Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study): study protocol for a randomized controlled trial

Health effects among smokers and non-smokers of tobacco consumption are well-established including principally respiratory and cardiovascular diseases and cancer [1]; in fact is one of the leading preventable causes of death worldwide and mainly in occidental societies [2]. In Spain, for instance, smoking is the health problem that causes more mortality and morbidity [3], and therefore originates one of the higher health costs. According to the last national survey conducted in Spain in 2006 the percentage of daily smokers aged 16 or older was 26.44% [4]. The vast majority of smokers declare a willingness to quit smoking and approximately 60% have tried it [3], although only 3 to 5% of them per year accomplished smoking cessation [3, 5, 6].

Several cost-effectiveness studies worldwide have shown that both low and high impact care interventions to reduce tobacco consumption are cost-effective measured in cost per year of life gained and quality of life [3, 7]. Moreover, under a public health view probably these interventions represent the most cost-effective method to improve population’s health. Minimum advice on quitting smoking among the general population achieves an average of 5% cessation per year [8, 9]. In contrast, more intense interventions, can reach more than 20% of abstinence [10, 11]; in general, it is well established that the more intensive the intervention, the best rates of smoking cessation are obtained [10]. The inclusion of those treatments that have demonstrated its efficacy in systematic reviews and metanalysis, has been confirmed to be useful [7].

Therapeutic intensive interventions for smoking cessation have been used in primary care, such as the one of the ISTAPS study [12], but none have been based in Information and Communication Technologies (ICTs). These interventions are based on the hypothesis that smokers that do not quit smoking but are aware of its harmful effects underestimate the health risk to due to its consumption [13]. So, these interventions could provide motivational feedback to promote risk awareness and accelerate changes on smoking behavior [14]. Some smokers who quit smoking have been identified as susceptible to damaging adverse effects of tobacco consumption or seen seriously threaten his or her health [15, 16].

The vast majority of non-pharmacological use the Prochaska and DiClemente’s Transtheoretical Model of Change [17] that describes a succession of stages (precontemplation, contemplation, preparation, action and maintenance) each one indicating a different type of intervention. Other studies in our country have used this model among diabetic smokers patients attended in primary care and to confirm smoking abstinence using cooximetry [18] and another where information gathered by cooximetry is the main element to motivate smokers to quit [19].

The use of electronic mail and internet is increasing worldwide. In Spain, according to the National Statistics Institute, in 2010, 57% of households had Internet access; moreover there are 20 million estimated regular users and those who log at least once a week represent 58.4% of the population (7.1% increase over the previous year). Seventy-eight percent of the Spanish population between 16 and 74 uses the electronic mail, with an increase of those who access it via mobile devices [20].

Internet and E-mail use is also increasing in medicine and can be mostly useful in appointment citations and remainders, analytical results, computerized medical history, prescription refills, regular follow-up and access to health information. The advantages derived from professional-patient E-mail communication include: time and cost saving for hospitals, primary care centers, primary care professionals and patients (e.g. patients who frequently travel and sanitary professional of rural areas can easily contact with physicians and patients respectively) [21, 22] and convenience since it does not have a simultaneous nature (the person can check the messages at his or her convenience) [21]. Several patients also refer that E-mail communication can facilitate the contact with the sanitary professional; in face to face interviews they could not feel enough comfortable to rise certain issues or may have forgotten to ask important questions. Some of them deem a useful and satisfactory use E-mail communication in a secure and private environment [21]. A revision undertaken on the impact of e-therapies, Hsiung concluded that E-mail tracking is useful if preceded by a personal and direct relationship with the patient [23]. Finally, in the global crisis context these types of interventions can diminish visits to the primary care center. Limitations comprise unwillingness to use the E-mail, perception of lack of time and experience to use the new technologies [21, 24], an abuse by an overriding number of messages on non urgent matters, and the development of a private and secure website and a specific deontological code could increase the economic costs [25].

