The prognostic value of quality of life in atrial fibrillation on patient value.

BACKGROUND: In this study, the prognostic value of AF-related quality of life (AFEQT) at baseline on Major Adverse Cardiovascular Events (MACE) and improvement of perceived symptoms (EHRA) was assessed. Furthermore, the relationship between QoL and AF-related hospitalizations was assessed. METHODS: A cohort of AF-patients diagnosed between November 2014 and October 2019 in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. MACE was defined as stroke, myocardial infarction, heart failure and/or mortality. Subsequently, MACE, EHRA score improvement and AF-related hospitalizations between baseline and 12 months of follow-up were recorded. RESULTS: In total, 970 AF-patients were available for analysis. In analyses with patients with complete information on the confounder subset 36/687 (5.2%) AF-patients developed MACE, 190/432 (44.0%) improved in EHRA score and 189/510(37.1%) were hospitalized during 12 months of follow-up. Patients with a low AFEQT score at baseline more often developed MACE (OR(95%CI): 2.42(1.16-5.06)), more often improved in EHRA score (OR(95%CI): 4.55(2.45-8.44) and were more often hospitalized (OR(95%CI): 4.04(2.22-7.01)) during 12 months post diagnosis, compared to patients with a high AFEQT score at baseline. CONCLUSIONS: AF-patients with a lower quality of life at diagnosis more often develop MACE, more often improve on their symptoms and also were more often hospitalized, compared to AF-patients with a higher quality of life. This study highlights that the integration of patient-reported outcomes, such as quality of life, has the potential to be used as a prognostic indicator of the expected disease course for AF.

Facilitating and Inhibiting Factors in the Design, Implementation, and Applicability of Value-Based Payment Models: A Systematic Literature Review.

Evidence on the potential for value-based payment models to improve quality of care and ensure more efficient outcomes is limited and mixed. We aim to identify the factors that enhance or inhibit the design, implementation, and application of these models through a systematic literature review. We used the PRISMA guidelines. The facilitating and inhibiting factors were divided into subcategories according to a theoretical framework. We included 143 publications, each reporting multiple factors. Facilitators on objectives and strategies, such as realistic/achievable targets, are reported in 56 studies. Barriers regarding dedicated time and resources (e.g., an excessive amount of time for improvements to manifest) are reported in 25 studies. Consensus within the network regarding objectives and strategies, trust, and good coordination is essential. Health care staff needs to be kept motivated, well-informed, and actively involved. In addition, stakeholders should manage expectations regarding when results are expected to be achieved.

The Impact of Value-Based Payment Models for Networks of Care and Transmural Care: A Systematic Literature Review.

INTRODUCTION: Value-based healthcare has potential for cost control and quality improvement. To assess this, we review the evidence on the impact of value-based payment (VBP) models in the context of networks of care (NOC) and transmural care. METHODS: We used the PRISMA guidelines for this systematic literature review. We searched eight databases in July 2021. Subsequently, we conducted title and abstract and full-text screenings, and extracted information in an extraction matrix. Based on this, we assessed the evidence on the effects of VBP models on clinical outcomes, patient-reported outcomes/experiences, organization-related outcomes/experiences, and costs. Additionally, we reviewed the facilitating and inhibiting factors per VBP model. FINDINGS: Among articles studying shared savings and pay-for-performance models, most outline positive effects on both clinical and cost outcomes, such as preventable hospitalizations and total expenditures, respectively. Most studies show no change in patient satisfaction and access to care when adopting VBP models. Providers' opinions towards the models are frequently negative. Transparency and communication among involved stakeholders are found to be key facilitating factors, transversal to all models. Additionally, a lack of trust is an inhibitor found in all VBP models, together with inadequate targets and insufficient incentives. In bundled payment and pay-for-performance models, complexity in the structure of the program and lack of experience in implementing required mechanisms are key inhibitors. CONCLUSIONS: The overall positive effect on clinical and cost outcomes validates the success of VBP models. The mostly negative effects on organization-reported outcomes/experiences are corroborated by findings regarding providers' lack of awareness, trust, and engagement with the model. This may be justified by their exclusion from the design of the models, decreasing their sense of ownership and, therefore, motivation. Incentives, targets, benchmarks, and quality measures, if adequately designed, seem to be important facilitators, and if lacking or inadequate, they are key inhibitors. These are prominent facilitators and inhibitors for P4P and shared savings models but not as prominent for bundled payments. The complexity of the scheme and lack of experience are prominent inhibitors in all VBP models, since all require changes in several areas, such as behavioral, process, and infrastructure.

