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

Steven L. Bernstein, James Dziura, June Weiss, Ted Miller, Katrina A. Vickerman, Lauretta E. Grau, Michael V. Pantalon, Lorien Abroms, Linda M. Collins, Benjamin Toll

Research output: Contribution to journalArticle

6 Citations (Scopus)

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 3 months, 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.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalContemporary Clinical Trials
Volume66
DOIs
StatePublished - Mar 2018

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Tobacco Use Disorder
Hospital Emergency Service
Hospital Departments
Telephone
Cost-Benefit Analysis
Text Messaging
Motivational Interviewing
Carbon Monoxide
Nicotine
Tobacco
Cause of Death
Therapeutics
Referral and Consultation
Smoking
Clinical Trials
Interviews
Costs and Cost Analysis

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cite this

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. / Tobacco dependence treatment in the emergency department : A randomized trial using the Multiphase Optimization Strategy. In: Contemporary Clinical Trials. 2018 ; Vol. 66. pp. 1-8.
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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 3 months, 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.",
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Bernstein, SL, Dziura, J, Weiss, J, Miller, T, Vickerman, KA, Grau, LE, Pantalon, MV, Abroms, L, Collins, LM & Toll, B 2018, 'Tobacco dependence treatment in the emergency department: A randomized trial using the Multiphase Optimization Strategy', Contemporary Clinical Trials, vol. 66, pp. 1-8. https://doi.org/10.1016/j.cct.2017.12.016

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

In: Contemporary Clinical Trials, Vol. 66, 03.2018, p. 1-8.

Research output: Contribution to journalArticle

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AU - Collins, Linda M.

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