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Clinical Trials/NCT03040349
NCT03040349UnknownNot Applicable

Evaluation of the Primary Care Tobacco Treatment TrAining Network in Greece & Cyprus

University of Crete1 site in 1 country300 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
Provider Performance in the Delivery of Cessation Treatments assessed via patient exit survey

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

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.

Intervention: E-blast and Webinars (Behavioral)

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.

Intervention: Training (Behavioral)

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.

Intervention: Provider and Patient Tools (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christor Lionis

Professor, Clinic of Social and Family Medicine, Dept Medicine

University of Crete

Study Sites (1)

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