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

• Published in: Contemporary clinical trials Vol. 66; pp. 1 - 8
• Main Authors: Bernstein, Steven L., Dziura, James, Weiss, June, Miller, Ted, Vickerman, Katrina A., Grau, Lauretta E., Pantalon, Michael V., Abroms, Lorien, Collins, Linda M., Toll, Benjamin
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-03-2018
• Subjects: Adult; Cost-Benefit Analysis; Emergency department; Emergency Service, Hospital; Female; Hotlines - methods; Humans; Male; Middle Aged; Mixed methods; Motivational Interviewing - methods; Nicotine Chewing Gum; Qualitative Research; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; Referral and Consultation; Smoking cessation; Smoking Cessation - methods; Smoking Cessation Agents - therapeutic use; Text Messaging; Tobacco dependence treatment; Tobacco Use Cessation Devices; Tobacco Use Disorder - therapy; Transdermal Patch; Treatment Outcome; United States; United States; Smoking cessation; Tobacco dependence treatment; Emergency department; Mixed methods
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2017.12.016

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.
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.
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.
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.