Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
4614 participants
Study Classification
INTERVENTIONAL
Study Start Date
2000-06-30
Study Completion Date
2005-01-31
Brief Summary
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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.
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Detailed Description
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Anti-tobacco media campaigns in many states are motivating large numbers of smokers to seek advice, assistance, and support to make their cessation efforts more successful. Like many other states, Oregon has sponsored the implementation of a statewide telephone quitline to provide information, referrals, and cessation support for callers. Two investigators on this proposal (Hollis and McAfee) have a contract with the State of Oregon to provide the Oregon Quitline (OQL) services. The purpose of the proposed research effort is to collaborate further with State representatives to answer key policy questions about how to most effectively support smokers who call the OQL for assistance.
Our overall aim is to recruit 4,500 callers to the OQL to participate in a 3 x 2 randomized trial to compare the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies regarding 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 and community cessation services. Costs will be assessed separately from the perspective of the patients, health plan, the State (i.e., OQL), and society. The specific aims are described below:
1. Compare the efficacy of three policies for supporting OQL callers:
* Brief counseling with referral to caller's health plan cessation services (standard service);
* Moderate counseling, referral to health plan, and one follow-up call to reinforce use of health plan services;
* Moderate counseling, referral, and availability a multi-session telephonic intervention.
2. Compare the efficacy of two policies regarding the provision of nicotine replacement:
* No offer of nicotine replacement (current policy);
* An offer of free nicotine replacement patches.
3. Determine the costs and cost per quit of the additional policy interventions relative to usual care (i.e., standard service) from the following perspectives:
* Societal perspective (total incremental costs per incremental quit);
* State perspective (incremental cost per quit for OQL services);
* Health plan perspective (based on differences in use of health plan cessation services);
* Participant's perspective (based on differences in out-of-pocket expenses).
4. Determine the incremental cost per year-of-life saved for the alternative policies relative to usual care.
Our overall aim is to recruit 4,500 callers to the OQL to participate in a 3 x 2 randomized trial to compare the cost and cost effectiveness of three levels of behavioral intervention. We will also test two different policies regarding 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 and community cessation services. Costs will be assessed separately from the perspective of the patients, health plan, the State (i.e., OQL), and society. The specific aims are described below:
1. Compare the efficacy of three policies for supporting OQL callers:
* Brief counseling with referral to caller's health plan cessation services (standard service);
* Moderate counseling, referral to health plan, and one follow-up call to reinforce use of health plan services;
* Moderate counseling, referral, and availability a multi-session telephonic intervention.
2. Compare the efficacy of two policies regarding the provision of nicotine replacement:
* No offer of nicotine replacement (current policy);
* An offer of free nicotine replacement patches.
3. Determine the costs and cost per quit of the additional policy interventions relative to usual care (i.e., standard service) from the following perspectives:
* Societal perspective (total incremental costs per incremental quit);
* State perspective (incremental cost per quit for OQL services);
* Health plan perspective (based on differences in use of health plan cessation services);
* Participant's perspective (based on differences in out-of-pocket expenses).
4. Determine the incremental cost per year-of-life saved for the alternative policies relative to usual care.
Conditions
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Smoking Cessation
Tobacco Use Cessation
Cost-effectiveness
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
Interventions
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Multi-session telephone counseling
Intervention Type
BEHAVIORAL
NRT patches
Intervention Type
DRUG
Eligibility Criteria
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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
* 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.
* Current or planned pregnancy or breast-feeding
* Heart attack within the preceding month.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Department of Human Services, Oregon
OTHER_GOV
Sponsor Role
collaborator
Kaiser Permanente
OTHER
Sponsor Role
lead
Responsible Party
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Kaiser Permanente Center for Health Research
Principal Investigators
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Jack F. Hollis, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente Foundation Hospitals/Center for Health Research
Timothy A McAfee, MD
Role: PRINCIPAL_INVESTIGATOR
Group Health Center for Health Promotion
Michael J Stark, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health Division/Center for Disease Prevention Epidemiology
Locations
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Kaiser Permanente Center for Health Research
Portland, Oregon, United States
Site Status
Oregon Health Division/Center for Disease Prevention Epidemiology
Portland, Oregon, United States
Site Status
Free and Clear, Inc.
Seattle, Washington, United States
Site Status
Countries
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United States
References
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Other Identifiers
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1 RO1-CA86242-1
Identifier Type: -
Identifier Source: org_study_id
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