Smoking CessationPhase 3NCT00366977
Efficacy and Cost of State Quitline Policies
A Phase 3 study testing Multi-session telephone counseling and NRT patches in people with Smoking Cessation and Tobacco Use Cessation, run by Kaiser Permanente at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use Cessation, Cost-effectiveness
- What is being tested?
- Multi-session telephone counseling and NRT patches
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,614 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2000to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Health plan benefit includes free multi-session telephone counseling
- Current or planned pregnancy or breast-feeding
- Heart attack within the preceding month.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Oregon Health Division/Center for Disease Prevention Epidemiology
Portland, Oregon, 97232
Free and Clear, Inc.
Seattle, Washington, 98104
About this study
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.
Read the 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:
- 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.
- Conditions
- Smoking Cessation, Tobacco Use Cessation, Cost-effectiveness
- Being tested
- Multi-session telephone counseling, NRT patches
- Keywords
- Cessation, Smoking, Quitline, Policies, Counseling
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-session telephone counselingBehavioural
NRT patchesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startJun 2000
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Department of Human Services, Oregon
- Investigators
- Jack F. Hollis, PhD, Principal investigator, Kaiser Permanente Foundation Hospitals/Center for Health ResearchTimothy A McAfee, MD, Principal investigator, Group Health Center for Health PromotionMichael J Stark, PhD, Principal investigator, Oregon Health Division/Center for Disease Prevention Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366977
- Sponsor's protocol ID
- 1 RO1-CA86242-1
- Other IDs
- 1R01CA086242
- Status last verified
- Apr 2011
- First submitted
- 18 Aug 2006
- Last updated
- 2 May 2011
- Results posted
- No
Publications
Aickin M, Gensler H. Adjusting for multiple testing when reporting research results: the Bonferroni vs Holm methods. Am J Public Health. 1996 May;86(5):726-8. doi: 10.2105/ajph.86.5.726.
PubMed 8629727Centers 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.
Curry SJ, Grothaus LC, McAfee T, Pabiniak C. Use and cost effectiveness of smoking-cessation services under four insurance plans in a health maintenance organization. N Engl J Med. 1998 Sep 3;339(10):673-9. doi: 10.1056/NEJM199809033391006.
PubMed 9725926Curry SJ, McBride C, Grothaus LC, Louie D, Wagner EH. A randomized trial of self-help materials, personalized feedback, and telephone counseling with nonvolunteer smokers. J Consult Clin Psychol. 1995 Dec;63(6):1005-14. doi: 10.1037//0022-006x.63.6.1005.
PubMed 8543703Davidson M, Epstein M, Burt R, Schaefer C, Whitworth G, McDonald A. Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation. Arch Fam Med. 1998 Nov-Dec;7(6):569-74. doi: 10.1001/archfami.7.6.569.
PubMed 9821833Dobson 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. Healthy People 2000 Stat Notes. 1995 Apr;(7):1-15. doi: 10.1037/e583992012-001. No abstract available.
PubMed 11762385Fiore 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.)
Fiore MC, Kenford SL, Jorenby DE, Wetter DW, Smith SS, Baker TB. Two studies of the clinical effectiveness of the nicotine patch with different counseling treatments. Chest. 1994 Feb;105(2):524-33. doi: 10.1378/chest.105.2.524.
PubMed 8306757Fiore MC, Novotny TE, Pierce JP, Giovino GA, Hatziandreu EJ, Newcomb PA, Surawicz TS, Davis RM. Methods used to quit smoking in the United States. Do cessation programs help? JAMA. 1990 May 23-30;263(20):2760-5.
PubMed 2271019Fiscella K, Franks P. Cost-effectiveness of the transdermal nicotine patch as an adjunct to physicians' smoking cessation counseling. JAMA. 1996 Apr 24;275(16):1247-51.
PubMed 8601956Gold ME, Siegel JE, Russell LB, Milton CW, eds. Cost-Effectiveness in Health and Medicine. New York: Oxford University Press, 1996.
Glasgow RE, Mullooly JP, Vogt TM, Stevens VJ, Lichtenstein E, Hollis JF, Lando HA, Severson HH, Pearson KA, Vogt MR. Biochemical validation of smoking status: pros, cons, and data from four low-intensity intervention trials. Addict Behav. 1993 Sep-Oct;18(5):511-27. doi: 10.1016/0306-4603(93)90068-k.
