Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, United States of America; Harvard Medical School, United States of America.
Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, United States of America; Tobacco Research and Treatment Center, Massachusetts General Hospital, United States of America.
J Subst Use Addict Treat. 2023 Feb;145:208930. doi: 10.1016/j.josat.2022.208930. Epub 2023 Jan 6.
Sequential multiple assignment randomized trials (SMART) inform the design of adaptive treatment interventions. We tested the feasibility of a SMART to deliver a stepped-care intervention among primary care patients who smoked daily.
In a 12-week pilot SMART (NCT04020718), we tested the feasibility of recruiting and retaining (>80 %) participants to an adaptive intervention starting with cessation text messages (SMS). The study randomly assigned participants (R1) to assessment of quit status, the tailoring variable, after either 4 or 8 weeks of SMS. The study offered continued SMS alone to those reporting abstinence. Those reporting smoking were randomized (R2) to SMS + mailed NRT or SMS + NRT + brief telephone coaching.
During Jan-March and July-Aug 2020, we enrolled 35 patients (>18 years) from a primary care network in Massachusetts. Two (6 %) of 31 participants reported seven-day point prevalence abstinence at their tailoring variable assessment. The 29 participants who continued to smoke at 4 or 8 weeks were randomized (R2) to SMS + NRT (n = 16) or SMS + NRT + coaching (n = 13). Thirty of 35 participants (86 %) completed 12-weeks; 13 % (2/15) of those in 4-week group and 27 % (4/15) of those in 8-week group had CO < 6 ppm at 12-weeks (p = 0.65). Among 29 participants in R2, one was lost to follow-up, 19 % (3/16) of the SMS + NRT group had CO < 6 ppm vs. 17 % (2/12) of SMS + NRT + coaching (p = 1.00). Treatment satisfaction was high (93 %, 28 of 30 who completed 12-weeks).
A SMART exploring a stepped-care adaptive intervention combining SMS, NRT, and coaching for primary care patients was feasible. Retention and satisfaction were high and quit rates were promising.
序贯多项分配随机试验（SMART）为适应性治疗干预措施的设计提供了信息。我们测试了在每日吸烟的初级保健患者中实施阶梯式护理干预的 SMART 的可行性。
在一项为期 12 周的试点 SMART（NCT04020718）中，我们测试了招募和保留（>80%）参与者参与适应性干预的可行性，该干预措施从停止吸烟短信（SMS）开始。该研究将参与者（R1）随机分配（R1）到 4 或 8 周 SMS 后评估戒烟状态和调整变量。对于报告戒烟的人，只提供继续的 SMS。那些报告吸烟的人被随机分配（R2）接受 SMS+邮寄 NRT 或 SMS+NRT+简短电话辅导。
在 2020 年 1 月至 3 月和 7 月至 8 月期间，我们从马萨诸塞州的一个初级保健网络招募了 35 名（>18 岁）患者。在调整变量评估时，31 名参与者中有 2 名（6%）报告了 7 天点流行率的戒烟率。在 4 或 8 周时继续吸烟的 29 名参与者（R2）被随机分配（R2）接受 SMS+NRT（n=16）或 SMS+NRT+辅导（n=13）。35 名参与者中有 30 名（86%）完成了 12 周的研究；4 周组中有 13%（2/15）和 8 周组中有 27%（4/15）的参与者在 12 周时 CO<6ppm（p=0.65）。在 R2 中的 29 名参与者中，有 1 人失访，SMS+NRT 组中有 19%（3/16）的参与者 CO<6ppm，而 SMS+NRT+辅导组有 17%（2/12）（p=1.00）。治疗满意度很高（93%，30 名完成 12 周研究的参与者中的 28 名）。
一项探索结合 SMS、NRT 和辅导的针对初级保健患者的阶梯式护理适应性干预措施的 SMART 是可行的。保留率和满意度高，戒烟率有希望。
