Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
606 participants
INTERVENTIONAL
2020-11-17
2024-11-22
Brief Summary
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Detailed Description
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Objectives:
* Abstinence as defined by biochemically-verified self-reported 7-day point prevalence abstinence at 6 m (1° study outcome) and 12 m (2° outcome).
* Clinical practice implementation as measured by participant self-reported medication adherence at months 1 and 3, self-reported receipt of prescription for smoking cessation medication after hospital discharge, and whether the prescription was tailored to the NMR result.
Exploratory Objective:
\- Longitudinal assessment of health care utilization visits (ER and hospitalization) for 12 months following hospital discharge.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MIST (Metabolism-Informed Smoking Treatment)
At hospital discharge, participants randomized to the MIST precision care arm will receive a prescription for medication (either varenicline or NRT). Post discharge, participants will receive automated phone calls via TelASK to promote continued engagement. Medication prescriptions will be informed by nicotine metabolism (i.e., NMR result) such that faster metabolizers are prescribed varenicline and slower metabolizers are prescribed NRT.
Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.
Automated calls to assess smoking status, medication use, and additional support for quit attempt.
Nicotine Replacement Therapy
FDA-approved forms of nicotine replacement therapy for smoking cessation.
Varenicline
FDA-approved smoking cessation medication.
Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)
Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.
Usual Care
At hospital discharge, participants randomized to the Usual Care arm will receive a prescription for medication (either varenicline or NRT). Post discharge, participants will receive automated phone calls via TelASK to promote continued engagement. Medication prescription will not be informed by nicotine metabolism.
Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.
Automated calls to assess smoking status, medication use, and additional support for quit attempt.
Nicotine Replacement Therapy
FDA-approved forms of nicotine replacement therapy for smoking cessation.
Varenicline
FDA-approved smoking cessation medication.
Interventions
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Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.
Automated calls to assess smoking status, medication use, and additional support for quit attempt.
Nicotine Replacement Therapy
FDA-approved forms of nicotine replacement therapy for smoking cessation.
Varenicline
FDA-approved smoking cessation medication.
Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)
Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* be enrolled in an insurance plan that supports prescription coverage for smoking cessation medication (such as Medicare part D, Medicaid, or private insurance) to facilitate bedside delivery of medications prior to hospital discharge
* have a regular provider/PCP
* agree to quit or try to quit smoking upon hospital discharge
* be a daily smoker when smoking normally during the month prior to entering the hospital
* be medically eligible to use varenicline
* be medically eligible to use nicotine replacement therapy
* have received discharge medication recommendations from a tobacco counselor
* agree to take smoking cessation medication (i.e., varenicline OR nicotine replacement therapy) home and consider using it
* have a cell phone or landline that can be reached directly (i.e., without transfer)
* have a permanent address where they live and can receive mail
* estimated life expectancy of at least one year or greater
Exclusion Criteria
* barrier to effective communication (including low English proficiency)
* not cognitively able to participate in the study
* too ill, on hospice, or physically unable to participate in the follow-up process
* previously completed the MIST study or is currently enrolled in a quit smoking study that involves a medication-based treatment
* estimated life expectancy of less than one year
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Hilary Tindle
Investigator
Principal Investigators
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Hilary Tindle, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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VICC THO 2046
Identifier Type: -
Identifier Source: org_study_id
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