NCT03518476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 14, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

April 16, 2018

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • tobacco cessation related skills difference between the 2 groups

    3-6 months post intervention

  • tobacco related self-efficacy difference between the 2 groups

    at the end of the program (+ 1 DAY POST THE PROGRAM)

  • tobacco related attitudes difference between the 2 groups

    at the end of the program (+ 1 DAY POST THE PROGRAM)

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Other: Control arm

Interventions

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 arm

Participants in control arm will receive a non-tobacco related training or educational session

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qatar Univeristy

Doha, 2713, Qatar

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Pharmacists

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Chair of Clinical Pharmacy and Practice Section

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 8, 2018

Study Start

September 14, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations