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In Sweden, the prevalence of tobacco use is disproportionately high among socioeconomically disadvantaged groups. Previous research and clinical experience suggest that prescribed lifestyle interventions in the primary health care (PHC) setting such as Physical Activity on Prescription are effective in changing behavior. However, there is a lack of evidence for if and how such a prescription approach could be effectively transferred into the tobacco cessation context.
The aim of this trial is to evaluate the effectiveness and cost-effectiveness of Tobacco Cessation on Prescription (TCP) compared to current practice for tobacco cessation targeting socioeconomically disadvantaged groups in the PHC setting in Sweden.
The design is a pragmatic cluster-randomized controlled trial. The sample will consist of 928 daily tobacco users with Swedish social security numbers and permanent resident permits, recruited from 14-20 PHC centers located in socioeconomically disadvantaged areas in Stockholm County. The primary outcome will be measured in self-reported 7-day abstinence at 6 and 12 months after the intervention. The secondary outcomes will be measured in daily tobacco consumption, number of quit attempts, and health-related quality of life at 6 and 12 months after the intervention. Data will be collected through questionnaires and review of electronic medical records. Cost-effectiveness will be estimated through decision analytic modeling and measured by the incremental cost per quality-adjusted life year.
In the first set of PHC centers participating in the study, eight centers have been included. Recruitment of individual study participants is currently ongoing. Inclusion of a second set of PHC centers is ongoing with expected study start in September 2016.
If TCP is found effective and cost-effective compared to standard treatment, the method could be implemented to facilitate tobacco cessation for socioeconomically disadvantaged groups in the PHC setting in Sweden.
International Standard Randomized Controlled Trial Number (ISRCTN): 11498135; http://www.isrctn.com/ISRCTN11498135 (Archived by WebCite at http://www.webcitation.org/6kTu6giYQ)
Smoking is a major risk factor for more than 60 different diseases, out of which cardiovascular diseases, lung diseases and cancers are the most common [
Since tobacco cessation has been found to reduce the risk of premature morbidity and mortality caused by tobacco-related diseases [
Studies conducted on health care consumption in Stockholm in different social groups show that individuals with foreign background, low educational level and low income visit primary health care (PHC) more often than their counterparts [
In a recent study, the perceived feasibility and optimal design of Tobacco Cessation on Prescription (TCP) as a PHC intervention targeting disadvantaged groups in Sweden, was explored [
In order to evaluate the effectiveness and cost-effectiveness of the intervention, a two-armed pragmatic cluster-randomized controlled trial [
Flow chart of the study design.
Study participants will be recruited from participating PHC centers located in socioeconomically disadvantaged areas in Stockholm County, Sweden. Eligible PHC centers will be identified based on a socioeconomic index, which takes into account the income, educational level, ethnicity and health status of the population in a PHC center’s catchment area [
PHC centers located in areas with low socioeconomic status in Stockholm County will be identified through the previously mentioned socioeconomic index [
Study participants will be recruited by one to three appointed providers employed at each of the participating PHC centers. However, all staff at the participating PHC centers will be able to refer patients to recruiting staff for more information about the study. In order to reduce selection bias, eligible participants will be identified through a short screening questionnaire before being invited to participate. Further information about the study will be administered by the recruiting staff at the participating PHC centers and written informed consent to participate sought before invited participants will be included in the study. Staff responsible for the recruitment of study participants will receive a brief training in the study design and recruitment procedure before the study start. Recruiting staff will also receive posters to help facilitate the recruitment of individual study participants. The recruitment period is expected to last for 18 to 24 months.
The TCP method is based on the PAP concept, which consists of person-centered counseling on physical activity, individualized prescription of physical activity, co-operation between prescribers and providers of physical activity, follow-up of the prescription, and a comprehensive manual that describes for which indications and how the method should be used [
Prior to the administration of the intervention, one to three PHC providers per center, responsible for the treatment of patients in the intervention group, will receive 4 hours of training by representatives from the Swedish National Tobacco Quitline (SNTQ) [
The core components of the intervention consist of tobacco cessation counseling of tobacco users according to the TCP method. This is defined as tobacco cessation counseling (minimum 10 minutes) provided by a qualified health care professional in combination with a prescription for individualized tobacco cessation treatment, including options for (1) further counseling (referral to a health care provider with more competence or SNTQ), (2) pharmacotherapy (nicotine replacement therapy, varenicline, bupropion), (3) other measures for tobacco cessation (physical activity and other strategies to cope with withdrawal symptoms), (4) follow-up (by telephone or revisit) and (5) support for self-management (questions for self-reflection, reference to mobile applications, Web-based counseling and websites for more information and support). The approach will be individualized in the sense that providers will discuss the available treatment options, contraindications, preferences, and other relevant circumstances with the patient and then decide together which treatment alternative(s) suit the individual best. The TCP method also includes follow-up of the prescription by the prescriber on at least one occasion.
