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

NCT ID: NCT00818207

Last Updated: 2012-03-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation Insurance Coverage

Keywords

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Smoking cessation quit rates reimbursement drug coverage effectiveness cost-effectiveness health policy drug utilization adherence urine cotinine.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Full Smoking Cessation Treatment Coverage (100%)

Intervention Type OTHER

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.

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.

Group Type OTHER

No Smoking Cessation Treatment Coverage (0%)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Burnaby, British Columbia, Canada

Site Status

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Chilliwack, British Columbia, Canada

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Coquitlam, British Columbia, Canada

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Kamloops, British Columbia, Canada

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Kelowna, British Columbia, Canada

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Langley, British Columbia, Canada

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North Vancouver, British Columbia, Canada

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Penticton, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Paradise, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Sydney, Nova Scotia, Canada

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Windsor, Nova Scotia, Canada

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Aylmer, Ontario, Canada

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Bolton, Ontario, Canada

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Collingwood, Ontario, Canada

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Corunna, Ontario, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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Ottawa, Ontario, Canada

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Sarnia, Ontario, Canada

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Stayner, Ontario, Canada

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Strathroy, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Woodstock, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Charlottetown, Prince Edward Island, Canada

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Montague, Prince Edward Island, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 24885542 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051116&StudyName=Impact%20Of%20Smoking%20Cessation%20Treatment%20Reimbursement%20On%20The%20Quit%20Rates%20In%20Smokers%20Motivated%20To%20Quit

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

Other Identifiers

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A3051116

Identifier Type: -

Identifier Source: org_study_id