Smoking Cessation Clinical Trial
Official title:
Efficacy and Cost of State Quitline Policies
Verified date | April 2011 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
State-sponsored anti-tobacco campaigns are motivating large numbers of smokers to seek advice, assistance, and support to make their cessation efforts more successful. Like many states, Oregon has sponsored the implementation of a statewide telephone quitline to provide information, referrals, and cessation support for callers. This study will answer key policy questions about how to most effectively support smokers who call the Oregon Quitline for assistance. The specific aims are to recruit 4,500 callers to participate in a 3 x 2 randomized trial comparing the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies on the availability of nicotine patch therapy. Subjects will be interviewed by telephone at 6 and 12 months to assess smoking status, quit attempts, and use of health plan anc community cessation services. Costs will be assessed separately from the perspectives of the patients, health plans, the State (i.e., Oregon Quitline), and society. Cost per quit and cost per year quality-adjusted years of life saved will be calculated from each of these perspectives.
Status | Completed |
Enrollment | 4614 |
Est. completion date | January 2005 |
Est. primary completion date | January 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18+ - Speak English or Spanish - Oregon resident - Smoke 5 or more cigarettes/day - Planning to quit within 30 days (or quit within in last 7 days) - Consent to random assignment and follow-up Exclusion Criteria: - Health plan benefit includes free multi-session telephone counseling - Current or planned pregnancy or breast-feeding - Heart attack within the preceding month. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Center for Health Research | Portland | Oregon |
United States | Oregon Health Division/Center for Disease Prevention Epidemiology | Portland | Oregon |
United States | Free and Clear, Inc. | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Department of Human Services, Oregon, Group Health Cooperative, National Cancer Institute (NCI) |
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* Note: There are 56 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat. | |||
Secondary | Participant self-reported (at 6 and 12 months) any tobacco use by type | |||
Secondary | amount used per day | |||
Secondary | stage of change | |||
Secondary | number of quit attempts | |||
Secondary | use of health plan and community cessation resources | |||
Secondary | intervention total cost, cost per participant, and cost per quit | |||
Secondary | incremental cost effectiveness ratios for each intervention compared to baseline | |||
Secondary | patterns of pharmacotherapy use | |||
Secondary | out-of-pocket expenses for cessation activities. |
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