Internet use in quitting smoking is becoming more evident, since it is necessary to recruit more smokers to fight smoking regardless of race or culture [26]. Several studies have published about the virtual communities in this field [27] and internet as a support to phone lines (quitlines) [28]. It has been established that it is a way that enriches the sanitary professional-patient relationship and that the dissemination of patient’s successful experiences can improve their self-esteem and generate positive attitudes [25] although further research is needed [29].

The 2008 the Treating Tobacco Use and Dependence Guideline, pointed out that online tools to quit smoking are promising tools that have not achieved its own potential to undertake interventions; results have been shown to be only favorable if online interventions are developed in very complex programs or if were carried out when the help was more intensive among intervention groups than in controls. Nevertheless, it also encourages depending on those characteristics that needs to be improved [7]. In Spain, the National Committee to Prevent Smoking Cessation (CNPT in Spanish) also supports these types of interventions to help smokers to quit [3].

Characteristics of smokers who seek help on the Internet to quit smoking were female sex (59%) and younger individuals. Generally are subjects who are trying to quit smoking (53%) and search information on how or medication to quit, whilst those who have already quit search information on how to face abstinence [30].

Twenty studies have been found to be registered at Clinical Trial when using keywords: E-mail AND smoking, none undertaken in Primary Care environment with personalized follow-up (Clinical Trials, 2012). In 2010 the Cochrane library published a revision that included the most relevant articles on internet interventions for quitting smoking. Ten out of twenty compared an internet based intervention with others not based on this media. The revision concluded that personalized and interactive internet based interventions, especially if there is an individualized tracking, can be more effective than those standardized protocols on smoking cessation. However, long-term smoking cessation is less effective when using these interventions compared to other interventions [31].

Te Poel and collaborators published in 2009 a clinical essay to evaluate the efficacy of an E-mail computer-tailored smoking cessation intervention. At six months post intervention 21.5% and 20.4% of intervention group reported not having smoked in the last 24 hours and in the 7 days, respectively compared to the control group (9.8 and 7.8%, respectively); follow-up lost were quite high in both control and intervention groups [32]. Polosa et al. demonstrated the utility of an E-mail consultation messages in a smoking-cessation program although the number of included patients was somewhat low [33]. Lenert and collaborators determined the effectiveness of an automated educational E-mail messaging system individually sent in the framework of smoking cessation intervention. The OR for quitting smoking among the intervention group at 30 days post-intervention was 2.6 (95% CI: 1.3-5.3) [34]. An increased smoking and reduced frequency of smoking was observed in young adults after an online peer support via E-mail [35] and in adolescents after a home based internet intervention [36, 37].

In Spain there are two online initiatives to help smokers to quit. The first one, the Madrid City Council Giving-up smoking on-line Programme, that combined automated interaction with the user and personal E-mail consultations that included 4865 smokers. After the treatment period the smoking cessation rate was 17.8% and at six months post intervention the abstinence achieved was 10% [38]. The second one is undertaken by the Psychology Faculty of the National Distance Education University (UNED) but not results have been published yet [39].

In Barcelona, Spain, the study E-consulta in Primary Care setting is being undertaken. Its main objective is to develop a secure web environment for sanitary professional-patient communication via E-mail (e.g. acute health problems, laboratory results, health measurement reports, or prescription refills) to avoid unnecessary face to face visits. The sanitary professional committed to answer patients E-mail on the following 48 working hours. The study is carried out in twelve primary care centers and includes 19 physicians, 16 nurses and 647 patients. This initiative has been positively evaluated by both sanitary professionals and patients and it is planned to spread it to all territorial setting [40].

Both, The E-consulta and the experience described by Wallwiener and collaborators in 2009 [22, 40], allow to think that better service and satisfaction of primary care services will be achieved by reducing resources of primary care addressed to smoking cessation. If sanitary systems facilitated E-mail based interventions on smoking cessation, and other sanitary problems, costs could be reduced and medical care and patient and sanitary professional satisfaction could be improved.

