This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.
PRIMARY OBJECTIVE: I. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening. SECONDARY OBJECTIVES: I. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare \& Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit. II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches. GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit. After completion of study, participants are followed up at 1, 8, and 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
358
Receive usual care counseling
Given nicotine patches
Ancillary studies
Ancillary studies
Receive counseling over the phone
University of Texas Medical Branch
Galveston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Smoking abstinence Questionnairre
Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)
Time frame: Up to 12 weeks
Lung Cancer Screening 12 items version
Knowledge of lung cancer screening and benefits of smoking cessation
Time frame: Up to 12 weeks
Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study
Assessment of the reach of the intervention
Time frame: Up to 12 weeks
Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al).
Assessment of the feasibility of implementing the intervention
Time frame: Up to 12 weeks
Fidelity checklist (11 items)
Assessment of the feasibility of implementing the intervention
Time frame: Up to 12 weeks
EuroQoL-5 dimensions
Standardized measure of health-related quality of life used to generate patient utilities (will report lower decisional conflict, greater decision preparation, greater intention to stop smoking, and be more likely to make an attempt to stop smoking.)
Time frame: Up to 12 weeks
Costs of implementing any smoking cessation plus shared decision making intervention
Costs of personnel, hardware, and delivering materials to participants
Time frame: Up to 12 weeks
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