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Tobacco Treatment TrAining Network in Greece & Cyprus (TiTAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040349
Recruitment Status : Unknown
Verified January 2017 by Christor Lionis, University of Crete.
Recruitment status was:  Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Christor Lionis, University of Crete

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.


Condition or disease Intervention/treatment Phase
Tobacco Use Behavioral: Training Behavioral: Provider and Patient Tools Behavioral: E-blast and Webinars Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Primary Care Tobacco Treatment TrAining Network in Greece & Cyprus
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Provider Performance in the Delivery of Cessation Treatments assessed via patient exit survey [ Time Frame: Change between pre-intervention and post intervention (3-months) ]
    Performance in the delivery of each of the 5As will be assessed via exit interview with eligible patients. The survey will ask participants to respond either "yes" or "no" or "don't know" regarding whether their PHC provider asked them about their smoking status (ask); advised them to quit smoking (advise); assessed their readiness to quit (assess); provided assistance with quitting (assist); prescribed pharmacotherapy, provided self-help materials, and arranged follow-up support


Secondary Outcome Measures :
  1. Provider Self-efficacy assessed by questionnaire [ Time Frame: Change between pre-intervention and post-training (1-month) ]
    Provider self-efficacy will be assessed before and after the intervention

  2. Provider knowledge assessed by questionnaire [ Time Frame: Change between pre-intervention and post intervention (3-months) ]
    Provider knowledge of evidence-based tobacco treatment guidelines will be assessed using a brief 15-item knowledge assessment to examine key concepts addressed as part of training. The knowledge assessment has been tested as part of the TiTAN Crte project.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040349


Contacts
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Contact: Christos Lionis 302810394621 lionis@uoc.gr
Contact: Sophia Papadakis 306982551782 sophiapapadakis@gmail.com

Locations
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Greece
University of Crete
Heraklion, Crete, Greece, 71500
Contact: Christos Lionis, MD, PhD       lionis@uoc.gr   
Contact: Sophia Papadakis, PhD    306982551782    sophia.papadakis@gmail.com   
Principal Investigator: Christos Lionis, MD, PhD         
Principal Investigator: Sophia Papadakis, PhD         
Principal Investigator: Constantine Vardavas, MD, PhD         
Sub-Investigator: George Samoutis, MD, PhD         
Sub-Investigator: Andrew Pipe, MD         
Sub-Investigator: Athina Tatsioni, MD, PhD         
Sub-Investigator: Emmanuel Smyrnakis, MD, PhD         
Sponsors and Collaborators
University of Crete
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
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Principal Investigator: Christos Lionis, MD, PhD University of Crete
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Responsible Party: Christor Lionis, Professor, Clinic of Social and Family Medicine, Dept Medicine, University of Crete
ClinicalTrials.gov Identifier: NCT03040349    
Other Study ID Numbers: ELKE4599
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christor Lionis, University of Crete:
primary care
greece
cyprus
tobacco use treatment
evidence-based guidelines