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临床试验/NCT04311983
NCT04311983已完成不适用

Expanding Population-level Interventions to Help More Low-income Smokers Quit

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,973 人开始时间: 2020年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,973
试验地点
1
主要终点
7day Point Prevalence for Smoking

研究概览

简要总结

In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.

详细描述

There is an urgent need to engage more low-income smokers in activities that lead to quitting. The current standard of practice for population-level tobacco treatment is phone-based cessation counseling delivered by state tobacco quitlines. But quitline services are restricted to smokers who are ready to quit in the next 30 days, a criterion met by only 20-30% of low-income smokers. Thus, current population level tobacco treatment has nothing to offer 70-80% of low-income U.S. smokers. Based on extensive preliminary research by our study team, the investigators assert that offering a pre-cessation intervention - Smoke Free Homes - to low-income smokers who are not yet ready to quit will: (1) engage more smokers in using proven interventions; (2) increase their readiness to quit and quit attempts; (3) reduce the number of cigarettes they smoke per day; and (4) increase cessation. These benefits will accrue in addition to reducing exposure to harmful secondhand smoke for non-smokers in the home. In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes). In the latter condition, smokers will be offered cessation counseling first, just like current standard practice, but those who decline will then be offered Smoke Free Homes. At 3-month followup, those in the latter condition who accepted quitline services but did not quit will be offered Smoke Free Homes, and those that accepted Smoke Free Homes but did not quit will be offered quitline services. The effectiveness portion of the Hybrid Type 2 design (Aim 1) will use intent-to-treat analyses to compare group differences at 3- and 6-month follow-up in 7- and 30-day point prevalence abstinence with biochemical verification, as well as 24-hour quit attempts and cigarettes smoked per day. The implementation portion of the Hybrid Type 2 design (Aims 2-3) will measure smokers' acceptance and use of the interventions, as well as cost-effectiveness and cost-benefits of adding Smoke Free Homes to quitline services. With rates of smoking and smoking-related cancers much higher in low-income populations and treatment costs exceeding tens of billions of dollars annually in Medicaid alone, this large-scale practical trial will provide strong evidence with high external validity to answer an important policy question: Will changing the standard practice for population-level treatment of smoking result in increased cessation in low-income populations?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Participants are unaware of the arms and principal investigators are unaware of participant's randomization to study arm

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •English-speaking
  • •Daily smoker
  • •Does not have a full home smoking ban
  • •Recruited from those who called 2-1-1 for themselves and are not in acute crisis

排除标准

  • •Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers

研究组 & 干预措施

Tobacco Quitline only

Active Comparator

Smokers in this study group will be offered their state Tobacco Quitline programs

干预措施: Tobacco Quitline (Behavioral)

Tobacco Quitline plus Smoke Free Homes

Experimental

Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention

干预措施: Tobacco Quitline (Behavioral)

Tobacco Quitline plus Smoke Free Homes

Experimental

Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention

干预措施: Smoke Free Home (Behavioral)

结局指标

主要结局

7day Point Prevalence for Smoking

时间窗: 6 month follow-up

Percentage of participants who have 7 day smoking abstinence

次要结局

  • Proportion of Participants Who Accept the Tobacco Quitline Program(Baseline and 3-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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