Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit (ACCESSATION)

A Pragmatic, Randomized, Controlled Study Evaluating The Impact Of Access To Smoking Cessation Treatment Reimbursement On The Proportion Of Successful Quitters In A Canadian Population Of Smokers Motivated To Quit

This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Insurance Coverage
• Intervention / Treatment: Other: Full Smoking Cessation Treatment Coverage (100%); Other: No Smoking Cessation Treatment Coverage (0%)

• Study Type: Interventional
• Enrollment (Actual): 1380
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Burnaby, British Columbia, Canada, V5G 1T4
      • Pfizer Investigational Site
    • Chilliwack, British Columbia, Canada, V2P 4M9
      • Pfizer Investigational Site
    • Coquitlam, British Columbia, Canada, V3K 3P4
      • Pfizer Investigational Site
    • Kamloops, British Columbia, Canada, V2C 1K7
      • Pfizer Investigational Site
    • Kelowna, British Columbia, Canada, V1Y 3G8
      • Pfizer Investigational Site
    • Langley, British Columbia, Canada, V3A 4H9
      • Pfizer Investigational Site
    • North Vancouver, British Columbia, Canada, V7N 4M2
      • Pfizer Investigational Site
    • Penticton, British Columbia, Canada, V2A 5C8
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Pfizer Investigational Site
    • Vancouver, British Columbia, Canada, V5K 1K3
      • Pfizer Investigational Site
    • Victoria, British Columbia, Canada, V8R 1J8
      • Pfizer Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R2V 4W3
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Pfizer Investigational Site
    • Winnipeg, Manitoba, Canada, R2M 3T2
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
      • Pfizer Investigational Site
    • Paradise, Newfoundland and Labrador, Canada, A1L 1C6
      • Pfizer Investigational Site
    • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
      • Pfizer Investigational Site
    • St. John's, Newfoundland and Labrador, Canada, A1E 2E2
      • Pfizer Investigational Site
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1C6
      • Pfizer Investigational Site
    • Windsor, Nova Scotia, Canada, B0N 2T0
      • Pfizer Investigational Site
  • Ontario
    • Aylmer, Ontario, Canada, N5H 1K9
      • Pfizer Investigational Site
    • Bolton, Ontario, Canada, L7E 1E8
      • Pfizer Investigational Site
    • Collingwood, Ontario, Canada, L9Y 1W3
      • Pfizer Investigational Site
    • Corunna, Ontario, Canada, N0N 1G0
      • Pfizer Investigational Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • Pfizer Investigational Site
    • Hamilton, Ontario, Canada, L8N 4A6
      • Pfizer Investigational Site
    • London, Ontario, Canada, N5W 6A2
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6C 4Y7
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6H 4P2
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6P 1A9
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6A 5W9
      • Pfizer Investigational Site
    • London, Ontario, Canada, N5Y 5K7
      • Pfizer Investigational Site
    • London, Ontario, Canada, N5W 3C6
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6A 5G6
      • Pfizer Investigational Site
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Pfizer Investigational Site
    • Ottawa, Ontario, Canada, K2C 3R2
      • Pfizer Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Pfizer Investigational Site
    • Stayner, Ontario, Canada, L0M 1S0
      • Pfizer Investigational Site
    • Strathroy, Ontario, Canada, N7G 1Y7
      • Pfizer Investigational Site
    • Thornhill, Ontario, Canada, L4J 6W6
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M8V 3X8
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M9W 4L6
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M3H 5S4
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M5G 1N8
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M6L 3C9
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M9V 4B4
      • Pfizer Investigational Site
    • Woodstock, Ontario, Canada, N4S 5P5
      • Pfizer Investigational Site
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 1L2
      • Pfizer Investigational Site
    • Charlottetown, Prince Edward Island, Canada, C1A 5Y9
      • Pfizer Investigational Site
    • Montague, Prince Edward Island, Canada, C0A 1R0
      • Pfizer Investigational Site
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 3X1
      • Pfizer Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7K 7H9
      • Pfizer Investigational Site
    • Saskatoon, Saskatchewan, Canada, S7K 6Y6
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Daily smokers (10 cigarettes per day or more);
• Smokers motivated to make a quit attempt within the next 14 days;
• Potential subjects must be outpatients;
• A subject must have a stable mental and physical medical condition (as per investigator's judgment).

Exclusion Criteria:

• A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance;
• A subject with an unknown drug insurance status;
• A subject living in a household where there is someone already recruited in the study;
• A subject with an unfilled SCT prescription issued within the past three months or with an unused SCT product;
• A subject with a life-threatening illness (ie, known or suspected cancer or other disease with a life expectancy of less than one year).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Full Smoking Cessation Treatment Coverage (100%); A subject randomized to the intervention group will be eligible for smoking cessation treatment (SCT) reimbursement during the 26-week period following the randomization.	Other: Full Smoking Cessation Treatment Coverage (100%); This is a pragmatic study in which the intervention is a health policy (SCT reimbursement). Champix (varenicline), Zyban (bupropion) and NRTs (nicotine replacement therapies; patches, gums) are SCT eligible for reimbursement. Prescriptions will be issued as per the most recent version of the Product Monograph of the prescribed SCT or equivalent.
Other: No Smoking Cessation Treatment Coverage (0%); Subjects in the control group choosing to quit using an SCT method will not be eligible for smoking cessation treatment (SCT) reimbursement and, thus, will have to purchase their treatment out of pocket.	Other: No Smoking Cessation Treatment Coverage (0%); None of the subjects recruited in the study have access to SCT reimbursement in real-life. As such, subjects randomized to the control group represent lack of SCT coverage in real-life and are considered to receive standard of care for smoking cessation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence	Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?"	Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco	PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days?" confirmed by negative urine cotinine test results (defined as cotinine levels less than [<]200 nanograms per milliliter [ng/mL]).	Week 26
Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52	CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions "Have you smoked any cigarettes (even a puff) since the last contact/visit?" at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit?" and (b) urine cotinine test results were neither positive (greater than or equal to [≥]200 ng/mL) nor missing.	Week 26, Week 39, and Week 52
Percentage of Participants With 7-Day PP of Abstinence at Week 13	PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?"	Week 13
Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52	LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?" and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52	Week 26 to Week 52

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Selby P, Brosky G, Oh P, Raymond V, Arteaga C, Ranger S. A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION). BMC Public Health. 2014 May 7;14:433. doi: 10.1186/1471-2458-14-433.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: January 6, 2009
• First Submitted That Met QC Criteria: January 6, 2009
• First Posted (Estimate): January 7, 2009

Study Record Updates

• Last Update Posted (Estimate): March 30, 2012
• Last Update Submitted That Met QC Criteria: February 29, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: adherence; effectiveness; Smoking cessation; cost-effectiveness; drug utilization; health policy; quit rates; reimbursement; drug coverage; urine cotinine.
• Other Study ID Numbers: A3051116