Optimizing Tobacco Dependence Treatment in the Emergency Department

Study Overview
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Brief Summary
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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
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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: 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. At 3 months, at least 1 intervention will be cost-effective, using a societal perspective. At 3 months, at least 1 intervention will be acceptable and feasible to providers and subjects.

Official Title
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Optimizing Tobacco Dependence Treatment in the Emergency Department

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: Brief Negotiated Interview (BNI)
* Drug: Nicotine replacement therapy (NRT)
* Other: CT Smokers Quitline (QL)
* Other: SmokefreeText (Text)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNI+NRT+QL+Text<br>Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) | Behavioral: Brief Negotiated Interview (BNI)<br>* Brief motivational interview on smoking behavior<br>Drug: Nicotine replacement therapy (NRT)<br>* 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.<br>Other: CT Smokers Quitline (QL)<br>* Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.<br>Other: SmokefreeText (Text)<br>* Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.<br>|
| Experimental: BNI+NRT+QL<br>Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) | Behavioral: Brief Negotiated Interview (BNI)<br>* Brief motivational interview on smoking behavior<br>Drug: Nicotine replacement therapy (NRT)<br>* 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.<br>Other: CT Smokers Quitline (QL)<br>* Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.<br>|
| Experimental: BNI+NRT+Text<br>Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) | Behavioral: Brief Negotiated Interview (BNI)<br>* Brief motivational interview on smoking behavior<br>Drug: Nicotine replacement therapy (NRT)<br>* 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.<br>Other: SmokefreeText (Text)<br>* Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.<br>|
| Experimental: BNI+NRT<br>Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply | Behavioral: Brief Negotiated Interview (BNI)<br>* Brief motivational interview on smoking behavior<br>Drug: Nicotine replacement therapy (NRT)<br>* 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.<br>|
| Experimental: BNI+QL+Text<br>Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) | Behavioral: Brief Negotiated Interview (BNI)<br>* Brief motivational interview on smoking behavior<br>Other: CT Smokers Quitline (QL)<br>* Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.<br>Other: SmokefreeText (Text)<br>* Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.<br>|
| Experimental: BNI+QL<br>Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) | Behavioral: Brief Negotiated Interview (BNI)<br>* Brief motivational interview on smoking behavior<br>Other: CT Smokers Quitline (QL)<br>* Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.<br>|
| Experimental: BNI+Text<br>Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text) | Behavioral: Brief Negotiated Interview (BNI)<br>* Brief motivational interview on smoking behavior<br>Other: SmokefreeText (Text)<br>* Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.<br>|
| Experimental: BNI only<br>Brief Negotiated Interview (BNI) | Behavioral: Brief Negotiated Interview (BNI)<br>* Brief motivational interview on smoking behavior<br>|
| Experimental: NRT+QL+Text<br>Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) | Drug: Nicotine replacement therapy (NRT)<br>* 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.<br>Other: CT Smokers Quitline (QL)<br>* Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.<br>Other: SmokefreeText (Text)<br>* Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.<br>|
| Experimental: NRT+QL<br>Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) | Drug: Nicotine replacement therapy (NRT)<br>* 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.<br>Other: CT Smokers Quitline (QL)<br>* Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.<br>|
| Experimental: NRT+Text<br>Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text) | Drug: Nicotine replacement therapy (NRT)<br>* 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.<br>Other: SmokefreeText (Text)<br>* Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.<br>|
| Experimental: NRT only<br>Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply | Drug: Nicotine replacement therapy (NRT)<br>* 6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.<br>|
| Experimental: QL+Text<br>Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text) | Other: CT Smokers Quitline (QL)<br>* Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.<br>Other: SmokefreeText (Text)<br>* Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.<br>|
| Experimental: QL only<br>Referral to CT Smokers Quitline (QL) | Other: CT Smokers Quitline (QL)<br>* Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.<br>|
| Experimental: Text only<br>Registration in SmokefreeText (Text) | Other: SmokefreeText (Text)<br>* Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.<br>|
| No Intervention: Control<br>Control arm, no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco Abstinence | Abstinence self reported and verified by exhaled carbon monoxide | 3 months |