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

Primary Purpose

Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
intensive multi-disciplinary education program on tobacco treatment for pharmacists
Control arm
Sponsored by
Qatar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Qatar Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Control arm

Arm Description

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.

Non-tobacco related training or education sessions will delivered to pharmacists in the control group.

Outcomes

Primary Outcome Measures

tobacco related knowledge post program
This outcome will be assessed using a survey instrument
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.

Secondary Outcome Measures

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
tobacco related self-efficacy difference between the 2 groups
This outcome will be assessed using a survey instrument
tobacco related attitudes difference between the 2 groups
This outcome will be assessed using a survey instrument

Full Information

First Posted
April 16, 2018
Last Updated
March 9, 2021
Sponsor
Qatar University
Collaborators
Hamad Medical Corporation, Weill Cornell Medical College in Qatar, International Islamic University Malaysia, University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT03518476
Brief Title
Evaluation of an Intensive Education Program on the Treatment of Tobacco Use Disorder for Pharmacists: a Randomized Controlled Trial
Official Title
Evaluation of an Intensive Education Program on the Treatment of Tobacco Use Disorder for Pharmacists: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qatar University
Collaborators
Hamad Medical Corporation, Weill Cornell Medical College in Qatar, International Islamic University Malaysia, University of Auckland, New Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Non-tobacco related training or education sessions will delivered to pharmacists in the control group.
Intervention Type
Behavioral
Intervention Name(s)
intensive multi-disciplinary education program on tobacco treatment for pharmacists
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control arm
Intervention Description
Participants in control arm will receive a non-tobacco related training or educational session
Primary Outcome Measure Information:
Title
tobacco related knowledge post program
Description
This outcome will be assessed using a survey instrument
Time Frame
at the end of the program (+ 1 DAY POST THE PROGRAM)
Title
tobacco cessation related skills difference between the 2 groups
Description
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.
Time Frame
at the end of the program (+ 1 DAY AFTER THE PROGRAM)
Secondary Outcome Measure Information:
Title
tobacco cessation related skills difference between the 2 groups
Description
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
Time Frame
3-6 months post intervention
Title
tobacco related self-efficacy difference between the 2 groups
Description
This outcome will be assessed using a survey instrument
Time Frame
at the end of the program (+ 1 DAY POST THE PROGRAM)
Title
tobacco related attitudes difference between the 2 groups
Description
This outcome will be assessed using a survey instrument
Time Frame
at the end of the program (+ 1 DAY POST THE PROGRAM)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Retail/community pharmacists practicing in Qatar will be eligible for participation in the study. Exclusion Criteria: None
Facility Information:
Facility Name
Qatar Univeristy
City
Doha
ZIP/Postal Code
2713
Country
Qatar

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35436957
Citation
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.
Results Reference
derived
PubMed Identifier
30621772
Citation
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.
Results Reference
derived

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

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