Evaluation of an Intensive Individualized Smoking Cessation Program Delivered by Pharmacists

NCT03597607 | Completed

• 1 other identifier: HREB 6946
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Smoking, Tobacco; Quality of Life

Keywords

Smoking cessation; pharmacist; self-efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Abstinence Rate

  3 months

• Quit Attempts

  3 months

• Quit Attempts

  6 months

• Change in baseline quality of life measured using the European Quality of Life-5 Dimensions 3 Levels (EQ-5D-3L) survey

  0 and 6 months

• Change in baseline self-efficacy using a self efficacy survey

  0 and 6 months

Study Arms (2)

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.

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.

Behavioral: Abbreviated Smoking Cessation Group

Interventions

Intensive Smoking Cessation Group BEHAVIORAL

This group will meet with the pharmacist more frequently and for longer periods than other groups.

Also known as: Intensive group

Intensive Smoking Cessation Group

Abbreviated Smoking Cessation Group BEHAVIORAL

This group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group.

Also known as: Abbreviated Group

Abbreviated Smoking Cessation Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• People who do not smoke

Sponsors & Collaborators

• Memorial University of Newfoundland: lead

Study Sites (1)

School of Pharmacy

St. John's, Newfoundland and Labrador, A1A0L1, Canada

Location

Related Publications (26)

• The World Health Organization: Tobacco (http://www.who.int/mediacentre/factsheets/fs339/en/)

  BACKGROUND

• 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

  BACKGROUND

• 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/

  PMID: 24455788 BACKGROUND

• 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.

  BACKGROUND

• Government of Newfoundland and Labrador. (2017). The way forward: Realizing our potential. Retrieved from http://thewayforward.gov.nl.ca/documents/Realizing_our_potential.pdf

  BACKGROUND

• Locke, Wade. (2017). State of N.L. Economy: From Bad to Worse. Presentation by Department of Economics, Memorial University.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22175545 BACKGROUND

• 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.

  PMID: 11315390 BACKGROUND

• Canadian Pharmacists Association. Professional Development-QUIT program. https://www.pharmacists.ca/education-practice-resources/professional-development/quit/

  BACKGROUND

• Newfoundland and Labrador Pharmacy Board. Prescribing by Pharmacists Standards of Pharmacy Practice. http://www.nlpb.ca/media/SOPP-Prescribing-by-Pharmacists-Aug2015-revFeb2016.pdf

  BACKGROUND

• 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.

  PMID: 27708676 BACKGROUND

• 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.

  PMID: 20100808 BACKGROUND

• 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.

  PMID: 24749899 BACKGROUND

• 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.

  PMID: 19193572 BACKGROUND

• 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.

  PMID: 12066966 BACKGROUND

• 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.

  PMID: 11182878 BACKGROUND

• 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.

  PMID: 11833517 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 7677052 BACKGROUND

• 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.

  PMID: 10186470 BACKGROUND

• 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.

  PMID: 8719289 BACKGROUND

• 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.

  PMID: 26928025 BACKGROUND

• 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.

  PMID: 18285385 BACKGROUND

• 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.

  PMID: 12495172 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Study Officials

• Terri Genge

  Memorial University, School of Pharmacy

  PRINCIPAL INVESTIGATOR

• Leslie Phillips

  Memorial University, School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be informed of their group allocation. Health care providers of the intervention will be aware of which program to deliver, therefore knowing group allocation. The investigator will be aware of group allocation. Outcomes will be assessed by a blind data analyst.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants randomly assigned to one of three groups: intensive smoking cessation program or an abbreviated smoking cessation program.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: July 24, 2018
• Study Start: September 18, 2018
• Primary Completion: September 25, 2020
• Study Completion: April 5, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

CA (1)