||5R01CA201873-04 Interpret this number
||Optimizing Tobacco Dependence Treatment in the Emergency Department
Tobacco use remains the leading cause of preventable death in the United States. Smoking is increasingly
a disease of medically underserved populations, including individuals of lower socioeconomic status and those
with behavioral or substance use disorders. Emergency departments (EDs), to which Americans paid 130
million visits in 2013, are excellent clinical settings in which to identify smokers, initiate treatment, and refer for
aftercare. Our previous work has demonstrated the efficacy of a multicomponent intervention in promoting
tobacco abstinence at 3 months. The intervention included a full package of evidence-based treatments,
including initiation of nicotine replacement therapy in the ED, provision of 6 weeks of patches and gum, a brief
motivational interview, active referral to a state smokers' quitline, and a brochure with information on the health
risks of smoking. A subsequent pilot study demonstrated the feasibility and potential efficacy of an intervention
that included short-message-service (SMS) texting to subject cellphones to promote tobacco abstinence. While
efficacious, it is not clear which components of the intervention had the greatest impact, which combinations of
therapy might work best, or which are generalizable to all EDs. In order to design an intervention that is
clinically effective, cost-effective, and practicable, we propose to disentangle the effects of these components
and assemble an intervention that maximizes clinical efficacy, feasibility, and acceptability, given a cost-
effectiveness constraint and findings from qualitative analysis. The methodology we propose using is the
Multiple Optimization Strategy (MOST), a clinical trials design that uses principles adapted from industrial
engineering. We propose an innovative 16-arm full-factorial design in a cohort of 1056 adult smokers in an
urban ED, to test the efficacy of four key components: motivational interviewing, initiation of nicotine
replacement medication, quitline referral, and texting. All subjects will receive a smoking cessation brochure. At
the trial's completion, we will use a novel mixed-methods approach to identify components that were
efficacious within the proposed cost constraint, along with feasibility and acceptability to subjects. We will
assemble components found to be clinically efficacious, cost-effective, and feasible/acceptable into a
multicomponent package for testing in a future randomized clinical trial. Study Aim (1) is to conduct the
factorial experiment; Aim (2) is to analyze trial results to identify the effective components, and Aim (3) is to lay
the groundwork for the subsequent clinical trial testing this multicomponent intervention, versus a control
condition. The multicomponent intervention, once disseminated and implemented, can transform the care of
the tens of millions of smokers who visit U.S. EDs. Our team includes an outstanding array of experts with
deep experience in trial design, including the developer of MOST, emergency department-based investigation,
tobacco dependence treatment, texting, health economics, and qualitative methods.
National medical expenditures by smoking status in American adults: an application of Manning's two-stage model to nationally representative data.
, Miller T.R.
, Ali B.
, Waeher G.
, Bernstein S.L.
BMJ open, 2019-07-16; 9(7), p. e026592.
Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy.
, Dziura J.
, Weiss J.
, Miller T.
, Vickerman K.A.
, Grau L.E.
, Pantalon M.V.
, Abroms L.
, Collins L.M.
, Toll B.
Contemporary clinical trials, 2018 03; 66, p. 1-8.