The proposed intense intervention consists in the application of the recommendations of an evidence-based practical clinical guideline of the Primary Care Division of the Catalan Institute of Health [42] based in six contacts (two face to face interviews and 4 E-mails), to obtain continued smoking abstinence at 6 and 12 months. There are some international studies that use E-mail based interventions to help smokers to quit, but none has the same characteristics as the one proposed [5, 10, 26, 27, 32–35, 37, 49]. Furthermore, to our best knowledge, in Spain there are no studies that use this type of interventions at any level of clinical services.

Since the implementation in 2006 of the law 28/2006 for smoking prevention, the number of primary care consultations regarding smoking cessation has been raised, subsequently an approach to smoking cessation should be a key essential objective of both the clinical practice and public health research. Subsequently, primary care is an ideal setting to develop a health counseling E-mail program based on a practical clinical guideline due to its almost universal coverage in Spain [3, 50]; it is estimated that 75% of the population visits his or her general practitioner at least once a year, and that people who smoke do so more often than non-smokers [3, 51].

One of the main strengths of the TABATIC project is that, to our best knowledge, for the first time the therapeutic use of E-mail tracking will be evaluated in order to help smokers to quit. Furthermore, the same sanitary professional, who habitually attends the patient and with whom a previous confidence relationship has been established, is the one who follows the patient during this intervention which can lead to more successful outcomes if compared to other more impersonal follow-up interventions such as web pages or community programs [31]. Another strength of E-mail tracking interventions according to Kuppersmith is its asynchronous nature; E-mail communication allows physician and patient not to be available at the same time. In addition, both can access at their messages at their own convenience and as many times as needed [21]. Moreover, this type of intervention could reduce social and sanitary costs due to its great accessibility, its capability to diminish trips and timeouts to be attended.

Selection bias among health care professionals may occur since those who volunteered to participate could be more motivated than other sanitary professionals. Randomization will be made among smokers and not in primary care centers which will lead to use this E-mail intervention in only some of his or her patients; however the randomization will be previously automatically created so the professional will not be able to decide on which patients should use the intervention since it will be computer generated. Patients assigned to the control group will receive a brief advice on quitting smoking. One of the main limitations of the study is that we will only include professionals who know how to use computers and E-mail and can assure participation in the study by using it. However we feel confident that an important number of participating professionals will run correctly the program since most of them have previously participated in other complex tobacco studies undertaken in our territory such as the ISTAPS (176 basic care units that worked in 82 Spanish primary care centers; participants: 2,827 smokers aged 14–85 years), ITADI (400 professionals and 1077 diabetic smokers) and BIBE studies (162 pediatric teams from 96 Spanish primary care centers; participants: 1101 child) [12, 18, 52]. No economic compensation will be offered to sanitary professionals; consequently, those who expect to be reimbursed for this extra activity will be also excluded of the study. Some professionals may be reluctant to use electronic mail in professional health care-patient communication. Reasons to be reluctant may include the believe that written messages can omit important connotations in communication (such as body language or voice tone), the concern that individuals may send a vast number of irrelevant messages and the possible dissemination of health professional e-mail address [21, 53]. To assure health care professional and patient confidentiality, an external company will develop and maintain the study a secure web page; if needed, they will control and limit each subject web page use [54]. We are currently carrying out a qualitative study in order to describe possible barriers and facilitators of Information and Communication and Technologies to help smokers to quit.

If the proposed intervention is effective, it should be adapted to the informatics systems of each local health service.

The present trial aims to show the effectiveness of an E-mail smoking cessation intervention based in the recommendations of an evidence-based clinical practice guideline of the Primary Care Division of the Catalan Institute of Health at six and twelve months post-intervention [42]. The goal is to propose a new and effective intervention in primary care, as well as in other sanitary settings, as a complementary tool to treat smokers.