Optimizing Tobacco Dependence Treatment in the Emergency Department
- Conditions
- Tobacco Use Disorder
- Interventions
- Other: SmokefreeText (Text)Behavioral: Brief Negotiated Interview (BNI)Drug: Nicotine replacement therapy (NRT)Other: CT Smokers Quitline (QL)
- Registration Number
- NCT02896400
- Lead Sponsor
- Yale University
- Brief Summary
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.
- Detailed Description
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.
Our associated hypotheses are:
1. At 3 months, at least 1 intervention component will yield a biochemically verified tobacco abstinence rate at least 5% greater than in the control condition. Carbon monoxide breath test will be used for biochemical verification.
2. At 3 months, at least 1 intervention will be cost-effective, using a societal perspective.
3. At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1056
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description BNI+NRT+QL+Text Nicotine replacement therapy (NRT) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) BNI+NRT Nicotine replacement therapy (NRT) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply NRT+Text Nicotine replacement therapy (NRT) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) Text only SmokefreeText (Text) Registration in SmokefreeText (Text) BNI+NRT+QL+Text Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) BNI+NRT Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply BNI+QL+Text CT Smokers Quitline (QL) Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) BNI+QL CT Smokers Quitline (QL) Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) BNI+NRT+QL+Text SmokefreeText (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) BNI+NRT+QL Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) BNI+NRT+Text Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) BNI+Text Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text) NRT only Nicotine replacement therapy (NRT) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply BNI+NRT+QL+Text CT Smokers Quitline (QL) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) BNI+NRT+QL CT Smokers Quitline (QL) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) NRT+QL+Text SmokefreeText (Text) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) QL+Text SmokefreeText (Text) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) QL only CT Smokers Quitline (QL) Referral to CT Smokers Quitline (QL) BNI+Text SmokefreeText (Text) Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text) NRT+QL+Text Nicotine replacement therapy (NRT) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) NRT+Text SmokefreeText (Text) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) QL+Text CT Smokers Quitline (QL) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) BNI+NRT+QL Nicotine replacement therapy (NRT) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) BNI+NRT+Text Nicotine replacement therapy (NRT) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) BNI+NRT+Text SmokefreeText (Text) Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) BNI+QL+Text Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) BNI+QL+Text SmokefreeText (Text) Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) BNI+QL Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) BNI only Brief Negotiated Interview (BNI) Brief Negotiated Interview (BNI) NRT+QL+Text CT Smokers Quitline (QL) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) NRT+QL Nicotine replacement therapy (NRT) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) NRT+QL CT Smokers Quitline (QL) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)
- Primary Outcome Measures
Name Time Method Tobacco Abstinence 3 months Abstinence self reported and verified by exhaled carbon monoxide
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States