Clinical trial NCT02896400: Optimizing Tobacco Dependence Treatment in the Emergency Department
Official title: Optimizing Tobacco Dependence Treatment in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2016-09-12
Enrollment: 1056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tobacco Abstinence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale School of Medicine, Department of Emergency Medicine
name: Steven L Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernstein SL, Dziura J, Weiss J, Miller T, Vickerman KA, Grau LE, Pantalon MV, Abroms L, Collins LM, Toll B. Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy. Contemp Clin Trials. 2018 Mar;66:1-8. doi: 10.1016/j.cct.2017.12.016. Epub 2017 Dec 27.