Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Cost of State Quitline Policies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00366977
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : May 2, 2011
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Department of Human Services, Oregon
Information provided by:
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Tobacco Use Cessation Cost-effectiveness Behavioral: Multi-session telephone counseling Drug: NRT patches Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4614 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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



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

Secondary Outcome Measures :
  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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
Kaiser Permanente
National Cancer Institute (NCI)
Department of Human Services, Oregon
Investigators
Layout table for investigator information
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
Publications:
Aickin M, Gensler H. An improvement in the reporting of results while adjusting for multiple testing. Am J Pub Health 1996; 86:726-28
Centers for Disease Control and Prevention, National Center for Health Statistics. U.S. Decennial Life Tables for 1989-91. Volume II, State Life Tables Number 38, Oregon. May 1998.
Dobson AJ. An Introduction to Generalized Linear Models. London UK. Chapman & Hall, 1994.
Drummond MF, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. New York: Oxford University Press, 1987.
Erickson P, Wilson R, Shannon I. Years of Healthy Life. Statistical Notes. Centers for Disease Control and Prevention, National Center for Health Statistics 1995; 7:1-14.
Fiore MC, Bailey WC, Cohen SJ, et al Smoking Cessation Clinical Practice Guideline. Rockville MD: U.S. Department of Health and Human Services, 1996. (Public Health Service, Agency for Health Care Policy and Research, Publication No 96-0692.)
Gold ME, Siegel JE, Russell LB, Milton CW, eds. Cost-Effectiveness in Health and Medicine. New York: Oxford University Press, 1996.
Hays JT, Croghan IT, Offord KP, Hurt RD, Schroeder DR, Wolter TD, Nides MA, Davidson M. Over-the-counter 22mg nicotine patch therapy for smoking cessation: Results from randomized, double-blind, placebo-controlled and open label trials. Presented at the meeting of the Society for Research on Nicotine and Tobacco, San Diego, CA, 1999.
Korberly B. An open label multicenter trial to evaluate and compare the efficacy of Nicotrol 15mg as part of an OTC intervention package or as a prescription as an aid in smoking cessation. Presented at the meeting of the Society for Research on Nicotine and Tobacco, San Diego, CA, 1999.
Leischow SJ, Muramoto ML, Cook GN, Merikle EP, Castellini SM, Otte PS. OTC nicotine patch: Effectiveness alone and with brief physician intervention. American Journal of Health Behavior 1999; 23:61-69.
Lichtenstein E, Brown RA. Current trends in the modification of cigarette dependence. In Bellack AS, Hersen M, Kazdin AE (eds.). International Handbook of Behavioral Modification and Therapy. New York: Plenum Press, 1982, 575-611.
Lipscomb J, Weinstein MC, Torrance GW. Time preference. In: Gold MR, Siegel JE, Russell LB, Weinstein MC, eds. Cost-effectiveness in Health and Medicine, Ch. 7.. New York: Oxford University Press, 1996.
Little RJA, Rubin DB. Statistical analysis with missing data. New York: John Wiley & Sons, 1987.
Manning WG, Fryback DG, Weinstein MC. Reflecting uncertainty in cost-effectiveness analysis. In: Gold MR, Siegel JE, Russell LB, Weinstein MC, eds. Cost-effectiveness in Health and Medicine, Ch. 8. New York: Oxford University Press, 1996
Marlatt GA and Gordon JR (Eds). Relapse Prevenion: Maintenance strategies in the treatment of addictive behaviors. New York: Guilford Press, 1985.
McCullagh P, Nelder JA. Generalized Linear Models. London UK: Chapman & Hall, 1986
Miller WR, Rollnick S. Motivational Interviewing: Preparing People to Change Addictive Behavior. New York: The Guilford Press, 1991.
Rollnick S, Heather N, Bell A. Negotiating behaviour change in medical settings: The development of brief motivational interviewing. Journal of Mental Health 1992; 1:25-37.
Shiffman S. Efficacy of nicotine gum and patch under OTC and real-world prescription conditions. Presented at the meeting of the Society for Research on Nicotine and Tobacco, San Diego, CA, 1999.

Layout table for additonal information
Responsible Party: Jeffrey Fellows, PhD, Kaiser Permanente Center for Health Research
ClinicalTrials.gov Identifier: NCT00366977    
Other Study ID Numbers: 1 RO1-CA86242-1
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011
Keywords provided by Kaiser Permanente:
Cessation
Smoking
Quitline
Policies
Counseling