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Optimizing Tobacco Dependence Treatment in the Emergency Department (NCT02896400)

National Cancer Institute (NCI)
National Institutes of Health (NIH)
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.
  • Behavioral: Brief Negotiated Interview (BNI)
    Brief motivational interview on smoking behavior
    • Drug: Nicotine replacement therapy (NRT)
      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.
      • Other: CT Smokers Quitline (QL)
        Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
        • Other: SmokefreeText (Text)
          Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
          Ages eligible for Study
          18 Years and older
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          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.
          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; (3) active referral to the Connecticut Smokers' Quitline; and (4) enrollment in the SmokefreeTXT short-messaging service (SMS) texting program for mobile phones. 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: BNI, NRT, QL referral, and SMS texting.

          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.

          1 locations

          United States (1)
          • Yale School of Medicine
            recruiting
            New Haven, Connecticut, United States, 06519
          Status:
          recruiting
          Type:
          Interventional
          Phase:
          -
          Start:
          31 December, 2016
          Updated:
          24 January, 2017
          Participants:
          1056
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