Clinical trial NCT00440115: Disease Management for Smoking Cessation
Official title: Disease Management for Smokers in Rural Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: GlaxoSmithKline
First posted: 2007-02-26
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for smoking. The hypotheses are to compare abstinence from cigarettes, the number of quit attempts, and smokers motivation at 24 months between participants receiving high and low intensity disease management and those receiving usual care.

Detailed description: The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for nicotine dependence. In this study, we will recruit 750 smokers from 20 rural, primary care clinics in Kansas. Subjects will be randomly assigned to one of three study arms, each providing 20 months of treatment: C (comparison group), LDM (low-intensity disease management) or HDM (high-intensity disease management). Participants in group C will receive health educational mailings and an offer for free nicotine replacement therapy (six weeks) or bupropion (seven weeks) every 6 months (months 0, 6, 12, and 18). Participants in LDM will receive the same interventions as C plus a low-intensity disease management program that includes a single telephone counseling session using motivational interviewing (MI) at months 0, 6, 12, and 18 to encourage a cessation attempt and also includes coordination of smoking assessments and pharmacotherapy with the patient's physician. HDM participants will receive C plus a high intensity disease management program that includes up to six telephone-based MI counseling sessions at months 0, 6, 12, and 18 to encourage a smoking cessation attempt and to prevent relapse after a quit attempt, as well as coordination of smoking assessments, quit attempts, and pharmacotherapy with the patient's physician.

The primary outcome of the study is 7-day point prevalence abstinence from cigarettes at 2 years after enrollment. Secondary outcomes include: 1) number of quit attempts and 2) progress in stage of change. If successful, this intervention will provide a generalizable model for addressing nicotine dependence that could improve long-term management of smoking in primary care.

Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days
* Speak English
* Their regular physician is a participating physician
* Working home telephone or cellular phone

Exclusion Criteria:

* Women who are pregnant or planning to become pregnant in the next two years
* Plan on moving within two years
* Display signs of dementia or other mental disorders
* Live with a smoker already enrolled

Primary outcomes:
measure: 7-day Point Prevalence Abstinence From Cigarettes
timeFrame: 24 months
Secondary outcomes:
measure: Number of Quit Attempts
timeFrame: 6, 12, 18, 24 months
measure: Progress in Stage of Change
timeFrame: 6, 12, 18, 24 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Edward F. Ellerbeck, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox LS, Wick JA, Nazir N, Cupertino AP, Mussulman LM, Ahluwalia JS, Ellerbeck EF. Predictors of early versus late smoking abstinence within a 24-month disease management program. Nicotine Tob Res. 2011 Mar;13(3):215-20. doi: 10.1093/ntr/ntq227. Epub 2011 Jan 13.
citation: Cupertino AP, Wick JA, Richter KP, Mussulman L, Nazir N, Ellerbeck EF. The impact of repeated cycles of pharmacotherapy on smoking cessation: a longitudinal cohort study. Arch Intern Med. 2009 Nov 9;169(20):1928-30. doi: 10.1001/archinternmed.2009.355.
citation: Ellerbeck EF, Mahnken JD, Cupertino AP, Cox LS, Greiner KA, Mussulman LM, Nazir N, Shireman TI, Resnicow K, Ahluwalia JS. Effect of varying levels of disease management on smoking cessation: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):437-46. doi: 10.7326/0003-4819-150-7-200904070-00003.
citation: Cox LS, Cupertino AP, Mussulman LM, Nazir N, Greiner KA, Mahnken JD, Ahluwalia JS, Ellerbeck EF. Design and baseline characteristics from the KAN-QUIT disease management intervention for rural smokers in primary care. Prev Med. 2008 Aug;47(2):200-5. doi: 10.1016/j.ypmed.2008.04.013. Epub 2008 May 3.
citation: Berg CJ, Sanderson Cox L, Mahnken JD, Greiner KA, Ellerbeck EF. Correlates of self-efficacy among rural smokers. J Health Psychol. 2008 Apr;13(3):416-21. doi: 10.1177/1359105307088144.
citation: Hutcheson TD, Greiner KA, Ellerbeck EF, Jeffries SK, Mussulman LM, Casey GN. Understanding smoking cessation in rural communities. J Rural Health. 2008 Spring;24(2):116-24. doi: 10.1111/j.1748-0361.2008.00147.x.
citation: Cupertino PA, Richter KP, Cox LS, Nazir N, Greiner AK, Ahluwalia JS, Ellerbeck EF. Smoking cessation pharmacotherapy preferences in rural primary care. Nicotine Tob Res. 2008 Feb;10(2):301-7. doi: 10.1080/14622200701825817.
citation: Cupertino AP, Mahnken JD, Richter K, Cox LS, Casey G, Resnicow K, Ellerbeck EF. Long-term engagement in smoking cessation counseling among rural smokers. J Health Care Poor Underserved. 2007 Nov;18(4 Suppl):39-51. doi: 10.1353/hpu.2007.0117.
citation: Berg CJ, Cox LS, Nazir N, Mussulman LM, Ahluwalia JS, Ellerbeck EF. Correlates of home smoking restrictions among rural smokers. Nicotine Tob Res. 2006 Jun;8(3):353-60. doi: 10.1080/14622200600670132.
citation: Yeh HW, Ellerbeck EF, Mahnken JD. Simultaneous evaluation of abstinence and relapse using a Markov chain model in smokers enrolled in a two-year randomized trial. BMC Med Res Methodol. 2012 Jul 7;12:95. doi: 10.1186/1471-2288-12-95.