Standard treatment is defined as treatment for tobacco cessation according to current practices at the PHC center. Since the choice of tobacco cessation treatment varies depending on individual characteristics and preferences of tobacco users and it is up to each PHC center to decide for themselves how their tobacco cessation services should be organized, the treatment components (eg, type of counseling and pharmacotherapy) are expected to vary both within and between the study arms. Thus, the provided treatments will be documented by one to three PHC providers per center in the control group responsible for the treatment of study participants and further defined retrospectively. Since the same treatment components are likely to be present in both study arms, it is important to state that the major difference between them is how the counseling is administered (with or without a prescription form). The minimum intervention for the control group is a brief advice (<5 minutes).
To ensure that the difference between the trial conditions is dependent on the prescription form and not on the training of PHC staff, the PHC providers responsible for the treatment of patients in the control group will receive 3.5 hours of training by representatives from SNTQ and the County Council in available treatment options for tobacco cessation prior to the study start (the same training as the intervention group, excluding the 30 minute TCP component). A manual identical to the one developed for the intervention group, excluding all information about the TCP method and summarizing the training, has been developed and will be distributed in connection with the education of PHC providers in the control group.
Conceptual model for TCP.
The primary outcome of the intervention will be measured in self-reported point prevalence of 7-day abstinence (total abstinence from tobacco use during the 7 days preceding follow-up) at 6 months after the intervention. The secondary outcomes are self-reported point prevalence of 7-day abstinence at 12 months after the intervention and 3-month continued abstinence, daily tobacco consumption (number of cigarettes), number of quit attempts (periods of total abstinence from tobacco use for more than 24 hours) and health-related quality of life (on a scale from 0-1 where 0 represents death and 1 represents perfect health) at 6 and 12 months after the intervention. All outcomes will be based on patients' self-reports. Cost-effectiveness will be measured as the incremental cost per quality-adjusted life year.
Data on sociodemographic characteristics, tobacco use, and nicotine dependence, previous quit attempts, self-efficacy and motivation to quit, health status and health-related quality of life will be collected through patient questionnaires. The questionnaires are based on questions from the Swedish Public Health Survey 2014 [
The measurements will be conducted at baseline (before the intervention) and 6 and 12 months after the intervention. In the follow-up questionnaires, questions regarding the tobacco cessation-related care the patients have received during the study period have been added. The baseline questionnaires will be administered by staff responsible for the treatment of patients at the participating PHC centers. The PHC providers administering the treatment will also document what treatment the patients have received (duration, content, intensity and number of visits, mode of counseling, referrals, any recommended and prescribed pharmacotherapy, follow-ups, etc) in the electronic medical records and in study specific documentation protocols. Staff will be educated in the documentation procedures before the start of the study. The follow-up questionnaires will be sent to the participants via mail by the researchers to avoid attrition caused by additional costs and administrative burden of revisits for the study participants. A reminder with a new follow-up questionnaire attached will be sent out via mail by the researchers if the follow-up questionnaire is not returned within ten days. If the reminder questionnaire is not returned, additional reminders to return the questionnaire will be sent out via mail, email and SMS text messaging (short message service, SMS) by the researchers. In connection with the second reminder, the participants will be offered the opportunity to answer the questionnaire in a telephone interview. Multiple reminders and forms of contact have been found essential in promoting high retention rates among disadvantaged research participants who are often highly mobile [
Additional data on the characteristics of participating PHC centers and providers delivering the intervention will be collected through questionnaires and interviews. This includes data on organizational aspects such as number of listed patients, number of employees, and type of professions and routines for tobacco cessation at the PHC center level and data on age, sex, profession, qualifications, and personal experiences of tobacco use and tobacco cessation at the PHC provider level. Data on structural changes in the PHC centers during the study period (eg, staff turnover) will also be collected retrospectively. This data will be collected by the researchers.
The required sample size was calculated based on the primary outcome, assuming a 7% rate of 7-day prevalence in abstinence from tobacco use at 6 months follow-up in the control group, significance level of 5% and 80% power to detect a 2.0 relative risk of successful quit attempts in the intervention group compared to the control group. The estimated prevalence of abstinence in the control group corresponds to the success rate of brief advice [
A computer generated random allocation sequence will be applied to randomize the PHC centers to either intervention or control conditions with a 1:1 ratio. Cluster-randomization will be employed at the PHC center level, meaning that all individual study participants recruited from a particular PHC center will receive the same treatment. This will be done due to feasibility reasons and to avoid contamination of the trial conditions. The PHC centers will be paired based on their socioeconomic index and allocated to the treatment conditions from each pair after they have agreed to participate, approximately one month before the PHC provider training. Each set of participating PHC centers will be randomized separately. The randomizations will be conducted by a statistician.
