This phase III trial compares the effect of a metabolism informed smoking treatment (MIST) to standard therapy to help Medicaid and Medicare patients quit smoking. Quitting smoking can help prevent smoking-related diseases like cancer and heart disease and can help patients live longer. MIST includes a free screening blood test to show how fast the body breaks down nicotine in order to help people quit smoking. The screening test is the first step to a study that may help doctors choose the best medication to quit smoking.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04590404.
PRIMARY OBJECTIVES:
I. Will compare the effects of MIST versus (vs.) usual care (UC) on:
Ia. Abstinence as defined by biochemically-verified self-reported 7-day point prevalence abstinence at 6 m (1 degree study outcome) and 12 m (2 degree outcome).
Ib. Implementation in clinical practice as reflected by: (2a) Patient’s self-reported medication adherence at 1, 3 m; (2b) Primary care physician (PCP) prescription for smoking cessation medication any time after study enrollment, controlling for participant’s abstinence; and (2c) whether the prescription is matched to nicotine metabolite ratio (NMR).
Ic. Healthcare composite outcome (exploratory) comprised of healthcare utilization visits (emergency room [ER] & hospitalizations) and mortality (all-cause and cause-specific) ascertained via the Vanderbilt University Medical Center (VUMC) electronic health record (EHR), Centers for Medicare and Medicaid (CMS) databases, state vital records, and Tennessee Hospital Discharge Data System (TN HDDS).
OUTLINE:
Patients undergo collection of blood samples for NMR testing. Patients are randomized to 1 of 2 arms.
ARM I (MIST): Patients receive a handout containing information on the NMR result and recommended medication. Patients who have been discharged before a valid NMR result is received may be contacted to notify them of their randomization stats and initiate post-randomization procedures including facilitation of smoking cessation medication.
ARM II (USUAL CARE): Patients receive usual care.
After completion of study intervention, patients are followed up at 1, 3, 6, and 12 months.
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorHilary A. Tindle