Design The evaluation design schema is presented in Appendix B. A pre-post evaluation design will be used. All PHC providers will be surveyed before, immediately following the training session and 3-months after the intervention program is delivered. Additionally, a random sample of providers will be identified from which a cross-sectional sample of eligible smokers from their practice will be surveyed pre- and post-intervention to assess provider performance in the delivery of 5As tobacco treatment intervention. Qualitative interviews will be completed with a sub-sample of providers at the end of year 1.
Provider Recruitment An invitation letter will be sent to all GPs and other PHC providers in the target region. We will include both GPs working in private and public practices in the target region. A follow-up phone call will be placed to all providers by a member of the investigative team, one week after the invitation was sent to confirm interest in participation. We will aim to reach all providers with a minimum of three attempts being made to reach all providers before classifying them as "unable to contact". Participating providers will sign an information sheet and consent form.
Provider Pre- and Post-Assessment Survey All participating providers will a complete a survey prior to the foundational training (Time 1) which will assess demographic variables and outcomes of interest. Immediately following the training (Time 2) and 3-months following the training (Time 3), providers will complete follow-up surveys which will re-assess outcomes of interest and satisfaction with the intervention program.
Semi-structured interviews will be conducted with 10 PHC providers at the end of year 1 in order to inform year 2 activities. Providers will be asked to self-identify and will be drawn from all sub-regions. These interviews will be conducted by a trained team member and will be recorded. Key themes will be identified and extracted.
Additionally in order to gain an overall picture of the number of initial and consultations for smoking cessation made by participating providers, we will collect information on basic activities for a 1-year period following the introduction of the training program. A contact log has been created which can be used prospectively by providers and or used retrospectively (ie. chart audit).
Patient-Level Sampling In order to gather information about rates of 5As delivery, a sub-sample of 20 GPs will be randomly selected for patient level data collection. From the sub-sample of randomly selected providers, 16 eligible patients will be recruited before (time 1) and after (time 2) intervention delivery.
Patient-level data collection will be limited to GPs as other health care professionals are likely working alongside the GPs as opposed to a separate practice. Provider eligibility for the patient-level evaluation will include:
- is a GP working in a public or private primary care practice setting;
- participation in TiTAN training program;
- GP has not participated in other smoking cessation training in the previous 2-3 years;
- sees a minimum of 15 patients per day seen in the practice in order to ensure efficient use of data collection resources; and,
- located within a reasonable distance from where the training will take place in order to minimize costs associated with travel.
Randomization and Informed Consent Randomization will be stratified by region involved in the present study (Crete, Athens, Ioannina, Thessaloniki, Cyprus) and type of practice (private/public) and years of experience. An independent third party researcher will randomly select GPs from the recruitment list provided for inclusion in the present study. GPs selected for participation in the patient-level sampling will be informed via telephone and asked to sign an informed consent for this component of the study.
Patient Pre-Post Data Collection The pre-intervention assessment will be conducted prior to implementing the intervention program to establish baseline activities of the practice. During the screening period, a research assistant will be located in the clinic waiting room. The research assistant will screen consecutive patients scheduled for an annual exam or non-urgent appointment for eligibility using the study screening form.
Recruitment statistics will be recorded using the recruitment tracking sheet]in order to calculate prevalence of tobacco use (total number of tobacco users/total number of patients), reasons for ineligibility and reasons for non-participation.
Eligible patients who agree to participate in the study will review and sign the study information sheet and consent form and contact sheet with the Research Assistant. Participants will be tracked using the study master list and will be assigned a study ID. Only the study ID will be included on the study survey. Consenting patients will then be given the exit survey to complete at the end of the their visit with their primary care provider. The survey will collect information about whether their physician or another clinician asked about their smoking status (ask); advised them to quit smoking (advise); and provided cessation assistance (assist). The exit survey will also gather socio-demographic and smoking history, beliefs, and intentions.
The post-intervention assessment will involve the collection of data from a second cross-sectional sample of 16 patients approximately 3-months following the implementation of the intervention within the practice. The methods described in the pre-intervention assessment will be repeated at the post-assessment.