Metabolism Informed Smoking Treatment in Medicaid and Medicare Patients: The MIST RCT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
研究概览
简要总结
This phase 3 randomized controlled trial will test Metabolism-Informed Smoking Treatment (MIST), a precision approach to smoking treatment that biologically tailors medication selection to nicotine metabolism.
详细描述
This is a randomized controlled trial to compare effects of MIST versus usual care (UC) interventions on the outcomes below.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 18 years or older
- •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
排除标准
- •insufficient time to perform and complete the enrollment process
- •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
研究组 & 干预措施
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.
干预措施: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach. (Behavioral)
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.
干预措施: Nicotine Replacement Therapy (Drug)
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.
干预措施: Varenicline (Drug)
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.
干预措施: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy) (Other)
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.
干预措施: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach. (Behavioral)
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.
干预措施: Nicotine Replacement Therapy (Drug)
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.
干预措施: Varenicline (Drug)
结局指标
主要结局
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
时间窗: 6 months
次要结局
- Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence(12 months)
- Self-reported Medication Adherence Over the Past 7 Days(1, 3 months)
- Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription(Up to 12 months after hospital discharge)
研究者
Hilary Tindle
Investigator
Vanderbilt-Ingram Cancer Center