This clinical trial studies how well proactive counseling and nicotine replacement therapy work in changing the default for tobacco treatment in smokers. Proactive counseling and nicotine replacement therapy may provide a model of how to alter and evaluate the impact of health care defaults.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02721082.
OBJECTIVES:
I. To determine the population impact of changing the default for tobacco cessation treatment.
II. To identify long-term impact, mediators of effectiveness, and costs.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (OPT-OUT): Patients will only not receive cessation treatment by “opting out”. Patients receive brief practical counseling and a paper copy of one treatment plan in hospital and are referred to outpatient tobacco treatment counseling. Patients receive up to 4 proactive counseling calls over 15-30 minutes each. Patients ready to quit also receive a 14-day supply of the nicotine patch, nicotine lozenge, nicotine gum, or other nicotine replacement. Patients who are not ready to quit receive motivational counseling. Patients who indicate that they have quit smoking may undergo collection of a saliva sample or a carbon monoxide breath test to verify their quit status.
ARM II (OPT-IN): Patients must first indicate they are ready to quit smoking by “opting in” to receive cessation treatment. Patients who are ready to quit receive counseling, treatment plan, and nicotine replacement medications as in Arm I. Patients who are not ready to quit receive motivational counseling. Patients who indicate that they have quit smoking may undergo collection of a saliva sample or a carbon monoxide breath test to verify their quit status.
After completion of study, patients are followed up at 1 and 6 months.
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorKimber Richter