Optimizing Tobacco Dependence Treatment in the Emergency Department
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,056
- 试验地点
- 1
- 主要终点
- Tobacco Abstinence
研究概览
简要总结
The investigators propose an innovative full-factorial design in a cohort of 1056 adult smokers in an urban emergency department (ED), to test the efficacy of four key intervention components: motivational interviewing, medication, quitline referral, and texting. At the trial's completion, a mixed-methods approach will be used to identify the components that were efficacious within the proposed cost constraint, along with feasibility and acceptability to providers and subjects. The investigators will then assemble an intervention that maximizes efficacy, given a cost-effectiveness constraint and findings from a qualitative analysis.
详细描述
The investigators propose to optimize the identification and treatment of adult smokers seen in a hospital ED. To do this the Multiple Optimization Strategy (MOST) will be employed to develop a multicomponent intervention that will consist of some combination of the following: (1) a Brief Negotiation Interview (BNI, a variant of a motivational interview), delivered by a trained research assistant; (2) provision of 6 weeks of nicotine patches and gum to the research participant, with application of the first patch in the ED (NRT); (3) active referral to the Connecticut Smokers' Quitline (QL); and (4) enrollment in the SmokefreeText a short-messaging service (SMS) texting program for mobile phones (Text). Using MOST principles, the first phase of the study will use a 2x2x2x2 full-factorial design to identify the components most likely to be efficacious in combination. Although the factorial design requires the allocation of participants to 16 different combinations of the 4 components (Table 1), evaluation of each individual component is performed comparing all of those receiving a component to all of those not receiving a component, making this an efficient design. For instance, evaluation of the BNI component will compare those randomized to arms 1 through 8 to those in arms 9 to 16.The second phase will consist of designing and proposing a 2-arm randomized clinical trial comparing the efficacy of the multicomponent intervention package to usual care; this will be conducted in a future application.
The specific aims of this proposed study are:
Aim 1. To conduct a fully powered factorial randomized trial of 1056 adult smokers to test the efficacy of 4 key components of ED-initiated tobacco treatment: Brief Negotiated Interview (BNI), nicotine replacement therapy (NRT), Quitline referral (QL), and SmokeFreeText (Text).
Aim 2. To identify the most efficacious components of our intervention, within fixed constraints of cost effectiveness and feasibility/acceptability to providers and subjects.
Aim 3. To lay the groundwork for a future randomized trial testing the previously identified components, delivered as a package, against a control arm in a new cohort of adult ED smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •18 years or older
- •have smoked >= 100 cigarettes lifetime
- •describe themselves as every or some day smokers
- •smoke at least 5 cigarettes/day
- •own a cellphone with texting capability
- •are able to give written informed consent
排除标准
- •Inability to read or understand English
- •currently receiving formal tobacco dependence treatment
- •life-threatening or unstable medical, surgical, or psychobehavioral condition
- •unable to provide at least one collateral contact
- •live out-of-state
- •leaving the ED against medical advice
- •pregnant (self-report or urine testing), nursing, or trying to conceive.
研究组 & 干预措施
BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: Brief Negotiated Interview (BNI) (Behavioral)
BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: Nicotine replacement therapy (NRT) (Drug)
BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: CT Smokers Quitline (QL) (Other)
BNI+NRT+QL+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: SmokefreeText (Text) (Other)
BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
干预措施: Brief Negotiated Interview (BNI) (Behavioral)
BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
干预措施: Nicotine replacement therapy (NRT) (Drug)
BNI+NRT+QL
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
干预措施: CT Smokers Quitline (QL) (Other)
BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
干预措施: Brief Negotiated Interview (BNI) (Behavioral)
BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
干预措施: Nicotine replacement therapy (NRT) (Drug)
BNI+NRT+Text
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
干预措施: SmokefreeText (Text) (Other)
BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
干预措施: Brief Negotiated Interview (BNI) (Behavioral)
BNI+NRT
Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
干预措施: Nicotine replacement therapy (NRT) (Drug)
BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: Brief Negotiated Interview (BNI) (Behavioral)
BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: CT Smokers Quitline (QL) (Other)
BNI+QL+Text
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: SmokefreeText (Text) (Other)
BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
干预措施: Brief Negotiated Interview (BNI) (Behavioral)
BNI+QL
Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)
干预措施: CT Smokers Quitline (QL) (Other)
BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
干预措施: Brief Negotiated Interview (BNI) (Behavioral)
BNI+Text
Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)
干预措施: SmokefreeText (Text) (Other)
BNI only
Brief Negotiated Interview (BNI)
干预措施: Brief Negotiated Interview (BNI) (Behavioral)
NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: Nicotine replacement therapy (NRT) (Drug)
NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: CT Smokers Quitline (QL) (Other)
NRT+QL+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: SmokefreeText (Text) (Other)
NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
干预措施: Nicotine replacement therapy (NRT) (Drug)
NRT+QL
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
干预措施: CT Smokers Quitline (QL) (Other)
NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
干预措施: Nicotine replacement therapy (NRT) (Drug)
NRT+Text
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)
干预措施: SmokefreeText (Text) (Other)
NRT only
Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply
干预措施: Nicotine replacement therapy (NRT) (Drug)
QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: CT Smokers Quitline (QL) (Other)
QL+Text
Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)
干预措施: SmokefreeText (Text) (Other)
QL only
Referral to CT Smokers Quitline (QL)
干预措施: CT Smokers Quitline (QL) (Other)
Text only
Registration in SmokefreeText (Text)
干预措施: SmokefreeText (Text) (Other)
结局指标
主要结局
Tobacco Abstinence
时间窗: 3 months
Abstinence self reported and verified by exhaled carbon monoxide
次要结局
未报告次要终点