Evaluation of an Intensive Individualized Smoking Cessation Program Delivered by Pharmacists
NCT ID: NCT03597607
Last Updated: 2022-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2018-09-18
2022-04-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intensive Smoking Cessation Group
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.
Intensive Smoking Cessation Group
This group will meet with the pharmacist more frequently and for longer periods than other groups.
Abbreviated Smoking Cessation Group
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.
Abbreviated Smoking Cessation Group
This group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group.
Interventions
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Intensive Smoking Cessation Group
This group will meet with the pharmacist more frequently and for longer periods than other groups.
Abbreviated Smoking Cessation Group
This group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
ALL
Yes
Sponsors
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Memorial University of Newfoundland
OTHER
Responsible Party
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Terri Genge
Assistant Professor
Principal Investigators
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Terri Genge
Role: PRINCIPAL_INVESTIGATOR
Memorial University, School of Pharmacy
Leslie Phillips
Role: PRINCIPAL_INVESTIGATOR
Memorial University, School of Pharmacy
Locations
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School of Pharmacy
St. John's, Newfoundland and Labrador, Canada
Countries
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References
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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/
Reid 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.
Canadian Association of Occupational Therapists; Canadian Association of Social Workers; Canadian Dental Association; Canadian Medical Association; Canadian Nurses Association; Canadian Pharmacists Association; Canadian Physiotherapy Association; Canadian Psychological Association; Canadian Society of Respiratory Therapists. Tobacco: the role of health professionals in smoking cessation. Joint statement. J Can Dent Assoc. 2001 Mar;67(3):134-5. No abstract available.
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.
Bock 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.
Saba 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.
Dent LA, Harris KJ, Noonan CW. Randomized trial assessing the effectiveness of a pharmacist-delivered program for smoking cessation. Ann Pharmacother. 2009 Feb;43(2):194-201. doi: 10.1345/aph.1L556. Epub 2009 Feb 3.
Zillich AJ, Ryan M, Adams A, Yeager B, Farris K. Effectiveness of a pharmacist-based smoking-cessation program and its impact on quality of life. Pharmacotherapy. 2002 Jun;22(6):759-65. doi: 10.1592/phco.22.9.759.34073.
Maguire TA, McElnay JC, Drummond A. A randomized controlled trial of a smoking cessation intervention based in community pharmacies. Addiction. 2001 Feb;96(2):325-31. doi: 10.1046/j.1360-0443.2001.96232516.x.
Kennedy DT, Giles JT, Chang ZG, Small RE, Edwards JH. Results of a smoking cessation clinic in community pharmacy practice. J Am Pharm Assoc (Wash). 2002 Jan-Feb;42(1):51-6. doi: 10.1331/108658002763538071.
Vial RJ, Jones TE, Ruffin RE, Gilbert AL. Smoking cessation program using nicotine patches: linking hospital to the community. J Pharm Pract Res. 2002;32:57-62.
Smith MD, McGhan WF, Lauger G. Pharmacist counseling and outcomes of smoking cessation. Am Pharm. 1995 Aug;NS35(8):20-9; 32. doi: 10.1016/s0160-3450(15)30095-7.
Crealey GE, McElnay JC, Maguire TA, O'Neill C. Costs and effects associated with a community pharmacy-based smoking-cessation programme. Pharmacoeconomics. 1998 Sep;14(3):323-33. doi: 10.2165/00019053-199814030-00008.
McGhan WF, Smith MD. Pharmacoeconomic analysis of smoking-cessation interventions. Am J Health Syst Pharm. 1996 Jan 1;53(1):45-52. doi: 10.1093/ajhp/53.1.45.
Brown TJ, Todd A, O'Malley C, Moore HJ, Husband AK, Bambra C, Kasim A, Sniehotta FF, Steed L, Smith S, Nield L, Summerbell CD. Community pharmacy-delivered interventions for public health priorities: a systematic review of interventions for alcohol reduction, smoking cessation and weight management, including meta-analysis for smoking cessation. BMJ Open. 2016 Feb 29;6(2):e009828. doi: 10.1136/bmjopen-2015-009828.
Thavorn K, Chaiyakunapruk N. A cost-effectiveness analysis of a community pharmacist-based smoking cessation programme in Thailand. Tob Control. 2008 Jun;17(3):177-82. doi: 10.1136/tc.2007.022368. Epub 2008 Feb 19.
Tran MT, Holdford DA, Kennedy DT, Small RE. Modeling the cost-effectiveness of a smoking-cessation program in a community pharmacy practice. Pharmacotherapy. 2002 Dec;22(12):1623-31. doi: 10.1592/phco.22.17.1623.34118.
Other Identifiers
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HREB 6946
Identifier Type: -
Identifier Source: org_study_id
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