Age-dependency of EHRA improvement based on quality of life at diagnosis of atrial fibrillation.

BACKGROUND: In this study, the relationship between AF-related quality of life (AFEQT) at baseline in AF-patients and the improvement on perceived symptoms and general state of health (EHRA, European Heart Rhythm Association score) at 12 months was assessed across predefined age categories. METHODS: Between November 2014 and October 2019 patients diagnosed with AF de novo in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. These AF-patients were categorized into quartiles based on their AFEQT score at diagnosis and EHRA score was measured at diagnosis and 12 months of follow-up. Stratified analyses were performed using age categories (<65 vs. ≥65 years; <75 vs. ≥75 years). RESULTS: In total, 203/483 (42.0%) AF-patients improved in EHRA score after 12 months of follow-up. AF-patients in the lowest AFEQT quartile were more likely to improve, compared to patients in the highest AFEQT quartile (OR [95%CI]:4.73 [2.63-8.50]). Furthermore, patients ≥65 years and patients <75 years at diagnosis with lower AFEQT scores at baseline were most likely to improve in EHRA score after 12 months, compared to similarly aged patients with higher AFEQT scores at baseline. CONCLUSION: The present study indicates that AF-patients with a lower quality of life at diagnosis were most likely to improve their EHRA score after 12 months. This effect was most prominent in patients ≥65 years of age and patients <75 years of age, compared to patients >65 and ≥75 years, respectively. Future research should focus on further defining characteristics of these age groups to enable the implementation of age-tailored treatment.

Regional implementation of atrial fibrillation screening: benefits and pitfalls.

Aims: Despite general awareness that screening for atrial fibrillation (AF) could reduce health hazards, large-scale implementation is lagging behind technological developments. As the successful implementation of a screening programme remains challenging, this study aims to identify facilitating and inhibiting factors from healthcare providers' perspectives. Methods and results: A mixed-methods approach was used to gather data among practice nurses in primary care in the southern region of the Netherlands to evaluate the implementation of an ongoing single-lead electrocardiogram (ECG)-based AF screening programme. Potential facilitating and inhibiting factors were evaluated using online questionnaires (N = 74/75%) and 14 (of 24) semi-structured in-depth interviews (58.3%). All analyses were performed using SPSS 26.0. In total, 16 682 screenings were performed on an eligible population of 64 000, and 100 new AF cases were detected. Facilitating factors included 'receiving clear instructions' (mean ± SD; 4.12 ± 1.05), 'easy use of the ECG-based device' (4.58 ± 0.68), and 'patient satisfaction' (4.22 ± 0.65). Inhibiting factors were 'time availability' (3.20 ± 1.10), 'insufficient feedback to the practice nurse' (2.15 ± 0.89), 'absence of coordination' (54%), and the 'lack of fitting policy' (32%). Conclusion: Large-scale regional implementation of an AF screening programme in primary care resulted in a low participation of all eligible patients. Based on the perceived barriers by healthcare providers, future AF screening programmes should create preconditions to fit the intervention into daily routines, appointing an overall project lead and a General Practitioner (GP) as a coordinator within every GP practice.

Successful implementation of ehealth interventions in healthcare: Development of an ehealth implementation guideline.

