdiques, C. Pablo Iglesias 115, L’Hospitalet de Llobregat, The datasets generated and/or analyzed during the current study will be 08908 Barcelona, Spain. 7Smoking Cessation Unit, Addictive Behaviors Unit, available from the corresponding author on reasonable request. Psychiatry Department, Hospital Universitari Vall d’Hebron, Vall d’Hebron A computer-specific application for the study will be designed for data re- Institute of Research, CIBERSAM, Universitat Autònoma de Barcelona, Passeig cording and management, including randomization. The software will be de la Vall d’Hebron 119-129, 08035 Barcelona, Spain. 8Addictive Behaviors created following the current standards of security, privacy, and confidential- Unit, Psychiatry Department, Hospital de la Santa Creu i Sant Pau, C. San ity. All study researchers will have access to the application using a personal Antoni Ma Claret 167, 08025 Barcelona, Spain. 9Mental Health Department, username and password. Clinicians from each center will only be able to Althaia Xarxa Assistencial Universitària, C. Dr. Llatjós s/n, Manresa, 08243 register and have access to review information from patients from their own Barcelona, Spain. 10Alcohol Program, Psychiatry Department, Hospital center. Universitari de Bellvitge, Institut Català d’Oncologia, IDIBELL, CIBERSAM, Feixa Once the study is completed, researchers from the hospitals and 061 Llarga s/n, L’Hospitalet de Llobregat, 08907 Barcelona, Spain. 11Psychiatry CatSalut Respon professionals will no longer have access to the database. Department, Hestia Duran i Reynals, Av. Granvia de L’Hospitalet 199-203, The ICO is responsible for properly saving the files, and its protection by L’Hospitalet de Llobregat, 08908 Barcelona, Spain. 12Institut d’Investigació encrypted secure systems, until its eventual destruction (5 years after study Biomèdica Sant Pau, C. San Antoni Mª Claret 167, 08025 Barcelona, Spain. 13 completion). The database will not identify patients in any way, creating an Lleida Institute for Biomedical Research Dr. Pifarré Foundation, IRBLleida, individual encrypted code. Data collected during the study will be included Universitat de Lleida, Av. Alcalde Rovira Roure, 80, 25198 Lleida, Spain. 14 in a file registered by the Spanish Data Protection Agency. Public Health Agency of Catalonia, Health Department, Government of Catalonia, C. Roc Boronat 81-95, 08005 Barcelona, Spain. 15Philip R. Lee Authors’ contributions Institute for Health Policy Studies, University of California San Francisco, 3333 MB and CM are the principal investigators (PIs) and are responsible for California St., Ste. 265, San Francisco, CA 94118, USA. conducting the trial, looking after adherence to the protocol, and clinical treatment supervision. AF is the researcher assistant of the study and has Received: 4 December 2017 Accepted: 5 December 2018 collaborated to the coordination of the study. EF is co-IP and senior re- searcher who will provide expert advice to the PIs. The PIs and the co-IP will have ultimate authority over any of the activities related to this research and the final decision to submit the report for publication. The clinical researchers References (GN, EB, JV, SS, PB, SM, SC, CP, RH-R) will be responsible for recruiting the pa- 1. Secades-Villa R, Olfson M, Okuda M, Velasquez N, Perez-Fuentes G, Liu S-M, tients. 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