Comparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,365
- 试验地点
- 1
- 主要终点
- Proportion of smokers who engage in treatment with the Quitline or text messaging service
研究概览
简要总结
The investigators propose a Type I hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of Quitlines and text messaging at two VA sites. Specifically, the investigators will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. The investigators will randomly assign teams to either an opt-out or opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.
详细描述
This project is a Type 1 hybrid effectiveness/implementation study to evaluate two population-based approaches for increasing use of specific evidence-based approaches for behavioral tobacco dependence treatment, Quitlines and text messaging, at the Manhattan and Brooklyn campuses of the VA New York Harbor Healthcare System (NYHHS). The project will test the default bias, examining whether an opt-out approach to referral is more effective than an opt-in approach. Researchers will randomly assign clinical care teams at each VA campus to either an opt-out or an opt-in approach to referring smokers to treatment. In the opt-out approach, the default is that everyone is referred to treatment unless they actively choose not to be. In the opt-in approach, people are offered treatment but must actively choose to enroll in it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Survey Cohort -- Have been seen by an NA on the PACT team in the past 12 months at the Manhattan or Brooklyn VA campus AND Current smoker
- •Nursing Assistants/Registered Nurses -- Work on a PACT at the Manhattan or Brooklyn VA campus
- •Administrative Cohort -- Have been seen by a PACT team at the Manhattan or Brooklyn VA campus AND Current smoker
- •Patient Post-Visit Survey Population -- Had a visit with an NA/RN included in the study AND Current smoker
排除标准
- •Survey Cohort -- Non-English speaking
- •Nursing Assistants/Registered Nurses -- None
- •Administrative Cohort -- None
- •Patient Post-Visit Survey Population -- Non-English speaking
研究组 & 干预措施
Opt-in clinical reminder
As the investigators have done previously, the reminder will be self-explanatory, and will walk staff through each step of referral. The reminder will include the following domains: normative advice, referral to treatment, handout
干预措施: Staff training and academic detailing (Behavioral)
Opt-out tobacco treatment
The investigators will directly change the treatment status quo by implementing a clinical reminder that automatically initiates tobacco treatment referral at the time the reminder is activated.
干预措施: Staff training and academic detailing (Behavioral)
结局指标
主要结局
Proportion of smokers who engage in treatment with the Quitline or text messaging service
时间窗: 2-year intervention period
This outcome will be based on data from the Quitline and SmokefreeTXT.
Abstinence at the end of the 2-year intervention period
时间窗: 7-day abstinence
Abstinence will be based on self-report, as is recommended for population-level studies
Proportion of smokers who accept referral to treatment (Quitline or text messaging)
时间窗: 2-year intervention period
This outcome will be based on intervention process data. Note that we will measure both offering and accepting referral, but our outcome will be accepting referral.
次要结局
- Use of smoking cessation medications(2-year intervention period)
- Cost-effectiveness of the two approaches (opt-out vs opt-in)(2-year intervention period)