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Evaluation of an Intensive Individualized Smoking Cessation Program Delivered by Pharmacists

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ClinicalTrials.gov Identifier: NCT03597607
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Terri Genge, Memorial University of Newfoundland

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 three groups: intensive, abbreviated or usual care. Smoking abstinence rates, quality of life, self-efficacy 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking, Tobacco Quality of Life Behavioral: Intensive Smoking Cessation Group Behavioral: Abbreviated Smoking Cessation Group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants randomly assigned to one of three groups: intensive smoking cessation program, abbreviated smoking cessation program or usual care.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Efficacy and Cost-Effectiveness of an Intensive and Abbreviated Individualized Smoking Cessation Support Program Delivered by Pharmacists: A Randomized Controlled Trial
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : March 18, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Intensive Smoking Cessation Group
This group will meet with the pharmacist more frequently and for longer periods than other groups.
Other Name: Intensive group

Experimental: 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.
Behavioral: Abbreviated Smoking Cessation Group
This group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group.
Other Name: Abbreviated Group

No Intervention: Usual care group
The usual care group will be given a package of independent resources that could aid them to quit smoking on their own. They will not receive intervention by a clinic pharmacist.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Abstinence Rate [ Time Frame: 3 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.

  2. Quit Attempts [ Time Frame: 3 months ]
    To compare the number of quit attempts (defined as 24 hours or more of not smoking) and smoking reduction between each group.

  3. Quit Attempts [ Time Frame: 6 months ]
    To compare the number of quit attempts (defined as 24 hours or more of not smoking) and smoking reduction between each group.

  4. 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 ]
    To compare the change in quality of life between each group.

  5. Change in baseline self-efficacy using a self efficacy survey [ Time Frame: 0 and 6 months ]
    To compare the change in self-efficacy between each group.

  6. Satisfaction survey [ Time Frame: 6 months ]
    A measure of the satisfaction of participants with receiving a pharmacist delivered smoking cessation program, or quitting using usual care.

  7. Cost-effectiveness using an estimate an incremental cost per quality adjusted life year (QALY) gained [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597607


Contacts
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Contact: Beulah Jesso 709-864-4536 bjesso@mun.ca

Locations
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Canada, Newfoundland and Labrador
School of Pharmacy Recruiting
St. John's, Newfoundland and Labrador, Canada, A1A0L1
Contact: Beulah Jesso    709-864-4536    bjesso@mun.ca   
Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
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Principal Investigator: Terri Genge Memorial University, School of Pharmacy

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
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.
Canadian 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
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.

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Responsible Party: Terri Genge, Assistant Professor, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT03597607     History of Changes
Other Study ID Numbers: HREB 6946
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terri Genge, Memorial University of Newfoundland:
Smoking cessation
pharmacist
self-efficacy