Smoking CessationNCT03597607
Evaluation of an Intensive Individualized Smoking Cessation Program Delivered by Pharmacists
A study testing Intensive Smoking Cessation Group and Abbreviated Smoking Cessation Group in people with Smoking Cessation and Smoking, Tobacco, run by Memorial University of Newfoundland at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Tobacco, Quality of Life
- What is being tested?
- Intensive Smoking Cessation Group and Abbreviated Smoking Cessation Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 18 Sep 2018to 5 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults including anyone 19 or older who wish to make a change in their smoking.
Who cannot join
- People who do not smoke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Cost-Effectiveness of an Intensive and Abbreviated Individualized Smoking Cessation Support Program Delivered by Pharmacists: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Smoking Cessation, Smoking, Tobacco, Quality of Life
- Being tested
- Intensive Smoking Cessation Group, Abbreviated Smoking Cessation Group
- Keywords
- Smoking cessation, pharmacist, self-efficacy
- Medical subject headings
- Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Smoking Cessation GroupBehavioural
Also called Intensive group
This group will meet with the pharmacist more frequently and for longer periods than other groups.
Abbreviated Smoking Cessation GroupBehavioural
Also called Abbreviated Group
This group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Smoking Cessation Group | Experimental | 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. Receives: Behavioral: Intensive Smoking Cessation Group |
| Abbreviated Smoking Cessation Group | Experimental | 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. Receives: Behavioral: Abbreviated Smoking Cessation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 and 6 months
Change in baseline self-efficacy using a self efficacy survey
To compare the change in self-efficacy between each group.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start18 Sep 2018
- Primary completion25 Sep 2020
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomly assigned to one of three groups: intensive smoking cessation program or an abbreviated smoking cessation program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial University of Newfoundland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terri Genge, Memorial University of Newfoundland
- Investigators
- Terri Genge, Principal investigator, Memorial University, School of PharmacyLeslie Phillips, Principal investigator, Memorial University, School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597607
- Sponsor's protocol ID
- HREB 6946
- Status last verified
- Apr 2022
- First submitted
- 20 Nov 2017
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided.
Publications
The World Health Organization: Tobacco (http://www.who.int/mediacentre/factsheets/fs339/en/)
Dobrescu, Bhandari, Sutherland and Dinh (2017). The Costs of Tobacco Use in Canada, 2012. The Conference Board of Canada. Retrieved from http://www.conferenceboard.ca/e-library/abstract.aspx?did=9185
National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/
PubMed 24455788Reid JL, Hammond D, Rynard VL, Madill CL, Burkhalter R. Tobacco Use in Canada: Patterns and Trends, 2017 Edition. Waterloo, ON: Propel Centre for Population Health Impact, University of Waterloo.
Government of Newfoundland and Labrador. (2017). The way forward: Realizing our potential. Retrieved from http://thewayforward.gov.nl.ca/documents/Realizing_our_potential.pdf
Locke, Wade. (2017). State of N.L. Economy: From Bad to Worse. Presentation by Department of Economics, Memorial University.
Gagnon-Arpin, Isabelle, Alexandru Dobrescu, Greg Sutherland, Carole Stonebridge, and Thy Dinh. The Value of Expanded Pharmacy Services in Canada. Ottawa: The Conference Board of Canada, 2017.
CAN-ADAPTT. (2011). Canadian Smoking Cessation Clinical Practice Guideline. Toronto, Canada: Canadian Action Network for the Advancement, Dissemination and Adoption of Practice-informed Tobacco Treatment, Centre for Addiction and Mental Health.
Aveyard P, Begh R, Parsons A, West R. Brief opportunistic smoking cessation interventions: a systematic review and meta-analysis to compare advice to quit and offer of assistance. Addiction. 2012 Jun;107(6):1066-73. doi: 10.1111/j.1360-0443.2011.03770.x. Epub 2012 Feb 28.
PubMed 22175545Canadian Pharmacists Association. Joint Statement on Smoking Cessation - Tobacco: the Role of Health Professionals in Smoking Cessation. https://www.pharmacists.ca/cpha-ca/assets/File/cpha-on-the-issues/PPSmokingCessation.pdf
Canadian Pharmacists Association. Professional Development-QUIT program. https://www.pharmacists.ca/education-practice-resources/professional-development/quit/
Newfoundland and Labrador Pharmacy Board. Prescribing by Pharmacists Standards of Pharmacy Practice. http://www.nlpb.ca/media/SOPP-Prescribing-by-Pharmacists-Aug2015-revFeb2016.pdf
Fai SC, Yen GK, Malik N. Quit rates at 6 months in a pharmacist-led smoking cessation service in Malaysia. Can Pharm J (Ott). 2016 Sep;149(5):303-312. doi: 10.1177/1715163516662894. Epub 2016 Aug 9.
PubMed 27708676Bock BC, Hudmon KS, Christian J, Graham AL, Bock FR. A tailored intervention to support pharmacy-based counseling for smoking cessation. Nicotine Tob Res. 2010 Mar;12(3):217-25. doi: 10.1093/ntr/ntp197. Epub 2010 Jan 25.
