Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of participants whose self-report of prolonged smoking abstinence is bioverified
研究概览
简要总结
Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans. Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people. The purpose of this study study is to evaluate the effectiveness of an intervention to help Veterans experiencing homelessness stop smoking. The intervention, called Abstinence Reinforcement Therapy + (ART+), includes telehealth-based counseling, smoking cessation aids, and mobile contingency management (mCM). mCM is an intervention in which participants are paid for smoking abstinence. 120 Veterans who smoke cigarettes and are experiencing homelessness will be randomly assigned to receive either ART+ or usual smoking cessation care. The primary outcome to be evaluated is the rate at which Veterans assigned to the ART+ condition report smoking abstinence and have their abstinence verified using salivary testing.
详细描述
Significance to VA: Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans. Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people. While there are numerous challenges to smoking cessation among Veterans experiencing homelessness, four in five homeless smokers report interest in quitting. Innovation and Impact: The investigators recently developed and evaluated the effectiveness of a multi-component intervention called Abstinence Reinforcement Therapy (ART), which combined five sessions of telehealth-based cognitive-behavioral therapy, provision of smoking cessation aids, and four weeks of mobile contingency management (mCM). The investigators have added an additional CM period of eight weeks and opportunities for booster calls and repeated quit attempts, resulting in an intervention called ART+ to improve outcomes over time. The innovative use of web-based platform technology in the current proposal will remove numerous barriers that often prevent smokers experiencing homelessness from accessing high-quality, evidence-based care. There is tremendous inequity in smoking-related outcomes for VEH. The innovative use of mobile health technology in the current proposal will remove numerous barriers that often prevent Veterans who smoke and experience homelessness from accessing high- quality, evidence-based care. Specific Aims: Aim 1: Evaluate the comparative effectiveness of ART+ on bio-verified abstinence outcomes at three-, six-and 12-month follow-ups. The primary endpoint will be bioverified prolonged abstinence at the six-month follow-up. Aim 2: Assess the relative cost-effectiveness of ART+ to VA standard care smoking cessation on quality adjusted life years (QALY). Aim 3: Qualitatively evaluate implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs. Methodology: 120 Veterans experiencing homelessness who smoke cigarettes will be randomly assigned to ART+ or to VA standard smoking cessation care. Self-reported and bioverified abstinence at six months are the primary outcomes. Cost-effectiveness analyses will be performed using QALY as the effectiveness measure. Rapid qualitative analytic methods will be used to evaluate implementation determinants of ART+ following enrollment of all study participants. Participants for the qualitative analysis will include clinicians and clinical support staff who provide care to Veterans experiencing homelessness, designated VA operations partners, and VA Tobacco Treatment Specialists. Purposive sampling will be used to identify potential participants and a structured interview guide based upon domains from the Consolidated Framework for Implementation Research (CFIR) will be administered. The investigators will use rapid qualitative analysis to answer the key qualitative research question: "What determinants will impact implementation of ART+?" The benefit of decreasing tobacco use (Aim 1) among VEH who smoke is tremendous as it will prevent significant morbidity and mortality. Moreover, if ART+ is shown to be cost effective (Aim 2) and implementation determinants are identified (Aim 3), the use of mobile phones as a platform to provide behavioral incentives has the potential to transform the delivery of smoking cessation care. Path to Translation/Implementation: Cost-effectiveness analysis (Aim 2) will help guide implementation decisions. Qualitative evaluation of the implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs (Aim 3) will provide important information on effective implementation of ART+.
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
- •Are homeless
- •Smoke at least 5 cigarettes daily with CO indicating current smoking at time of screening assessment
- •Are willing to try to quit smoking in next 30 days
排除标准
- •Have uncontrolled psychotic symptoms
- •Have active substance dependence other than nicotine (participants in partial remission with at least one month sobriety will be included)
- •Have severely impaired hearing or speech
结局指标
主要结局
Number of participants whose self-report of prolonged smoking abstinence is bioverified
时间窗: 6-month follow-up, about six months after baseline
Prolonged abstinence is defined as 30 days abstinent. For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO \< 5 ppm and/or cotinine \< 6 ng/mL)
次要结局
- Number of participants whose self-report of prolonged smoking abstinence is bioverified(3-month follow-up, about three months after baseline)
- Number of participants whose self-report of prolonged smoking abstinence is bioverified(12-month follow-up, about twelve months after baseline)
- Number of participants who self-report 7-day point prevalence abstinence(3-month follow-up, about three months after baseline)
- Number of participants who self-report 7-day point prevalence abstinence(6-month follow-up, about six months after baseline)
- Number of participants who self-report 7-day point prevalence abstinence(12-month follow-up, about twelve months after baseline)
- Number of participants who self-report 30-day point prevalence abstinence(3-month follow-up, about three months after baseline)
- Number of participants who self-report 30-day point prevalence abstinence(6-month follow-up, about six months after baseline)
- Number of participants who self-report 30-day point prevalence abstinence(12-month follow-up, about twelve months after baseline)
- Number of participants who self-report early continuous abstinence(3-month follow-up, about three months after baseline)
- Incremental Cost-Effectiveness Ratio(12 months post quit, about 12 months after baseline)
- Percentage of carbon monoxide reading completion by participants in ART+ intervention group(3-month follow-up, about three months after baseline)
- Number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in ART+ intervention group(3-month follow-up, about three months after baseline)
- Number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period(3-month follow-up, about three months after baseline)