Evaluation of an Intensive Education Program on the Treatment of Tobacco Use Disorder for Pharmacists: a Randomized Controlled Trial

Study Overview
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Brief Summary
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In Qatar, tobacco use is one of the main causes of premature deaths and preventable diseases. As per the 2013 Global Adult Tobacco Survey (GATS), 12.1% of adults and 20.2% of men in Qatar smoke tobacco, and 55.4% of this smoke an average of 16 cigarettes or more per day. Moreover, 15.7% of school students aged 13 to 15 years currently use some form of tobacco according to the 2013 Global Youth Tobacco Survey (GYTS). In Qatar, tobacco-related diseases including cardiovascular diseases and cancers are highly prevalent. In an effort to reduce tobacco use, Qatar has ratified the WHO Framework Convention on Tobacco Control (FCTC) and has implemented many tobacco control initiatives. In spite of these measures, tobacco use is still rising in Qatar. Pharmacists practicing in retail/community pharmacy are often the first port of call for individuals requiring health advice in general. Evidence has proven that they have a pivotal role in health promotion and disease prevention including tobacco cessation. Hence, pharmacists have excellent opportunities to reduce tobacco use in Qatar. Yet, ambulatory and community pharmacists in Qatar are not sufficiently contributing to tobacco control. Based on published data, only 21% of community pharmacists in Qatar always or most of the time ask patients about their smoking status. Furthermore, when asked about their smoking cessation training, 89% of pharmacists did not receive any kind of education or training about smoking cessation counseling in the past. In an effort to build the capacity of pharmacists in Qatar, the aim of the proposed study is to design, implement and evaluate an intensive education program on tobacco treatment for pharmacists in Qatar. The study will be a prospective randomized controlled trial comparing the effectiveness of the education program on pharmacists' tobacco cessation-related knowledge, attitudes, self-efficacy, and skills.

Official Title
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Evaluation of an Intensive Education Program on the Treatment of Tobacco Use Disorder for Pharmacists: a Randomized Controlled Trial

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: intensive multi-disciplinary education program on tobacco treatment for pharmacists
* Other: Control arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Retail/community pharmacists practicing in Qatar will be eligible for participation in the study. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Participants in the intervention group will participate in an intensive education program delivered by a multi-disciplinary group of educators, researchers, and clinicians with expertise in tobacco control and tobacco dependence treatment. The program will be delivered over 4 days (run over 2 weekends) with an average of eight contact hours per day (a total of 32 contact hours) at Qatar University. | Behavioral: intensive multi-disciplinary education program on tobacco treatment for pharmacists<br>* Participants in the intervention group will participate in an intensive education program delivered by a multi-disciplinary group of educators, researchers, and clinicians with expertise in tobacco control and tobacco dependence treatment. The program will be delivered over 4 days (run over 2 weekends) with an average of eight contact hours per day (a total of 32 contact hours) at Qatar University.<br>|
| Active Comparator: Control arm<br>Non-tobacco related training or education sessions will delivered to pharmacists in the control group. | Other: Control arm<br>* Participants in control arm will receive a non-tobacco related training or educational session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tobacco related knowledge post program | This outcome will be assessed using a survey instrument | at the end of the program (+ 1 DAY POST THE PROGRAM) | 
| tobacco cessation related skills difference between the 2 groups | This outcome will be assessed using OSCE (Objective Structured Clinical Examination). Pharmacist's practical skills in the delivery of effective tobacco cessation will be assessed through the use of a performance-based assessment such as Objective Structured Clinical Examination (OSCE). Examples of skills to be assessed include communication skills in general, counselling skills, law and professional ethics, and interviewing skills. We propose a 5 to 8 station OSCE that will target core competencies and skills covered in the program. In the OSCE, each participant will be allocated 10 mins to interact with a standardized patient who will be trained using a validated script. Performance of participants will be assessed using validated assessment checklists. | at the end of the program (+ 1 DAY AFTER THE PROGRAM) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tobacco cessation related skills difference between the 2 groups | The secondary endpoint of the study will be the performance difference in relation to skills in the practice setting between the intervention and the control groups assessed using the simulated client approach. In this phase, the study will evaluate whether participants in intervention and control groups will offer appropriate tobacco cessation counseling and will recommend proper tobacco cessation aids in their practice setting. Using a simulated client approach to data collection 3 to 6 months post program, the study will assess the quality of advice and recommendations of participants given to simulated clients asking for help in quitting smoking. Simulated clients using designed and validated case scenarios will visit participants in both groups. The clients will be selected to resemble the sociodemographic and practice characteristics of Qatar population and residents. Objective assessment forms will be developed using tobacco cessation guideline | 3-6 months post intervention | 
| tobacco related self-efficacy difference between the 2 groups | This outcome will be assessed using a survey instrument | at the end of the program (+ 1 DAY POST THE PROGRAM) | 
| tobacco related attitudes difference between the 2 groups | This outcome will be assessed using a survey instrument | at the end of the program (+ 1 DAY POST THE PROGRAM) |