University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT01063972
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Centralized Disease Management (CDM) arm will receive smoking cessation counseling with coordination of pharmacotherapy with their insurance coverage and their health care provider
Counseling (C) arm will receive counseling without the care coordination services.
Time frame: 12 months
Participant-reported 7-day point prevalence abstinence from cigarettes, validated by salivary cotinine (< 15ng/ml) or proxy. Participants who did not respond to the survey were considered current smokers.
Time frame: 3 months
7-day point prevalence abstinence at 3 months, self-reported. Participants who did not respond were considered smokers.
Time frame: 6 months
7-day point prevalence abstinence at 6 months, self-reported. Participants who did not respond were considered smokers.
Time frame: 12 months
7-day point prevalence abstinence at 12 months, self-reported. Participants who did not respond were considered smokers.
Time frame: 6 months
Time frame: 12 months
Edward Ellerbeck, MD, MPH
Other
Centralized Disease Management for Rural Hospitalized Smokers
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