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

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.

Use of Non–Face-to-Face Modalities for Emergency Department Screening, Brief Intervention, and Referral to Treatment (ED-SBIRT) for High-Risk Alcohol Use: A Scoping Review

“…We extracted data from 30 full-text articles published in journals mostly classified as "Substance Abuse" or "Emergency Medicine" publications. In terms of study design, there is an opportunity for ED-SBIRT researchers to move beyond traditional designs (e.g., two-arm RCTs) and explore other study designs (e.g., microrandomized trials 51 ) and approaches (e.g., Multiphase Optimization Strategy [MOST] 52 ). Regarding inclusion criteria, there may be an opportunity to explore ED-SBIRT for high-risk alcohol use among older patients.…”

Simulation and minimization: Technical advances for factorial experiments designed to optimize clinical interventions

“…We adopted a three-stage method to determine the optimal assignment strategy: (1) review literature and define assignment procedures; (2) conduct simulations on a dataset from a previous study, reporting outcomes for each strategy with respect to balance, equivalence, and randomness; (3) review results with research team; determine which method is optimal across all outcomes.…”

“…MOST optimization trials utilize factorial experimental design [3,4,5] because they can test multiple factors (i.e., intervention components) simultaneously, using the same participants while maintaining satisfactory statistical power [6]. For example, a factorial design with two intervention components with two levels each yields four cells (i.e., 2 x 2 = 4), each representing a group of participants assigned to a study condition that receives a unique combination of intervention component levels.…”

The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel

“…Another approach is to evaluate the cost-effectiveness of the intervention, compared to other alternatives [72,73]. The MOST framework can also incorporate constraints on interventions such as cost and dosage limits [74]. These approaches can identify interventions whose costs are justifiable in relation to the health outcomes they produce.…”