Wooten Shelbie, Catley Delwyn, Miller Melissa K, Wilson Karen, Richter Kimber P, Masonbrink Abbey
Hospital Medicine, Children's Mercy Kansas City, Kansas City, Missouri, USA.
San Diego State University, San Diego, California, USA.
BMJ Open. 2025 Jan 8;15(1):e094323. doi: 10.1136/bmjopen-2024-094323.
Hospitalisation represents an opportunity to identify and treat e-cigarette use among adolescents and young adults (AYAs). Knowledge on how 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 hospitalised AYAs.
We will enrol 144 hospitalised AYAs (14-21 years) who report past 30-day e-cigarette use and randomise 2:1 to intervention or control arms. We will develop an evidence-based intervention that includes education, motivational interviewing, quit planning and nicotine replacement therapy prescription offered confidentially in person during the hospital stay and 4 weekly phone booster sessions. Control participants will receive brief advice and quit programme resources. We will assess self-reported demographics, e-cigarette use behaviours, nicotine dependence, motivation and confidence to quit at baseline and postintervention. Our primary outcome is self-reported 30-day point prevalence e-cigarette abstinence at the 3-month follow-up with biochemical salivary cotinine confirmation. Our secondary implementation outcomes are feasibility, acceptability and fidelity. We will assess our primary outcome using a generalised linear model assuming an underlying binomial distribution and logit link function. X (categorical variables) and Wilcoxon rank-sum (continuous variables) tests will be used to assess differences between groups.
Careful consideration will be given to ethical recruitment and implementation of all elements of the study. Our study protocol and documents will be reviewed and approved by the institutional review board at the affiliated academic institution. Only approved study team members will access participant data, and all data will be managed in accordance with institutional review board and Health Insurance Portability and Accountability Act (HIPAA) requirements. Study results will be disseminated to our public committee, youth research advisory board, to relevant stakeholders and through publication.
NCT05936099; registered on 30 June 2023. Study recruitment and enrolment began in August 2023 and is ongoing.
住院治疗为识别和治疗青少年及青年（AYA）使用电子烟的情况提供了契机。目前尚缺乏如何提供此类护理的相关知识。我们旨在通过开发一种电子烟使用干预措施，并评估住院AYA的初步疗效和实施效果来填补这一空白。
我们将招募144名报告在过去30天内使用过电子烟的住院AYA（14 - 21岁），并按2:1随机分为干预组或对照组。我们将制定一项基于证据的干预措施，包括教育、动机性访谈、戒烟计划以及在住院期间亲自保密提供的尼古丁替代疗法处方，以及4次每周一次的电话强化辅导课程。对照组参与者将获得简短建议和戒烟计划资源。我们将在基线和干预后评估自我报告的人口统计学信息、电子烟使用行为、尼古丁依赖、戒烟动机和信心。我们的主要结局是在3个月随访时自我报告的30天点流行率电子烟戒断情况，并通过生化唾液可替宁确认。我们的次要实施结局是可行性、可接受性和保真度。我们将使用假设潜在二项分布和logit链接函数的广义线性模型评估主要结局。将使用X（分类变量）检验和Wilcoxon秩和检验（连续变量）来评估组间差异。
将仔细考虑研究所有要素的伦理招募和实施。我们的研究方案和文件将由附属学术机构的机构审查委员会进行审查和批准。只有经批准的研究团队成员才能访问参与者数据，并且所有数据将按照机构审查委员会和《健康保险流通与责任法案》（HIPAA）的要求进行管理。研究结果将传播给我们的公共委员会、青年研究咨询委员会、相关利益相关者并通过发表。
NCT05936099；于2023年6月30日注册。研究招募于2023年8月开始，目前正在进行中。
