Treatment of E-Cigarette Use Among Hospitalized Adolescents and Young Adults: A protocol for intervention development and evaluation of preliminary efficacy and implementation outcomes in a randomized controlled trial

Abstract Background Pediatric hospitalization represents a valuable opportunity to identify and treat e-cigarette use among adolescents and young adults (AYAs). Knowledge on how best to provide this care is lacking. We aim to fill this gap by developing an e-cigarette use intervention and evaluating preliminary efficacy and implementation outcomes among hospitalized AYAs. Methods We will enroll 144 AYAs (14-21 years) admitted to a pediatric hospital who report past 30-day e-cigarette use and randomize 2:1 to intervention or control arms. We will develop and iteratively refine an evidence-based intervention that includes education, motivational interviewing, and quit planning by a health educator trained in tobacco and e-cigarette cessation and nicotine replacement therapy prescription if indicated. Control arm participants will receive brief advice and a quit program resource handout. We will assess demographics, e-cigarette use behaviors, nicotine dependence, motivation and confidence to quit using a self-report survey at baseline and post-intervention. Our primary outcome is self-reported 30-day point prevalence e-cigarette abstinence at 3-month follow-up. Our secondary implementation outcomes are feasibility (intervention duration, interruptions), acceptability (Likert scale items, participant enrollment, intervention completion rates) and fidelity (review and fidelity scoring of intervention audio-recordings). We will use a generalized linear model assuming an underlying binomial distribution and logit link function to assess our primary outcome (past 30-day abstinence). Motivation and confidence to quit will be analyzed using a repeated measures analysis of variance. Chi-square (categorical variables) and Wilcoxon Rank Sum (continuous variables) tests will be used to assess for differences between groups. Discussion Given the increasing prevalence of e-cigarette use and related adverse health outcomes, proven e-cigarette use interventions for youth are critically needed. Our study will be among the first to develop and evaluate an e-cigarette use intervention for youth in the pediatric hospital. We will assess preliminary efficacy (i.e., e-cigarette abstinence at 3 month follow-up) and secondary implementation outcomes (i.e., feasibility, acceptability, fidelity). These findings will inform a larger randomized controlled trial to further assess efficacy and implementation with the potential to reach a population at increased risk for poor outcomes. Trial Registration NCT05936099; registered on June 30th, 2023