Conditions: Smoking Cessation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 750
Healthy volunteers: yes

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.

Arms:
arm 1: High intensity disease management, free nicotine replacement therapy or bupropion arm 2: Low intensity disease management, free nicotine replacement therapy or bupropion arm 3: Comparison group, free nicotine replacement therapy or bupropion

Interventions: intervention 1: High intensity disease management intervention 2: Low intensity disease management intervention 3: Comparison group intervention 4: Bupropion
Intervention descriptions: intervention 1: Health education mailings, 6 motivation interviews/counseling intervention 2: Health education mailings, one motivation interview/counseling intervention 3: Health education mailings intervention 4: Buproprion or Nicotine Replacement Therapy

Protocol document: