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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN10306198 |
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Date of registration:
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01/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tobacco treatment training network in Crete, Greece: TiTAN-Crete
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Scientific title:
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Primary care tobacco treatment training network in Crete: a before and after study |
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Date of first enrolment:
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13/05/2015 |
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Target sample size:
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1368 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN10306198 |
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Study type:
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Interventional |
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Study design:
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Two-arm pre-/post-cluster control group design (Treatment)
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Name:
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Christos
Lionis |
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Address:
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Clinic of Social and Family Medicine, Faculty of Medicine
71003
Heraklion
Greece |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria for general practitioners (GPs):
1. GPs from the practice-based research network at the University of Crete, Heraklion (intervention group)
2. GPs from the region Rethymno (control group)
Inclusion criteria for patients:
1. Current smoker (>5 cigarette/day on most days of the week)
2. 18 years and older
3. Scheduled for an annual exam or non-urgent medical appointment
4. Able to read and/or understand Greek
5. Has the mental capacity to provide informed consent and complete study protocols
Exclusion criteria: 1. Participant does not have the mental capacity to complete study questionnaires
2. Participant is under the age of 18
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Smoking cessation
Not Applicable
Tobacco use
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Intervention(s)
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The intervention program involves key opinion leaders, training, office support tools and coaching. The program has a core session which is followed up by 4 shorter booster sessions. Booster sessions are given over a 2-4 month period following the initial core session:
1. Core session content is composed of 2/3 theory and 1/3 practical (on the job). Core content includes: the burden of tobacco control in Greece, evidence-based tobacco treatment practices in primary care, first-line pharmacotherapies, behavioural counselling techniques for use in busy clinical settings, strategies for intervening with patients ready and not ready to quit smoking, special populations, setting up your practice for success, your role as clinician-advocate in tobacco control. Special emphasis will be placed upon training the primary health care (PHC) providers in overall tobacco control so that they develop the knowledge to act as policy advocates at a regional and national level. The program will employ teaching techniques such as role-play and case study approaches known to enhance up-take into practice.
2. Booster sessions are designed to reinforce the adoption of new practice behaviours and offer skill-based training, including case-based training focused on patients within a provider’s own practice. Local faculty (opinion leaders) as well as international Global Bridges faculty will deliver program training and tailor its content to meet local needs. Participating clinicians will be provided with the necessary tools (tobacco use screener, provider consult form, patient self-help materials) to support their engagement of the program.
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Primary Outcome(s)
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1. Program adoption: participation in TiTAN-Crete Global Bridges training program components and use of the Global Bridges Project Toolkit
2. Provider knowledge: knowledge of evidence-based tobacco treatment guidelines will be assessed using a brief 5-10 item knowledge assessment developed by project team
3. Theory of planned behavior constructs: attitudes, beliefs, control beliefs, subjective norms, normative beliefs, perceived behavioral control, intentions in next 6-months related to tobacco treatment delivery will be assessed using a pre-/post-intervention provider survey
4. Provider performance in the delivery of cessation treatments: performance in the delivery of each of the 3As ('ask, advise, assess') will be assessed via exit interview with eligible patients. The survey will ask participants to respond yes/no/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 (arrange).
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Secondary Outcome(s)
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PHC provider satisfaction with the program and sustainability of the program will be assessed by survey at the end of trial. Providers will be asked to report on the quality of global bridges training program, quality of in-practice support, quality support materials, feasibility of maintaining tobacco treatment delivery in 80% of patients, barriers, suggestions for improvement and suggestions for continued engagement of primary care practitioner network.
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Secondary ID(s)
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Global Bridges ID: 1352258
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Source(s) of Monetary Support
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Global Bridges (USA)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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