Efficacy and Cost of State Quitline Policies

Smoking Cessation Clinical Trial

Official title:

Efficacy and Cost of State Quitline Policies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366977
• Other study ID #: 1 RO1-CA86242-1
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2006
• Last updated: April 28, 2011
• Start date: June 2000
• Est. completion date: January 2005

Study information

• Verified date: April 2011
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cost-effectiveness
• Smoking Cessation
• Tobacco Use Cessation

Intervention

Behavioral:
• Multi-session telephone counseling

Drug:
• NRT patches

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Department of Human Services, Oregon, Group Health Cooperative, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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* Note: There are 56 references in all — Click here to view all references

Outcome

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.