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OpenTrials
Completed

NCT Number: NCT00366977

Efficacy and Cost of State Quitline Policies

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaiser Permanente Center for Health Research, Portland, Oregon, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-session telephone counseling

Behavioral

NRT patches

Drug

Primary outcomes

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

Secondary outcomes

  1. Participant self-reported (at 6 and 12 months) any tobacco use by type

  2. amount used per day

  3. stage of change

  4. number of quit attempts

  5. use of health plan and community cessation resources

  6. intervention total cost, cost per participant, and cost per quit

  7. incremental cost effectiveness ratios for each intervention compared to baseline

  8. patterns of pharmacotherapy use

  9. out-of-pocket expenses for cessation activities.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Department of Human Services, Oregon
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Aug 22, 2006
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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