INTRODUCTION: eHealth interventions have the potential to improve the quality of healthcare and reduce costs. However, to implement eHealth interventions successfully instruments are needed to facilitate this process. This study aims to develop an eHealth implementation guideline for implementation of eHealth interventions in daily practice. METHODS: In June and July 2019 a literature research was conducted and, subsequently, a two-round Delphi study including 13 international eHealth experts in the field of healthcare, ICT & technology, and research was performed. Within the Delphi study, experts scored specific determinants using an online survey. Based on mean scores and interquartile ranges (IQRs) in the online survey, consensus between the experts was assessed. RESULTS: A total of five domains (i.e., Technology, Acceptance, Financing, Organizational, and Legislation & Policy) with 24 corresponding determinants were assessed by the experts. After the second Delphi round, consensus was achieved on the five domains and 23 determinants (mean scores ≥ 8; IQR ≤ 2). Only for the determinant 'Evidence-Based Medicine' was no consensus reached (mean score < 8; IQR = 2). Based on the 23 determinants, the eHealth implementation guideline is developed for eHealth implementations in healthcare in order to increase their effectiveness. CONCLUSION: The eHealth implementation guideline developed in this study may help healthcare providers/researchers assess the determinants of successful eHealth intervention prior to the implementation of the eHealth program.

Regional collaboration to improve atrial fibrillation care: Preliminary data from the Netherlands heart network.

BACKGROUND: Guideline non-adherence and variations in therapeutic and diagnostic trajectories result in suboptimal atrial fibrillation (AF) treatments. Large academic and referral hospitals demonstrated positive effects of dedicated outpatient AF clinics. Although similar results have not been indicated in (small) non-academic hospitals yet, ample opportunities are present when collaboration is initiated on a regional level. Therefore, this study assesses the effectiveness of outpatient AF clinics in a collaborative region in the Netherlands. METHODS: For this study baseline and 6 months follow-up data of a prospective cohort including newly or recently diagnosed AF-patients of 4 hospitals involved in the Netherlands Heart Network are used. From January'15 to March'16 patient relevant outcome measures (ie EHRA score, stroke, major bleedings, hospitalizations, serious adverse effects of medication, and mortality) are gathered. Descriptive and regression analyses are performed to assess the effectiveness of outpatient AF clinics. RESULTS: In the analyses 448 AF-patients were included. After 6 months, significant improvements regarding EHRA score (P < 0.01), hypertension (P < 0.01), and type of AF (P < 0.01) were indicated. Results of the patient relevant outcomes showed that AF-patients were hospitalized 23 times, no major bleedings and 2 strokes occurred. Furthermore, 0 AF-patients reported serious adverse effects of medication and no AF-patients deceased. CONCLUSIONS: Collaboration between cardiologists in a regional setting permits further improvement of AF care. Therefore, such quality targets are not exclusively reserved to large academic or referral hospitals. Although promising, future research should put effort in measuring the effectiveness of the outpatient AF clinics also on the long run.

Differences in Sociocognitive Beliefs between Involved and Noninvolved Employees during the Implementation of an Electronic Health Record System.

BACKGROUND: Electronic health records (EHRs) can improve quality and efficiency in patient care. However, the intention to work with such a new system is often relatively low among employees because the work processes of the healthcare organization may change. Involving employees in an EHR implementation may increase their beliefs and perceived capabilities concerning the new system. The current study aimed to assess the role of involvement and its effects on sociocognitive beliefs regarding the implementation of a new EHR system. METHODS: The study was performed in June 2015 among all eligible employees of a hospital in the Netherlands. Both involved and noninvolved employees were invited to complete a paper-based questionnaire concerning their sociocognitive beliefs (i.e., attitude, social influence, self-efficacy, and intention) related to the EHR implementation. Independent sample t-tests were used to assess potential differences in sociocognitive beliefs between employees who were involved in the implementation process and those who were not. Effect sizes (Cohen's d) were calculated to indicate the standardized difference between the means. RESULTS: A total of 359 participants completed the paper-based questionnaire and were included in the analyses. Involved employees (n = 94) reported significantly higher levels of attitude (p < .001, d = .62), perceived self-efficacy (p = .01, d = .31), social support (p < .001, d = .68), and a higher intention to work with the new EHR system (p < .001, d = .60), compared with the group of employees who were not involved in the implementation process (n = 265). CONCLUSION: Involving employees during an EHR implementation appears to enhance employees' sociocognitive beliefs and increases their intention to work with the new system.

A longitudinal study on determinants of the intention to start smoking among Non-smoking boys and girls of high and low socioeconomic status.

