Efficacy and Cost of State Quitline Policies

NCT00366977 | Completed Phase 3

• 2 other identifiers: 1 RO1-CA86242-11R01CA086242
• Study Type: interventional
• Target: 4,614
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Smoking Cessation; Tobacco Use Cessation; Cost-effectiveness

Keywords

Cessation; Smoking; Quitline; Policies; Counseling

Outcome Measures

Primary Outcomes (1)

• Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.

Secondary Outcomes (9)

• 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

Interventions

Multi-session telephone counseling BEHAVIORAL

NRT patches DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Health plan benefit includes free multi-session telephone counseling
• Current or planned pregnancy or breast-feeding
• Heart attack within the preceding month.

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator
• Department of Human Services, Oregon: collaborator

Study Sites (3)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Oregon Health Division/Center for Disease Prevention Epidemiology

Portland, Oregon, 97232, United States

Location

Free and Clear, Inc.

Seattle, Washington, 98104, United States

Location

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MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2006
• First Posted: August 22, 2006
• Study Start: June 1, 2000
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: May 2, 2011

Record last verified: 2011-04

Locations

US (3)