Tobacco Treatment TrAining Network in Greece & Cyprus

NCT ID: NCT03040349

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2019-12-31

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.

Conditions

Tobacco Use

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TiTAN Intervention

The TiTAN Crete program has adapted the existing curricula and resources originally developed at the University of Ottawa Heart Institute and which are specific to primary practice settings. To facilitate maximum uptake the intervention program was adapted to reflect: language; cultural appropriateness; local patient beliefs and attitudes regarding tobacco-use and cessation; local social and clinical norms; provider perceptions surrounding 5As delivery; and, practice characteristics. The TiTAN multi-component training includes: 1) a 1-day foundational tobacco treatment training program for general practitioners, 2) the dissemination of provider and patient tools, and 3) E-blasts and webinars to supplement skills development and continuing medical education through e-learning.

Group Type: EXPERIMENTAL

Training

Intervention Type: BEHAVIORAL

The training program consists of a one-day core session addressing tobacco use with patients in the context of a busy primary care practice setting.The curriculum design was designed to be 2/3 theory and 1/3 practical. The program employs teaching techniques including role-play and case-study approaches known to enhance practice change.

Provider and Patient Tools

Intervention Type: BEHAVIORAL

Provider and patient tools were translated and adapted for use in primary care settings in Greece. A tool kit of resources will be distributed to providers which includes: patient tobacco use survey; provider consult form; provider medication reference sheet; patient quit plan booklet; and, waiting room posters. The provider consult form uses a checklist style set-up and provides real-time reminders for conducting an initial smoking cessation visit and follow-up appointments. The TiTAN Crete tools are available online at www.titan.uoc.gr

E-blast and Webinars

Intervention Type: BEHAVIORAL

In order to develop the network and continue to provide training opportunities for skills development we will develop a communication platform via an email list-serv to proactively communicate with providers who participate in the TiTAN program. A quarterly e-blast will be sent to all health care professionals involved in the TiTAN program. The e-blast will address the latest evidence-base practice, and skill development. Links to videos will also be provided. A webinar series will be scheduled to cover topics identified as interest by the primary health care providers. The webinar series will also be linked the Global Bridges EPACTT project.

Interventions

Training

The training program consists of a one-day core session addressing tobacco use with patients in the context of a busy primary care practice setting.The curriculum design was designed to be 2/3 theory and 1/3 practical. The program employs teaching techniques including role-play and case-study approaches known to enhance practice change.

Intervention Type: BEHAVIORAL

Provider and Patient Tools

Provider and patient tools were translated and adapted for use in primary care settings in Greece. A tool kit of resources will be distributed to providers which includes: patient tobacco use survey; provider consult form; provider medication reference sheet; patient quit plan booklet; and, waiting room posters. The provider consult form uses a checklist style set-up and provides real-time reminders for conducting an initial smoking cessation visit and follow-up appointments. The TiTAN Crete tools are available online at www.titan.uoc.gr

Intervention Type: BEHAVIORAL

E-blast and Webinars

In order to develop the network and continue to provide training opportunities for skills development we will develop a communication platform via an email list-serv to proactively communicate with providers who participate in the TiTAN program. A quarterly e-blast will be sent to all health care professionals involved in the TiTAN program. The e-blast will address the latest evidence-base practice, and skill development. Links to videos will also be provided. A webinar series will be scheduled to cover topics identified as interest by the primary health care providers. The webinar series will also be linked the Global Bridges EPACTT project.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: collaborator

Global Bridges Healthcare Alliance for Tobacco Dependence Treatment (Mayo Clinic)

UNKNOWN

Sponsor Role: collaborator

University of Ioannina

OTHER

Sponsor Role: collaborator

University of Nicosia

OTHER

Sponsor Role: collaborator

Pfizer Grants for Learning and Change

UNKNOWN

Sponsor Role: collaborator

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

Christor Lionis

Professor, Clinic of Social and Family Medicine, Dept Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christos Lionis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Crete

Locations

University of Crete

Heraklion, Crete, Greece

Countries

Greece

Central Contacts

Christos Lionis

Role: CONTACT

lionis@uoc.gr

302810394621

Sophia Papadakis

Role: CONTACT

sophiapapadakis@gmail.com

306982551782

Facility Contacts

Christos Lionis, MD, PhD

Role: primary

lionis@uoc.gr

Sophia Papadakis, PhD

Role: backup

sophia.papadakis@gmail.com

306982551782

Other Identifiers

ELKE4599

Identifier Type: -

Identifier Source: org_study_id