BACKGROUND: This study identifies differences in socio-cognitive factors as they relate to the intention to smoke among boys and girls living in high socioeconomic status (HSES) and low socioeconomic status (LSES) neighborhoods. METHODS: A total of 1,643 children (aged 10-12 years) completed a web-based questionnaire assessing their intention, attitude, social influences, and self-efficacy toward smoking at baseline and at one year follow-up. Logistic regression analyses were conducted to examine the relations between intention and predictor variables (i.e. attitude, social influence, and self-efficacy). Three-way interaction terms were added to the first analysis to examine potential interactions of gender, socioeconomic status and predictor variables. A 3-way interaction effect was present, and therefore subgroup analyses for HSES and LSES boys and girls were warranted. RESULTS: The results indicated that positive attitudes toward smoking were related to the intention to smoke among HSES boys, whereas HSES girls had higher intentions to smoke if they perceived fewer disadvantages of smoking (OR: 0.42; 95 % CI: 0.22-0.82). The intention to smoke among LSES boys was predicted by perceived social norms (OR: 0.49; 95 % CI: 0.25-0.93); in LSES girls, the smoking behavior of people in their environment was most strongly related to their smoking intention (OR: 5.55; 95 % CI: 2.81-10.93). CONCLUSIONS: To prevent youth smoking, HSES boys and girls may benefit from interventions that address attitudes. Boys from an LSES neighborhood may profit from smoking prevention interventions that target social norms, while LSES girls may benefit from strategies aimed at resisting the influence of smokers in their environment. TRIAL REGISTRATION: The 'Fun without Smokes' study is approved by the Medical Ethics Committee of the Atrium-Orbis-Zuyd Hospital (NL32093.096.11/MEC 11-T-25) and registered in the Dutch Trial Register ( NTR3116 ).

A Web-based, computer-tailored smoking prevention program to prevent children from starting to smoke after transferring to secondary school: randomized controlled trial.

BACKGROUND: Smoking prevalence rates among Dutch children increase rapidly after they transit to secondary school, in particular among children with a low socioeconomic status (SES). Web-based, computer-tailored programs supplemented with prompt messages may be able to empower children to prevent them from starting to smoke when they transit to secondary school. OBJECTIVE: The main aim of this study is to evaluate whether computer-tailored feedback messages, with and without prompt messages, are effective in decreasing children's smoking intentions and smoking behavior after 12 and 25 months of follow-up. METHODS: Data were gathered at baseline (T0), and after 12 months (T1) and 25 months (T2) of follow-up of a smoking prevention intervention program called Fun without Smokes. A total of 162 schools were randomly allocated to a no-intervention control group, an intervention prompt group, or an intervention no-prompt group. A total of 3213 children aged 10 to 12 years old participated in the study and completed a Web-based questionnaire assessing their smoking intention, smoking behavior, and sociocognitive factors, such as attitude, social influence, and self-efficacy, related to smoking. After completion, children in the intervention groups received computer-tailored feedback messages in their own email inbox and those messages could be accessed on the intervention website. Children in the prompt group received prompt messages, via email and short message service (SMS) text messaging, to stimulate them to reuse the intervention website with nonsmoking content. Multilevel logistic regression analyses were performed using multiple imputations to assess the program effects on smoking intention and smoking behavior at T1 and T2. RESULTS: A total of 3213 children participated in the Fun without Smokes study at T0. Between T0 and T1 a total of 1067 children out of the original 3213 (33.21%) dropped out of the study. Between T0 and T2 the number of children that did not participate in the final measurement was 1730 out of the original 3213 (53.84%). No significant program effects were observed for any of the intervention groups compared to the control group at T1 for the intention to engage in smoking-prompt, OR 0.67 (95% CI 0.30-1.50), no-prompt, OR 0.76 (95% CI 0.34-1.67)-or for smoking behavior-prompt, OR 1.13 (95% CI 0.13-9.98), no-prompt, OR 0.50 (95% CI 0.04-5.59). Similar nonsignificant program effects were found at T2 for the intention to start smoking-prompt, OR 0.78 (95% CI 0.26-2.32), no-prompt, OR 1.31 (95% CI 0.45-3.82)-and smoking behavior-prompt, OR 0.53 (95% CI 0.12-2.47), no-prompt, OR 1.01 (95% CI 0.24-4.21). CONCLUSIONS: This study showed that the Web-based, computer-tailored feedback messages with and without prompt messages were not effective in modifying children's smoking intentions and smoking behavior as compared to no information. Future smoking prevention interventions are recommended to start closer to the age of actual smoking uptake. Furthermore, future studies on Web-based, computer-tailored smoking prevention programs should focus on assessing and controlling exposure to the educational content and the response to the prompt messages. TRIAL REGISTRATION: Netherlands Trial Register NTR3116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 (Archived by WebCite at http://www.webcitation.org/6O0wQYuPI).

