NCT03040349

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

January 30, 2017

Last Update Submit

January 31, 2017

Conditions

Keywords

primary caregreececyprustobacco use treatmentevidence-based guidelines

Outcome Measures

Primary Outcomes (1)

  • Provider Performance in the Delivery of Cessation Treatments assessed via patient exit survey

    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

    Change between pre-intervention and post intervention (3-months)

Secondary Outcomes (2)

  • Provider Self-efficacy assessed by questionnaire

    Change between pre-intervention and post-training (1-month)

  • Provider knowledge assessed by questionnaire

    Change between pre-intervention and post intervention (3-months)

Study Arms (1)

TiTAN Intervention

EXPERIMENTAL

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: TrainingBehavioral: Provider and Patient ToolsBehavioral: E-blast and Webinars

Interventions

TrainingBEHAVIORAL

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.

TiTAN Intervention

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

TiTAN Intervention

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.

TiTAN Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Crete

Heraklion, Crete, 71500, Greece

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christos Lionis, MD, PhD

    University of Crete

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Lionis

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Clinic of Social and Family Medicine, Dept Medicine

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 2, 2017

Study Start

February 1, 2017

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

February 2, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations