Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar

Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Health care providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible health care providers and are uniquely situated to initiate behavior change among patients. Many western studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease smoking burden.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Control arm (i.e: regular care); Behavioral: Pharmacist delivered smoking cessation program

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar
    • Primary Health Corporation (PHC) pharmacies
  • Doha, Qatar
    • Qatar Petroleum pharmacies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Eligible participants are:

• patients aged 18 years and older who currently smoke one or more cigarettes daily for 7 days, are motivated to quit i.e.: in the preparation stage of the stage-of-change model, able to communicate in Arabic or English and are willing and capable of attending the scheduled sessions at the study pharmacies.

Exclusion criteria are:

• use of other nicotine or tobacco products
• current use or use in the last 30 days of quit smoking aids or medications
• plan to leave Qatar in the next 12 months
• presence of any major medical condition that would prevent use of the nicotine replacement therapy including hypersensitivity to the products, history of or recent myocardial infarction, life-threatening arrhythmias, severe or worsening angina, uncontrolled hypertension and temporomandibular joint disease (in case of nicotine gum)
• pregnancy
• psychiatric illness or other debilitating condition that would interfere with participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm; Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).	Other: Control arm (i.e: regular care); Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
Experimental: Intervention arm; Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy. The sessions will be set at a date and time that is convenient for both the pharmacist and the participant. The pharmacist will deliver the program at a time different from his or her pharmacy duty regular time.	Behavioral: Pharmacist delivered smoking cessation program; The first session will be time-intensive taking around 30 minutes. In this session, the study pharmacist will facilitate the participant's preparation to quit. The participant will select a quit date within the next 2-4 weeks. The pharmacist will discuss with the participant the benefits of smoking cessation and will provide him or her with tailored behavioral and lifestyle strategies. To prevent nicotine withdrawal symptoms, the participant will be offered nicotine replacement therapy (NRT) The first follow-up session will be scheduled after 1 week of the participant's quit day and will take around 20 minutes. In this session, the pharmacist will determine the participant's smoking status and assess the NRT tolerability. • If the participant fails to quit smoking, the pharmacist will carefully review the participant's experience during the attempt to quit and will work through the identified problems; Other Names: Participants will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 7-day Point Prevalence Abstinence	Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days	3 months
Self-reported 30 Day Smoking Abstinence	Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days	3 months
Self-reported Continuous Abstinence at 3 Months	Self-reported continuous abstinence defined as having smoked no cigarettes since quit day	3 months
Self-reported 7-day Point Prevalence Abstinence	Defined as having smoked no cigarettes for the previous 7 days	6 months
Self-reported 30-day Point Prevalence Abstinence	Defined as having smoked no cigarettes in the last 30 days	6 months
Self-reported Continuous Abstinence	Defined as having smoked no cigarettes since quit day	6 months
Self-reported 7-day Point Prevalence Abstinence	Defined as having smoked no cigarettes for the previous 7 days	12 months
Self-reported 30-day Point Prevalence Abstinence	Defined as having smoked no cigarettes in the last 30 days	12 months
Self-reported Continuous Abstinence	Defined as having smoked no cigarettes since quit day at 12 months	12 months
Objective Smoking Abstinence	Smoking abstinence as objectively verified by the CO exhaled test at 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life	Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters	6 month

Collaborators and Investigators

• Sponsor: Qatar University
• Collaborators: Hamad Medical Corporation
• Investigators: Principal Investigator: Maguy S El Hajj, PharmD, Qatar University

Publications and helpful links

General Publications

• El Hajj MS, Kheir N, Al Mulla AM, Shami R, Fanous N, Mahfoud ZR. Effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: a randomized controlled trial. BMC Public Health. 2017 Feb 20;17(1):215. doi: 10.1186/s12889-017-4103-4.
• El Hajj MS, Kheir N, Al Mulla AM, Al-Badriyeh D, Al Kaddour A, Mahfoud ZR, Salehi M, Fanous N. Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial. Trials. 2015 Feb 26;16:65. doi: 10.1186/s13063-015-0570-z.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 20, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Smoking cessation; Pharmacist; Pharmacy; Qatar
• Other Study ID Numbers: NPRP 4 - 716 - 3 - 203