Efficacy of a Web-based computer-tailored smoking prevention intervention for Dutch adolescents: randomized controlled trial.

BACKGROUND: Preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease. This study focuses on the effectiveness of a Web-based computer-tailored smoking prevention intervention aimed at adolescents. OBJECTIVE: The intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial. We hypothesized that the intervention would prevent smoking initiation among Dutch secondary school students aged 10-20 years and would have the largest smoking prevention effect among the age cohort of 14-16 years, as smoking uptake in that period is highest. METHODS: The intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants. A total of 89 secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition. Participants had to complete a Web-based questionnaire at baseline and at 6-month follow-up. Data on smoking initiation were collected from 897 students from these schools. To identify intervention effects, multilevel logistic regression analyses were conducted using multiple imputation. RESULTS: Smoking initiation among students aged 10-20 years was borderline significantly lower in the experimental condition as compared to the control condition 6 months after baseline (OR 0.25, 95% CI 0.05-1.21, P=.09). Additional analyses of the data for the 14-16 year age group showed a significant effect, with 11.5% (24/209) of the students in the control condition reporting initiation compared to 5.7% (10/176) in the experimental condition (OR 0.22, 95% CI 0.05-1.02, P=.05). No moderation effects were found regarding gender and educational level. CONCLUSIONS: The findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least 6 months, in particular among the age cohort of 14-16 years. Further research is needed to focus on long-term effects. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 77864351; http://www.controlled-trials.com/ISRCTN77864351 (Archived by WebCite at http://www.webcitation.org/6BSLKSTm5).

Do email and mobile phone prompts stimulate primary school children to reuse an Internet-delivered smoking prevention intervention?

BACKGROUND: Improving the use (eg, initial visit and revisits) of Internet-delivered interventions to promote healthy lifestyles such as non-smoking is one of the largest challenges in the field of eHealth. Prompts have shown to be effective in stimulating reuse of Internet-delivered interventions among adults and adolescents. However, evidence concerning effectiveness of prompts to promote reuse of a website among children is still scarce. OBJECTIVE: The aim of this study is to investigate (1) whether prompts are effective in promoting reuse of an intervention website containing information on smoking prevention for children, (2) whether the content of the prompt is associated with its effect in terms of reuse, and (3) whether there are differences between children who do or do not respond to prompts. METHODS: The sample of this cluster-randomized study consisted of 1124 children (aged 10-11 years) from 108 Dutch primary schools, who were assigned to the experimental group of an Internet-delivered smoking prevention intervention study. All participants completed a Web-based questionnaire on factors related to (non-)smoking. Schools were randomized to a no-prompt group (n=50) or a prompt group (n=58). All children could revisit the intervention website, but only the children in the prompt group received email and SMS prompts to revisit the website. Those prompt messages functioned as a teaser to stimulate reuse of the intervention website. Reuse of the website was objectively tracked by means of a server registration system. Repeated measures analysis of variance and linear regression analysis were performed to assess the effects of prompts on website reuse and to identify individual characteristics of participants who reuse the intervention website. RESULTS: Children in the prompt group reused the intervention website significantly more often compared to children in the no-prompt group (B=1.56, P<.001). Prompts announcing new animated videos (F1,1122=9.33, P=.002) and games about (non-)smoking on the website (F1,1122=8.28, P=.004) resulted in most reuse of the website. Within the prompt group, children with a low socioeconomic status (SES) reused the intervention website more often (B=2.19, P<.001) than children of high SES (B=0.93, P=.005). CONCLUSIONS: Prompts can stimulate children to reuse an intervention website aimed at smoking prevention. Prompts showed, furthermore, to stimulate children of a low SES slightly more to reuse an intervention website, which is often a difficult target group in terms of stimulating participation. However, the number of revisits was quite low, which requires further study into how prompts can be optimized in terms of content and frequency to improve the number of revisits. TRIAL REGISTRATION: Netherlands Trial Register Number: NTR3116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3116 (Archived by WebCite at http://www.webcitation.org/6O0wQYuPI).