PubMed 20100808Saba M, Diep J, Saini B, Dhippayom T. Meta-analysis of the effectiveness of smoking cessation interventions in community pharmacy. J Clin Pharm Ther. 2014 Jun;39(3):240-7. doi: 10.1111/jcpt.12131. Epub 2014 Jan 13.
PubMed 24749899
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost-Effectiveness of an Intensive and Abbreviated Individualized Smoking Cessation Support Program Delivered by Pharmacists: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03597607
- Acronym / sponsor ID
- HREB 6946
- Conditions
- Smoking Cessation, Smoking, Tobacco, Quality of Life
- Keywords
- Smoking cessation, pharmacist, self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Memorial University of NewfoundlandUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomly assigned to one of three groups: intensive smoking cessation program or an abbreviated smoking cessation program.
| Arm | Type | Receives |
|---|---|---|
| Intensive Smoking Cessation Group | Experimental | Behavioral: Intensive Smoking Cessation GroupThis 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. |
| Abbreviated Smoking Cessation Group | Experimental | Behavioral: Abbreviated Smoking Cessation GroupThis 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults including anyone 19 or older who wish to make a change in their smoking.
Key exclusion criteria (1 listed)
- People who do not smoke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Smoking Cessation GroupAlso: Intensive groupThis group will meet with the pharmacist more frequently and for longer periods than other groups. | Behavioural | Intensive Smoking Cessation Group |
| Abbreviated Smoking Cessation GroupAlso: Abbreviated GroupThis group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group. | Behavioural | Abbreviated Smoking Cessation Group |
Primary outcome
Abstinence Rate
Time frame: 6 months
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.
7 secondary outcomes
Abstinence Rate
Time frame: 3 months
Quit Attempts
Time frame: 3 months
Quit Attempts
Time frame: 6 months
Change in baseline quality of life measured using the European Quality of Life-5 Dimensions 3 Levels (EQ-5D-3L) survey
Time frame: 0 and 6 months
Change in baseline self-efficacy using a self efficacy survey
Time frame: 0 and 6 months
Satisfaction survey
Time frame: 6 months
Cost-effectiveness using an estimate an incremental cost per quality adjusted life year (QALY) gained
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- BackgroundThe World Health Organization: Tobacco (http://www.who.int/mediacentre/factsheets/fs339/en/)
- BackgroundDobrescu, Bhandari, Sutherland and Dinh (2017). The Costs of Tobacco Use in Canada, 2012. The Conference Board of Canada. Retrieved from http://www.conferenceboard.ca/e-library/abstract.aspx?did=9185
- Background: PubMed 24455788National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK179276/
- BackgroundReid JL, Hammond D, Rynard VL, Madill CL, Burkhalter R. Tobacco Use in Canada: Patterns and Trends, 2017 Edition. Waterloo, ON: Propel Centre for Population Health Impact, University of Waterloo.
- BackgroundGovernment of Newfoundland and Labrador. (2017). The way forward: Realizing our potential. Retrieved from http://thewayforward.gov.nl.ca/documents/Realizing_our_potential.pdf
- BackgroundLocke, Wade. (2017). State of N.L. Economy: From Bad to Worse. Presentation by Department of Economics, Memorial University.
- BackgroundGagnon-Arpin, Isabelle, Alexandru Dobrescu, Greg Sutherland, Carole Stonebridge, and Thy Dinh. The Value of Expanded Pharmacy Services in Canada. Ottawa: The Conference Board of Canada, 2017.
- BackgroundCAN-ADAPTT. (2011). Canadian Smoking Cessation Clinical Practice Guideline. Toronto, Canada: Canadian Action Network for the Advancement, Dissemination and Adoption of Practice-informed Tobacco Treatment, Centre for Addiction and Mental Health.
- Background: PubMed 22175545Aveyard P, Begh R, Parsons A, West R. Brief opportunistic smoking cessation interventions: a systematic review and meta-analysis to compare advice to quit and offer of assistance. Addiction. 2012 Jun;107(6):1066-73. doi: 10.1111/j.1360-0443.2011.03770.x. Epub 2012 Feb 28.
- BackgroundCanadian Pharmacists Association. Joint Statement on Smoking Cessation - Tobacco: the Role of Health Professionals in Smoking Cessation. https://www.pharmacists.ca/cpha-ca/assets/File/cpha-on-the-issues/PPSmokingCessation.pdf
- BackgroundCanadian Pharmacists Association. Professional Development-QUIT program. https://www.pharmacists.ca/education-practice-resources/professional-development/quit/
- BackgroundNewfoundland and Labrador Pharmacy Board. Prescribing by Pharmacists Standards of Pharmacy Practice. http://www.nlpb.ca/media/SOPP-Prescribing-by-Pharmacists-Aug2015-revFeb2016.pdf
- Individual participant dataSharing planned: Undecided. Undecided.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terri Genge principal investigator
Memorial University, School of Pharmacy
Leslie Phillips principal investigator
Memorial University, School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Smoking Cessation Group and Abbreviated Smoking Cessation Group in people with Smoking Cessation and Smoking, Tobacco, run by Memorial University of Newfoundland at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03597607, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.