Clinical trial NCT03597607: Evaluation of an Intensive Individualized Smoking Cessation Program Delivered by Pharmacists
Official title: Efficacy and Cost-Effectiveness of an Intensive and Abbreviated Individualized Smoking Cessation Support Program Delivered by Pharmacists: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking, Tobacco
Quality of Life
Keywords: Smoking cessation
pharmacist
self-efficacy
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomly assigned to one of three groups: intensive smoking cessation program or an abbreviated smoking cessation program.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Adults including anyone 19 or older who wish to make a change in their smoking.

Exclusion Criteria:

* People who do not smoke

Primary outcomes:
measure: Abstinence Rate
timeFrame: 6 months
Secondary outcomes:
measure: Abstinence Rate
timeFrame: 3 months
measure: Quit Attempts
timeFrame: 3 months
measure: Quit Attempts
timeFrame: 6 months
measure: Change in baseline quality of life measured using the European Quality of Life-5 Dimensions 3 Levels (EQ-5D-3L) survey
timeFrame: 0 and 6 months
measure: Change in baseline self-efficacy using a self efficacy survey
timeFrame: 0 and 6 months
measure: Satisfaction survey
timeFrame: 6 months
measure: Cost-effectiveness using an estimate an incremental cost per quality adjusted life year (QALY) gained
timeFrame: 6 months
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: School of Pharmacy
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University, School of Pharmacy
name: Terri Genge
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial University, School of Pharmacy
name: Leslie Phillips
role: PRINCIPAL_INVESTIGATOR
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