Efficacy and Cost of State Quitline Policies
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|ClinicalTrials.gov Identifier: NCT00366977|
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : May 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Tobacco Use Cessation Cost-effectiveness||Behavioral: Multi-session telephone counseling Drug: NRT patches||Phase 3|
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:
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.
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.
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).
- Determine the incremental cost per year-of-life saved for the alternative policies relative to usual care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4614 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Cost of State Quitline Policies|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
- Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.
- Participant self-reported (at 6 and 12 months) any tobacco use by type
- amount used per day
- stage of change
- number of quit attempts
- use of health plan and community cessation resources
- intervention total cost, cost per participant, and cost per quit
- incremental cost effectiveness ratios for each intervention compared to baseline
- patterns of pharmacotherapy use
- out-of-pocket expenses for cessation activities.
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): NCT00366977
|United States, Oregon|
|Kaiser Permanente Center for Health Research|
|Portland, Oregon, United States, 97227|
|Oregon Health Division/Center for Disease Prevention Epidemiology|
|Portland, Oregon, United States, 97232|
|United States, Washington|
|Free and Clear, Inc.|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Jack F. Hollis, PhD||Kaiser Permanente Foundation Hospitals/Center for Health Research|
|Principal Investigator:||Timothy A McAfee, MD||Group Health Center for Health Promotion|
|Principal Investigator:||Michael J Stark, PhD||Oregon Health Division/Center for Disease Prevention Epidemiology|