- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03518476
Evaluation of an Intensive Education Program on the Treatment of Tobacco Use Disorder for Pharmacists: a Randomized Controlled Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Doha, Qatar, 2713
- Qatar Univeristy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Retail/community pharmacists practicing in Qatar will be eligible for participation in the study.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
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.
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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.
|
Active Comparator: Control arm
Non-tobacco related training or education sessions will delivered to pharmacists in the control group.
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Participants in control arm will receive a non-tobacco related training or educational session
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tobacco related knowledge post program
Time Frame: at the end of the program (+ 1 DAY POST THE PROGRAM)
|
This outcome will be assessed using a survey instrument
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at the end of the program (+ 1 DAY POST THE PROGRAM)
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tobacco cessation related skills difference between the 2 groups
Time Frame: at the end of the program (+ 1 DAY AFTER THE PROGRAM)
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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
Time Frame: 3-6 months post intervention
|
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
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tobacco related self-efficacy difference between the 2 groups
Time Frame: at the end of the program (+ 1 DAY POST THE PROGRAM)
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This outcome will be assessed using a survey instrument
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at the end of the program (+ 1 DAY POST THE PROGRAM)
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tobacco related attitudes difference between the 2 groups
Time Frame: at the end of the program (+ 1 DAY POST THE PROGRAM)
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This outcome will be assessed using a survey instrument
|
at the end of the program (+ 1 DAY POST THE PROGRAM)
|
Collaborators and Investigators
Publications and helpful links
General Publications
- El Hajj MS, Awaisu A, Nik Mohamed MH, Saleh RA, Al Hamad NM, Kheir N, Mahfoud ZR. Assessment of an intensive education program for pharmacists on treatment of tobacco use disorder using an objective structured clinical examination: a randomized controlled trial. BMC Med Educ. 2022 Apr 18;22(1):289. doi: 10.1186/s12909-022-03331-9.
- El Hajj MS, Awaisu A, Kheir N, Mohamed MHN, Haddad RS, Saleh RA, Alhamad NM, Almulla AM, Mahfoud ZR. Evaluation of an intensive education program on the treatment of tobacco-use disorder for pharmacists: a study protocol for a randomized controlled trial. Trials. 2019 Jan 8;20(1):25. doi: 10.1186/s13063-018-3068-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QatarU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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