Trial Information

Disease Management for Smokers in Rural Primary Care

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.