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Contemp Clin Trials. 2018 Mar;66:1-8. doi: 10.1016/j.cct.2017.12.016. Epub 2017 Dec 27.

Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy.

Author information

1
Department of Emergency Medicine, Yale School of Medicine, United States; Department of Health Policy, Yale School of Public Health, United States; Yale Cancer Center, New Haven, CT, United States. Electronic address: Steven.bernstein@yale.edu.
2
Department of Emergency Medicine, Yale School of Medicine, United States; Department of Health Policy, Yale School of Public Health, United States.
3
Department of Emergency Medicine, Yale School of Medicine, United States.
4
Pacific Institute of Research and Evaluation, Calverton, MD, United States.
5
Alere Wellbeing, Seattle, WA, United States.
6
Department of Health Policy, Yale School of Public Health, United States.
7
Department of Prevention and Community Health, Milken Institute School of Public Health at George Washington University, United States.
8
The Methodology Center and Department of Human Development and Family Studies, Pennsylvania State University, College Station, PA, United States.
9
Yale Cancer Center, New Haven, CT, United States; Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, United States.

Abstract

BACKGROUND:

Tobacco dependence remains the leading preventable cause of death in the developed world. Smokers are disproportionately from lower socioeconomic groups, and may use the hospital emergency department (ED) as an important source of care. A recent clinical trial demonstrated the efficacy of a multicomponent intervention to help smokers quit, but the independent contributions of those components is unknown.

METHODS:

This is a full-factorial (16-arm) randomized trial in a busy hospital ED of 4 tobacco dependence interventions: brief motivational interviewing, nicotine replacement therapy, referral to a telephone quitline, and a texting program. The trial utilizes the Multiphase Optimization Strategy (MOST) and a novel mixed methods analytic design to assess clinical efficacy, cost effectiveness, and qualitative participant feedback. The primary endpoint is tobacco abstinence at 3months, verified by participants' exhaled carbon monoxide.

RESULTS:

Study enrollment began in February 2017. As of April 2017, 52 of 1056 planned participants (4.9%) were enrolled. Telephone-based semi-structured participant interviews and in-person biochemical verification of smoking abstinence are completed at the 3-month follow-up. Efficacy and cost effectiveness analyses will be conducted after follow-up is completed.

DISCUSSION:

The goal of this study is to identify a clinically efficacious, cost-effective intervention package for the initial treatment of tobacco dependence in ED patients. The efficacy of this combination can then be tested in a subsequent confirmatory trial. Our approach incorporates qualitative feedback from study participants in evaluating which intervention components will be tested in the future trial.

TRIAL REGISTRATION:

Trial (NCT02896400) registered in ClinicalTrials.gov on September 6, 2016.

KEYWORDS:

Emergency department; Mixed methods; Smoking cessation; Tobacco dependence treatment

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