PubMed 8310871Hays JT, Croghan IT, Schroeder DR, Offord KP, Hurt RD, Wolter TD, Nides MA, Davidson M. Over-the-counter nicotine patch therapy for smoking cessation: results from randomized, double-blind, placebo-controlled, and open label trials. Am J Public Health. 1999 Nov;89(11):1701-7. doi: 10.2105/ajph.89.11.1701.
PubMed 10553392
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost of State Quitline Policies
- ClinicalTrials.gov ID
- NCT00366977
- Acronym / sponsor ID
- 1 RO1-CA86242-1
- Conditions
- Smoking Cessation, Tobacco Use Cessation, Cost-effectiveness
- Keywords
- Cessation, Smoking, Quitline, Policies, Counseling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,614 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Department of Human Services, Oregon
- Study start
- Jun 2000
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 22 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- Health plan benefit includes free multi-session telephone counseling
- Current or planned pregnancy or breast-feeding
- Heart attack within the preceding month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-session telephone counseling | Behavioural | – |
| NRT patches | Drug | – |
Primary outcome
Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.
9 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Background: PubMed 8629727Aickin M, Gensler H. Adjusting for multiple testing when reporting research results: the Bonferroni vs Holm methods. Am J Public Health. 1996 May;86(5):726-8. doi: 10.2105/ajph.86.5.726.
- BackgroundCenters 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.
- Background: PubMed 9725926Curry SJ, Grothaus LC, McAfee T, Pabiniak C. Use and cost effectiveness of smoking-cessation services under four insurance plans in a health maintenance organization. N Engl J Med. 1998 Sep 3;339(10):673-9. doi: 10.1056/NEJM199809033391006.
- Background: PubMed 8543703Curry SJ, McBride C, Grothaus LC, Louie D, Wagner EH. A randomized trial of self-help materials, personalized feedback, and telephone counseling with nonvolunteer smokers. J Consult Clin Psychol. 1995 Dec;63(6):1005-14. doi: 10.1037//0022-006x.63.6.1005.
- Background: PubMed 9821833Davidson M, Epstein M, Burt R, Schaefer C, Whitworth G, McDonald A. Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation. Arch Fam Med. 1998 Nov-Dec;7(6):569-74. doi: 10.1001/archfami.7.6.569.
- BackgroundDobson AJ. An Introduction to Generalized Linear Models. London UK. Chapman & Hall, 1994.
- BackgroundDrummond MF, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. New York: Oxford University Press, 1987.
- Background: PubMed 11762385Erickson P, Wilson R, Shannon I. Years of healthy life. Healthy People 2000 Stat Notes. 1995 Apr;(7):1-15. doi: 10.1037/e583992012-001. No abstract available.
- BackgroundFiore 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.)
- Background: PubMed 8306757Fiore MC, Kenford SL, Jorenby DE, Wetter DW, Smith SS, Baker TB. Two studies of the clinical effectiveness of the nicotine patch with different counseling treatments. Chest. 1994 Feb;105(2):524-33. doi: 10.1378/chest.105.2.524.
- Background: PubMed 2271019Fiore MC, Novotny TE, Pierce JP, Giovino GA, Hatziandreu EJ, Newcomb PA, Surawicz TS, Davis RM. Methods used to quit smoking in the United States. Do cessation programs help? JAMA. 1990 May 23-30;263(20):2760-5.
- Background: PubMed 8601956Fiscella K, Franks P. Cost-effectiveness of the transdermal nicotine patch as an adjunct to physicians' smoking cessation counseling. JAMA. 1996 Apr 24;275(16):1247-51.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack F. Hollis, PhD principal investigator
Kaiser Permanente Foundation Hospitals/Center for Health Research
Timothy A McAfee, MD principal investigator
Group Health Center for Health Promotion
Michael J Stark, PhD principal investigator
Oregon Health Division/Center for Disease Prevention Epidemiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multi-session telephone counseling and NRT patches in people with Smoking Cessation and Tobacco Use Cessation, run by Kaiser Permanente at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant self-reported 30 day abstinence from any tobacco at 6 and 12 months, assuming intent to treat.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00366977, which also lists 56 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2011.