Clinical trial NCT03040349: Tobacco Treatment TrAining Network in Greece & Cyprus
Official title: Evaluation of the Primary Care Tobacco Treatment TrAining Network in Greece & Cyprus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use
Keywords: primary care
greece
cyprus
tobacco use treatment
evidence-based guidelines
Lead sponsor: University of Crete
Sponsor class: OTHER
Collaborators: name: Ottawa Heart Institute Research Corporation
name: Aristotle University Of Thessaloniki
name: Global Bridges Healthcare Alliance for Tobacco Dependence Treatment (Mayo Clinic)
name: University of Ioannina
name: University of Nicosia
name: Pfizer Grants for Learning and Change
First posted: 2017-02-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall aim of the TiTAN Greece \& Cyprus project is to expand the Global Bridges Tobacco Treatment Training Network in the WHO Europe region through a focus on primary health care providers in Greece and Cyprus. A robust evaluation will be conducted alongside the TiTAN program. A pre-post evaluation will be used to examine the impact on the TiTAN program on:

1. Provider engagement (number of providers attending training), number of local champions;
2. Provider knowledge, beliefs, perceived behavioral control, and intentions related to the delivery of tobacco treatment;
3. Rates of evidence-based tobacco treatments (5As) are delivered to patients who smoke;
4. Provider satisfaction with training program, resources, and network outreach activity and areas for improvement; and
5. Estimates on the impact on patient-level outcomes including number of patient quit smoking at 1 and 3-month follow-up.

All PHC providers will be surveyed before and after the intervention program is delivered. We will randomly select a sub-sample of providers and will survey patients from their practice before and after the intervention program in order to validate changes in 5As delivery. Qualitative interviews will be completed with a sub-sample of providers at the end of year 1.

Detailed description: 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.

Procedures

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:

1. is a GP working in a public or private primary care practice setting;
2. participation in TiTAN training program;
3. GP has not participated in other smoking cessation training in the previous 2-3 years;
4. sees a minimum of 15 patients per day seen in the practice in order to ensure efficient use of data collection resources; and,
5. 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.

Eligibility criteria: Inclusion Criteria:

* • are a current smoker (\>5 cigarette per day on most days of the week);

  * are 18 years of age or older;
  * are scheduled for an annual exam or non-urgent medical appointment at the primary care clinic;
  * are able to read and/or understand Greek; and,
  * have the mental capacity to provide informed consent and complete study protocols.

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Provider Performance in the Delivery of Cessation Treatments assessed via patient exit survey
timeFrame: Change between pre-intervention and post intervention (3-months)
Secondary outcomes:
measure: Provider Self-efficacy assessed by questionnaire
timeFrame: Change between pre-intervention and post-training (1-month)
measure: Provider knowledge assessed by questionnaire
timeFrame: Change between pre-intervention and post intervention (3-months)
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University of Crete
state: Crete
Study officials:
affiliation: University of Crete
name: Christos Lionis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: