Tobacco Research and Treatment Center, Massachusetts General Hospital, 100 Cambridge St., Suite 1600, Boston, MA, 02114, USA.
Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA.
Trials. 2020 Apr 16;21(1):336. doi: 10.1186/s13063-020-04257-7.
Tobacco smoking remains the leading preventable cause of death in the US. A hospital admission provides smokers with a unique opportunity to stop smoking because it requires temporary tobacco abstinence while illness may enhance motivation to quit. Hospital interventions must continue post-discharge to increase tobacco abstinence long-term, but how best to accomplish this remains unclear. Building on two previous randomized controlled trials, each of which tested smoking cessation interventions that began in hospital and continued after discharge, this trial compares two interventions that provide sustained smoking cessation treatment after hospital discharge with the goal of improving long-term smoking cessation rates among hospitalized smokers.
METHODS/DESIGN: Helping HAND 4 is a three-site randomized controlled trial that compares the effectiveness of two active interventions for producing validated past 7-day tobacco abstinence 6 months after hospital discharge. Smokers who are admitted to three hospitals receive a standard in-hospital smoking intervention, and those who plan to quit smoking after discharge are recruited and randomly assigned to two interventions that begin at discharge, Personalized Tobacco Care Management (PTCM) or Quitline eReferral. Each lasts 3 months. At discharge, PTCM provides 8 weeks of free nicotine replacement (NRT; a participant's choice of patch, gum, lozenge, or a combination) and then proactive smoking cessation support using an automated communication platform and live contact with a tobacco treatment specialist who is based in the health care system. In the eReferral condition, a direct referral is made from the hospital electronic health record to a community-based resource, the state's telephone quitline. The quitline provides up to 8 weeks of free NRT and offers behavioral support via a series of phone calls from a trained coach. Outcomes are assessed at 1, 3, and 6 months after discharge. The study hypothesis is that PTCM will produce higher quit rates than eReferral.
Helping HAND 4 is a pragmatic trial that aims to evaluate interventions in real-world conditions. This project will give hospital systems critical evidence-based tools for meeting National Hospital Quality Measures for tobacco treatment and maximizing their ability to improve cessation rates and overall health for the millions of smokers hospitalized annually in the US.
Prospectively registered prior to start of enrollment at Clinicaltrials.gov, NCT03603496 (July 27, 2018). https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00084MJ&selectaction=Edit&uid=U00002G7&ts=2&cx=ff0oxn.
吸烟仍然是美国可预防死亡的主要原因。住院为吸烟者提供了一个独特的戒烟机会，因为住院期间需要暂时戒烟，而疾病可能会增强戒烟的动机。但要使戒烟成功，需要在出院后继续进行干预，然而目前尚不清楚如何才能最好地做到这一点。本试验在两项先前的随机对照试验的基础上进行，这两项试验都测试了在医院开始并在出院后继续进行的戒烟干预措施，该试验比较了两种在出院后提供持续戒烟治疗的干预措施，以期提高住院吸烟者的长期戒烟率。
方法/设计：HAND4 试验是一项三站点随机对照试验，比较了两种积极干预措施在出院后 6 个月时产生经过验证的过去 7 天内戒烟的效果。入住三家医院的吸烟者接受标准的院内戒烟干预，计划在出院后戒烟的吸烟者被招募并随机分配到两种干预措施中，分别是个性化烟草护理管理（PTCM）或戒烟热线转介。两种干预措施都持续 3 个月。在出院时，PTCM 提供 8 周的免费尼古丁替代治疗（NRT；参与者可选择贴片、口香糖、锭剂或组合），然后使用自动化通信平台和与基于医疗保健系统的烟草治疗专家进行实时联系，提供积极的戒烟支持。在转介条件下，医院电子病历直接转介到社区资源，即该州的电话戒烟热线。戒烟热线提供长达 8 周的免费 NRT，并通过由经过培训的教练进行的一系列电话提供行为支持。在出院后 1、3 和 6 个月评估结果。研究假设是 PTCM 的戒烟率将高于转介。
HAND4 试验是一项实用的试验，旨在评估现实条件下的干预措施。该项目将为医院系统提供重要的基于证据的工具，以满足国家医院质量措施中关于烟草治疗的要求，并最大限度地提高他们改善每年在美国住院的数百万吸烟者的戒烟率和整体健康水平的能力。
在 Clinicaltrials.gov 注册，注册日期为 2018 年 7 月 27 日，编号为 NCT03603496。https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S00084MJ&selectaction=Edit&uid=U00002G7&ts=2&cx=ff0oxn。
