Tobacco Treatment TrAining Network in Greece & Cyprus

NCT03040349

Last updated date
Study Location
University of Crete
Heraklion, Crete, 71500, Greece
Contact
302810394621

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

302810394621

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tobacco Use
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- • 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- n/a

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Tobacco UseTobacco Treatment TrAining Network in Greece & Cyprus
NCT03040349
  1. Heraklion, Crete
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Tobacco Treatment TrAining Network in Greece & Cyprus
Official Title  ICMJE Evaluation of the Primary Care Tobacco Treatment TrAining Network in Greece & Cyprus
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tobacco Use
Intervention  ICMJE
  • Behavioral: 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.
  • 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
  • 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.
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Behavioral: Training
  • Behavioral: Provider and Patient Tools
  • Behavioral: E-blast and Webinars
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040349
Other Study ID Numbers  ICMJE ELKE4599
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Christor Lionis, University of Crete
Study Sponsor  ICMJE University of Crete
Collaborators  ICMJE
  • Ottawa Heart Institute Research Corporation
  • Aristotle University Of Thessaloniki
  • Global Bridges Healthcare Alliance for Tobacco Dependence Treatment (Mayo Clinic)
  • University of Ioannina
  • University of Nicosia
  • Pfizer Grants for Learning and Change
Investigators  ICMJE
Principal Investigator:Christos Lionis, MD, PhDUniversity of Crete
PRS Account University of Crete
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP