ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03518476
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Hamad Medical Corporation
Weill Cornell Medical College in Qatar
International Islamic University Malaysia
University of Auckland, New Zealand
Information provided by (Responsible Party):
Dr. Maguy El Hajj, Qatar University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: intensive multi-disciplinary education program on tobacco treatment for pharmacists Other: Control arm Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluation of an Intensive Education Program on the Treatment of Tobacco Use Disorder for Pharmacists: a Randomized Controlled Trial
Estimated Study Start Date : September 14, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

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.
Behavioral: intensive multi-disciplinary education program on tobacco treatment for pharmacists
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.
Other: Control arm
Participants in control arm will receive a non-tobacco related training or educational session




Primary Outcome Measures :
  1. 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

  2. tobacco cessation related skills difference between the 2 groups [ Time Frame: at the end of the program (+ 1 DAY AFTER THE PROGRAM) ]

    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.



Secondary Outcome Measures :
  1. 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


  2. tobacco related self-efficacy difference between the 2 groups [ Time Frame: at the end of the program (+ 1 DAY POST THE PROGRAM) ]
    This outcome will be assessed using a survey instrument

  3. tobacco related attitudes difference between the 2 groups [ Time Frame: at the end of the program (+ 1 DAY POST THE PROGRAM) ]
    This outcome will be assessed using a survey instrument



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Retail/community pharmacists practicing in Qatar will be eligible for participation in the study.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518476


Contacts
Contact: Maguy El Hajj 0097444035577 maguyh@qu.edu.qa

Locations
Qatar
Qatar Univeristy Not yet recruiting
Doha, Qatar, 2713
Contact: Maguy S El Hajj, PharmD         
Sponsors and Collaborators
Qatar University
Hamad Medical Corporation
Weill Cornell Medical College in Qatar
International Islamic University Malaysia
University of Auckland, New Zealand

Responsible Party: Dr. Maguy El Hajj, Associate Professor and Chair of Clinical Pharmacy and Practice Section, Qatar University
ClinicalTrials.gov Identifier: NCT03518476     History of Changes
Other Study ID Numbers: QatarU
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders