Centralized Disease Management for Rural Hospitalized Smokers
The proposed study will use a randomized clinical trial design to examine the effectiveness
of centralized disease management (CDM) versus counseling alone (C) for smoking cessation.
Hospitalized smokers in 30 rural critical access hospitals will be randomly assigned to
either CDM (n=303) or C (n=303). Participants in both arms of the study will receive
in-hospital smoking cessation counseling via telephone followed by 4 outpatient
telephone-based counseling calls. The content and timing of these counseling calls are
designed to emulate models of smoking cessation counseling that have been previously shown
to be effective for hospitalized smokers. For recipients assigned to CDM, the counseling
will be streamlined to allow time on the calls for specific disease management
interventions, including screening for contraindications to pharmacotherapy and linking
medication choices to the smoker's insurance coverage. After completing calls with CDM
participants, the Tobacco Treatment Specialists will coordinate therapy with the patient's
health care providers by providing them with brief consultation reports, prepared order
sheets for inpatient treatment, and outpatient prescription requests. Six months
postdischarge, participants in both groups will be contacted again, and persistent or
relapsed smokers will be offered another cycle of the C or CDM intervention.
Assessments will be conducted at baseline and at months 3, 6, and 12. The primary outcome
of interest will be biochemically verified 7-day point prevalence abstinence at 12 months.
Secondary endpoints include number of quit attempts and number of cigarettes smoked (among
continuing smokers), pharmacotherapy utilization, duration of pharmacotherapy utilization,
and the extent of discussions with the healthcare provider. We will also examine the
marginal cost-effectiveness of the intervention.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
7-day point prevalence abstinence from cigarettes
Edward Ellerbeck, MD, MPH
University of Kansas
United States: Institutional Review Board
5 R01 CA101963-07
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|