Smoking Cessation Clinical Trial
Official title:
Centralized Disease Management for Rural Hospitalized Smokers
Our long-term goal is to improve smoking cessation treatment for rural smokers. The objective is to assess the effectiveness of a centralized disease management program for hospitalized smokers that coordinates care across treatment settings and links smokers to existing resources. Our central hypothesis is that Centralized Disease Management (CDM) will increase the use of smoking cessation treatments and lead to greater long term smoking cessation than Counseling alone. Demonstrating the effectiveness of a disease management program and identifying the critical components of such a program will provide a basis for improving the utilization of existing smoking cessation resources while enhancing the treatment of 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.
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