The PHC providers and study participants will not be blinded. However, the study participants will not be informed about the difference between the trial conditions until after the study. This will be done in order to avoid attrition and preconceptions regarding the treatment effectiveness that could affect the study results (risk that study participants in the control group could perceive standard treatment as less effective compared to TCP).
In order to describe the setting and the effectiveness of the randomization, descriptive statistics of the study population’s baseline characteristics at both individual and cluster level will be presented separately for the intervention and control arm, as proportions for categorical variables and as mean values with corresponding standard deviation (SD) for continuous variables.
The association between the treatment and the outcomes post-intervention will be analyzed using multiple regression models. A logistic regression model will be used for binary outcomes, including the primary outcome, 7-day abstinence. The result will be presented as an odds ratio (OR) and corresponding 95% confidence interval (CI). The association between the treatment and continuous/count outcomes, including the secondary outcomes, daily tobacco consumption, number of quit attempts and health-related quality of life, will be analyzed using multiple linear and Poisson regression models. All analyses will be conducted according to the intention to treat principle [
A process evaluation will be conducted to measure implementation outcomes such as service delivery of tobacco cessation at the PHC center level and self-reported fidelity to the intervention at the PHC provider level and the participant level [
A health economic evaluation will be conducted alongside the trial to evaluate the cost-effectiveness of the intervention compared to standard treatment. This will be done by incorporating the trial results on effectiveness and data from other sources into a decision analytic model specifically developed to estimate the future costs and outcomes of tobacco cessation interventions. Decision analytic models are often used in health economic evaluations since they allow for synthesis of data from different sources and extrapolation of events beyond a clinical trial [
From April to November 2015, eight PHC centers were recruited and randomly assigned to the trial conditions. The PHC providers responsible for the treatment of study participants were trained in February and April 2016. Recruitment of individual study participants is currently ongoing. Recruitment of a second set of PHC centers is also ongoing. The expected study start of the second set of PHC centers is in September 2016.
This study aims to evaluate the effectiveness and cost-effectiveness of a novel intervention that builds on previous research and experiences of prescribed lifestyle interventions in the PHC setting in Sweden that could potentially facilitate a more structured approach to tobacco cessation for socioeconomically disadvantaged groups compared to current practice. The method is based on clinical guidelines for tobacco cessation treatment in the Swedish health care setting [
A key concern when conducting the study is reaching the intended target population. For example, language barriers may limit the access to the most disadvantaged groups. However, the two most common languages in the target population, Swedish and Arabic, are considered in the study. It is important that the participating PHC centers have access to interpretation services, or staff fluent in these languages, and that the materials are available in both languages to enable recruitment of participants and delivery of the intervention as intended [
A possible limitation of the study is due to self-reported tobacco-related outcomes. The accuracy of self-reported tobacco use tends to be lower compared to biochemical markers such as cotinine measurements and may lead to underestimates of tobacco use due to underreporting as a consequence of social desirability [
Another potential limitation is that the education of PHC providers is relatively brief (4 hours). However, data collected at the PHC center level prior to the study start showed that the majority of the PHC providers responsible for the treatment of patients had previous training in tobacco cessation treatment, motivational interviewing or lifestyle counseling. Given this fact, the length of the education was considered sufficient by the participating PHC centers and the representatives from SNTQ and the County Council that were involved in designing the training of the PHC providers in the study.
A major strength of the study is the robustness of its design. The pragmatic approach will provide high external validity under real world conditions in the context under study [
Physical Activity on Prescription
primary health care
Swedish National Tobacco Quitline
Tobacco Cessation on Prescription
The study is funded by grants from the Stockholm County Council (grant no: HSN 1309-1029), The Public Health Agency of Sweden (grant no: 03074-2015-6.2) and Livförsäkringsbolaget Skandia. The views expressed are those of the authors and not necessarily those of the funding agencies. The authors would like to thank Ann Post, Lena Lundh, Rosaria Galanti, and Solvig Ekblad for their valuable comments on the study protocol and materials.
TT conceived the study and led procurement of funding assisted by AL. AL drafted study protocol supervised by TT with assistance by PL, CJS and MP. The latter provided statistical expertise. AL wrote first draft of study protocol manuscript, all provided input. All authors have read and approved the final manuscript.
None declared.