Explaining socio-economic differences in intention to smoke among primary school children.

BACKGROUND: Smoking prevalence is higher among low socio-economic status (LSES) groups, and this difference may originate from a higher intention to smoke in childhood. This study aims to identify factors that explain differences in intention to smoke between children living in high socio-economic status (HSES) and LSES neighbourhoods. METHODS: Cross-sectional data were derived from the baseline assessment of a smoking prevention intervention study. Dutch primary school children, aged 10-11 years (N = 2,612), completed a web-based questionnaire about their attitude, subjective norm, self-efficacy expectations, modelling and intention to smoke. Linear and logistic regression analyses were performed to assess potential individual cognitive (attitude, subjective norm and self-efficacy) and social environmental (modelling) mediators between SES and intention to smoke. RESULTS: Multiple mediation models indicated that modelling mediated the association between SES (B = -0.09 (p < 0.01)) and intention to smoke (B = 1.06 (p < 0.01)). Mainly the father, mother and other family members mediated this association. Gender did not moderate the association between SES and intention to smoke and the potential mediators indicating that there are no differences in mediating factors between boys and girls. CONCLUSIONS: This study indicates that future smoking prevention studies may focus on the social environment to prevent smoking onset. However, replication of this study is warranted. TRIAL REGISTRATION: This study was approved by the Medical Ethics Committee of the Atrium-Orbis-Zuyd Hospital (NL32093.096.11 / MEC 11-T-25) and registered in the Dutch Trial Register (NTR3116).

Which factors play a role in Dutch health promotion professionals' decision to recruit actively primary schools to use a web-based smoking prevention programme?

BACKGROUND: Municipal Health Promotion Organisations (MHPOs) play an important role in promoting and disseminating prevention programmes, such as smoking prevention programmes, in schools. This study identifies factors that may facilitate or hinder MHPOs' willingness to recruit actively primary schools to use a smoking prevention programme. METHODS: In 2011, 31 Dutch MHPOs were invited to recruit schools to use a smoking prevention programme. All MHPO employees involved in smoking prevention activities (n = 68) were asked to complete a questionnaire assessing psychological factors and characteristics of their organisation that might affect their decision to be involved in active recruitment of schools. T-tests and multivariate analysis of variance assessed potential differences in psychological and organisational factors between active and non-active recruiters. RESULTS: A total of 45 professionals returned the questionnaire (66.2%). Active recruiters (n = 12) had more positive attitudes (p = 0.02), higher self-efficacy expectations (p < 0.01) and formulated more plans (p < 0.01) to recruit primary schools, compared with non-active recruiters. Organisational factors did not discriminate between active and non-active recruiters. CONCLUSIONS: Primarily psychological factors seem to be associated with MHPOs' decision to recruit schools actively. This indicates that creating more positive attitude, self-efficacy beliefs and formation of plans may help in getting more MHPOs involved in active recruitment procedures.

A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol.

BACKGROUND: Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. METHODS & DESIGN: This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years) entitled 'Fun without Smokes'. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT) with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils' smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the 'Fun without Smokes' website. The main outcome measures will be ever smoking and the utilisation of the 'Fun without Smokes' website. Measurements will be carried out at baseline, 12 months and 24 months of follow-up. DISCUSSION: The present study protocol describes the purpose, intervention design and study protocol of 'Fun without Smokes'. Expectations are that pupils receiving tailored advice will be less likely to smoke after 24 months in contrast to pupils in the control condition. Furthermore, tailored feedback letters and prompting is expected to be more effective than providing tailored feedback letters only. TRIAL REGISTRATION: Dutch Trial Register NTR3116.