Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA; Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA.
Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.
Contemp Clin Trials. 2019 May;80:48-54. doi: 10.1016/j.cct.2019.03.006. Epub 2019 Mar 25.
Most smokers see a physician each year, but few use any assistance when they try to quit. Text messaging programs improve smoking cessation in community and school settings; however, their efficacy in a primary care setting is unclear. The current trial assesses the feasibility and preliminary clinical outcomes of text messaging and mailed nicotine replacement therapy (NRT) among smokers in primary care.
In this single-center pilot randomized trial, eligible smokers in primary care are offered brief advice by phone and randomly assigned to one of four interventions: (1) Brief advice only, (2) text messages targeted to primary care patients and tailored to quit readiness, (3) a 2-week supply of nicotine patches and/or lozenges (NRT), and (4) both text messaging and NRT. Randomization is stratified by practice and intention to quit. The text messages (up to 5/day) encourage those not ready to quit to practice a quit attempt, assist those with a quit date through a quit attempt, and promote NRT use. The 2-week supply of NRT is mailed to patients' homes.
Feasibility outcomes include recruitment rates, study retention, and treatment adherence. Clinical outcomes are assessed at 1, 2, 6, and 12-weeks post-enrollment. The primary outcome is ≥1self-reported quit attempt(s). Secondary clinical outcomes include self-reported past 7- and 30-day abstinence, days not smoked, NRT adherence, and exhaled carbon monoxide.
This pilot assesses text messaging plus NRT, as a proactively offered intervention for smoking cessation support in smokers receiving primary care and will inform full-scale randomized trial planning.
ClinicalTrials.govNCT03174158.
大多数吸烟者每年都会看医生，但很少有人在尝试戒烟时寻求任何帮助。短信程序在社区和学校环境中提高了戒烟成功率；然而，它们在初级保健环境中的效果尚不清楚。目前的试验评估了短信程序和邮寄尼古丁替代疗法（NRT）在初级保健中的吸烟者中的可行性和初步临床结果。
在这项单中心试点随机试验中，初级保健中的合格吸烟者通过电话获得简短建议，并随机分配到以下四个干预组之一：（1）仅接受简短建议，（2）针对初级保健患者并根据戒烟准备情况定制的短信，（3）提供两周的尼古丁贴片和/或口含尼古丁糖（NRT），（4）短信和 NRT 都提供。随机化按实践和戒烟意图分层。这些短信（每天最多 5 条）鼓励那些还没准备好戒烟的人尝试戒烟，帮助那些有戒烟日期的人通过戒烟尝试，并促进 NRT 的使用。两周的 NRT 供应邮寄到患者家中。
可行性结果包括招募率、研究保留率和治疗依从性。临床结果在登记后 1、2、6 和 12 周进行评估。主要结果是≥1 次自我报告的戒烟尝试。次要临床结果包括自我报告的过去 7 天和 30 天的戒烟率、未吸烟天数、NRT 依从性和呼出的一氧化碳量。
这项试点评估了短信程序和 NRT 联合应用，作为一种主动提供的干预措施，为接受初级保健的吸烟者提供戒烟支持，并将为全面的随机试验规划提供信息。
ClinicalTrials.govNCT03174158。
