Evaluation of an Intensive Individualized Smoking Cessation Program Delivered by Pharmacists

Study Overview
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Brief Summary
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This study aims to look at the efficacy and impact of a pharmacist-led smoking cessation program. It will assess an intensive program and an abbreviated program, with the latter being evaluated for feasibility in community pharmacies. Participants will be in one of two groups: intensive or abbreviated. Smoking abstinence rates, self-efficacy and overall satisfaction will be compared. Additionally, a cost-effectiveness analysis will be executed to determine the feasibility of customized smoking cessation programs in community pharmacies across Newfoundland and Labrador.

Detailed Description
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One in five deaths in Canada is linked to smoking. It kills up to 50% of its users and over 7 million people each year. Smoking is also a risk factor for several harmful health consequences that affect the quality of life of those who smoke. It also results in substantial economic costs to society. Newfoundland and Labrador (NL) has the highest smoking prevalence of Canadian provinces; approximately 18.5% of Newfoundlanders smoke on a daily or occasional basis compared to the national average of 13.0%. The Conference Board of Canada reported this year that smoking costs the local NL economy approximately $135 million per year in direct healthcare costs and $53 million in indirect costs, for a total of $188 million. According to the CAN-ADAPTT Smoking Cessation Clinical Practice Guideline, several intensive counseling interventions are the most effective for smoking cessation. Offering a combination of counseling and pharmacotherapy increases the likelihood that a person will try to quit by 40-60%. Using this evidence, Memorial University's School of Pharmacy recently established a smoking cessation program at the Medication Therapy Services (MTS) Clinic. The program involves in-depth pharmacist consultation, which includes pharmacotherapy and multiple follow-up counseling sessions. The investigators propose to test the effectiveness of an intensive and abbreviated smoking cessation program (SCP) delivered by trained pharmacists at the MTS Clinic. They hope that findings from this study will inform stakeholders of the value of the program and of the pharmacists' role. If the program is determined to be effective it could be instrumental in applying smoking cessation programs in community pharmacies across the province, including rural and remote locations. To date there are only a small number of studies that use the randomized, controlled trial design to evaluate the effectiveness of pharmacist delivered interventions. In addition, data is lacking on the perspective of and satisfaction with smoking cessation services from the eyes of someone who participates in the program. Therefore, this study proposes to execute a randomized control trial to determine the effectiveness of a pharmacist-led smoking cessation program. Cost-effectiveness and a qualitative assessment of participant's journey to quit smoking will also be assessed.

Official Title
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Efficacy and Cost-Effectiveness of an Intensive and Abbreviated Individualized Smoking Cessation Support Program Delivered by Pharmacists: A Randomized Controlled Trial

Conditions
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Smoking Cessation, Smoking, Tobacco, Quality of Life

Intervention / Treatment
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* Behavioral: Intensive Smoking Cessation Group
* Behavioral: Abbreviated Smoking Cessation Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults including anyone 19 or older who wish to make a change in their smoking. Exclusion Criteria: People who do not smoke

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomly assigned to one of three groups: intensive smoking cessation program or an abbreviated smoking cessation program.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Smoking Cessation Group<br>This group will meet with a clinic pharmacist one on one over a period of about 12 weeks. They will have session ranging from 15 mins to 1 hour. Follow-up sessions will occur during quit week(week 1) and at weeks 2, 3, 4, 6, 8, 10, 12 and at 6 months. | Behavioral: Intensive Smoking Cessation Group<br>* This group will meet with the pharmacist more frequently and for longer periods than other groups.<br>* Other names: Intensive group;|
| Experimental: Abbreviated Smoking Cessation Group<br>This group will meet with a clinic pharmacist one on one over a period of about 12 weeks. They will have brief sessions (15-30 mins) at the end of week 1, week 4, week 12 and at 6 months. | Behavioral: Abbreviated Smoking Cessation Group<br>* This group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group.<br>* Other names: Abbreviated Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence Rate | To compare abstinence rates among participants who make a quit attempt, receiving either an intensive or abbreviated version of a pharmacist delivered smoking cessation program vs. those who receive usual care. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence Rate | To compare abstinence rates among participants who make a quit attempt, receiving either an intensive or abbreviated version of a pharmacist delivered smoking cessation program vs. those who receive usual care. | 3 months | 
| Quit Attempts | To compare the number of quit attempts (defined as 24 hours or more of not smoking) and smoking reduction between each group. | 3 months | 
| Quit Attempts | To compare the number of quit attempts (defined as 24 hours or more of not smoking) and smoking reduction between each group. | 6 months | 
| Change in baseline quality of life measured using the European Quality of Life-5 Dimensions 3 Levels (EQ-5D-3L) survey | To compare the change in quality of life between each group. | 0 and 6 months | 
| Change in baseline self-efficacy using a self efficacy survey | To compare the change in self-efficacy between each group. | 0 and 6 months | 
| Satisfaction survey | A measure of the satisfaction of participants with receiving a pharmacist delivered smoking cessation program, or quitting using usual care. | 6 months | 
| Cost-effectiveness using an estimate an incremental cost per quality adjusted life year (QALY) gained | To assess the cost-effectiveness of an intensive, and abbreviated, pharmacist delivered smoking cessation support program vs. usual care. The cost of delivering each service will be combined with the outcome of each to estimate an incremental cost per quality adjusted life year (QALY) gained. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking cessation, pharmacist, self-efficacy