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一项针对参加雇主和健康计划赞助戒烟热线的近期戒烟者预防复吸的随机对照试验。

A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines.

作者信息

McDaniel Anna M, Vickerman Katrina A, Stump Timothy E, Monahan Patrick O, Fellows Jeffrey L, Weaver Michael T, Carlini Beatriz H, Champion Victoria L, Zbikowski Susan M

机构信息

College of Nursing, University of Florida, Gainesville, Florida, USA.

Alere Wellbeing, Seattle, Washington, USA.

出版信息

BMJ Open. 2015 Jun 29;5(6):e007260. doi: 10.1136/bmjopen-2014-007260.

DOI:10.1136/bmjopen-2014-007260
PMID:26124508
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4486943/
Abstract

OBJECTIVE

To test adding an interactive voice response (IVR)-supported protocol to standard quitline treatment to prevent relapse among recently quit smokers.

DESIGN

Parallel randomised controlled trial with three arms: standard quitline, standard plus technology enhanced quitline with 10 risk assessments (TEQ-10), standard plus 20 TEQ assessments (TEQ-20).

SETTING

Quit For Life (QFL) programme.

PARTICIPANTS

1785 QFL enrolees through 19 employers or health plans who were 24+ h quit.

INTERVENTIONS

QFL is a 5-call telephone-based cessation programme including medications and web-based support. TEQ interventions included 10 or 20 IVR-delivered relapse risk assessments over 8 weeks with automated transfer to counselling for those at risk.

MAIN OUTCOME MEASURES

Self-reported 7-day and 30-day abstinence assessed at 6-month and 12-month post-enrolment (response rates: 61% and 59%, respectively). Missing data were imputed.

RESULTS

1785 were randomised (standard n=592, TEQ-10 n=602, TEQ-20 n=591). Multiple imputation-derived, intent-to-treat 30-day quit rates (95% CI) at 6 months were 59.4% (53.7% to 63.8%) for standard, 62.3% (57.7% to 66.9%) for TEQ-10, 59.4% (53.7% to 65.1%) for TEQ-20 and 30-day quit rates at 12 months were 61.2% (55.6% to 66.8%) for standard, 60.6% (56.0% to 65.2%) for TEQ-10, 54.9% (49.0% to 60.9%) for TEQ-20. There were no significant differences in quit rates. 73.3% of TEQ participants were identified as at-risk by IVR assessments; on average, participants completed 0.41 IVR-transferred counselling calls. Positive risk assessments identified participants less likely (OR=0.56, 95% CI 0.42 to 0.76) to be abstinent at 6 months.

CONCLUSIONS

Standard treatment was highly effective, with 61% remaining abstinent at 12 months using multiple imputation intent-to-treat (intent-to-treat missing=smoking quit rate: 38%). TEQ assessments identified quitters at risk for relapse. However, adding IVR-transferred counselling did not yield higher quit rates. Research is needed to determine if alternative designs can improve outcomes.

TRIAL REGISTRATION NUMBER

NCT00888992.

摘要

目的

测试在标准戒烟热线治疗中添加交互式语音应答(IVR)支持的方案,以防止近期戒烟者复发。

设计

平行随机对照试验,分为三组:标准戒烟热线、标准加10次风险评估的技术增强戒烟热线(TEQ-10)、标准加20次TEQ评估(TEQ-20)。

设置

终身戒烟(QFL)项目。

参与者

通过19个雇主或健康计划招募的1785名QFL参与者,他们已戒烟24小时以上。

干预措施

QFL是一个基于电话的5次呼叫戒烟项目,包括药物治疗和基于网络的支持。TEQ干预措施包括在8周内通过IVR进行10次或20次复发风险评估,并将有风险的人自动转介到咨询服务。

主要结局指标

在入组后6个月和12个月评估自我报告的7天和30天戒烟情况(应答率分别为61%和59%)。缺失数据进行了插补。

结果

1785人被随机分组(标准组n=592,TEQ-10组n=602,TEQ-20组n=591)。多重插补得出的意向性分析6个月时的30天戒烟率(95%CI),标准组为59.4%(53.7%至63.8%),TEQ-10组为62.3%(57.7%至66.9%),TEQ-20组为59.4%(53.7%至65.1%);12个月时的30天戒烟率,标准组为61.2%(55.6%至66.8%),TEQ-10组为60.6%(56.0%至65.2%),TEQ-20组为54.9%(49.0%至60.9%)。戒烟率无显著差异。73.3%的TEQ参与者通过IVR评估被确定为有风险;平均而言,参与者完成了0.41次IVR转介的咨询电话。阳性风险评估表明参与者在6个月时戒烟的可能性较小(OR=0.56,95%CI 0.42至0.76)。

结论

标准治疗非常有效,使用多重插补意向性分析,12个月时61%的人保持戒烟状态(意向性分析缺失=吸烟戒烟率:38%)。TEQ评估识别出有复发风险的戒烟者。然而,添加IVR转介的咨询并没有提高戒烟率。需要进行研究以确定替代设计是否能改善结局。

试验注册号

NCT00888992。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c1d/4486943/8559feecc23c/bmjopen2014007260f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c1d/4486943/5527ddab9748/bmjopen2014007260f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c1d/4486943/8559feecc23c/bmjopen2014007260f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c1d/4486943/5527ddab9748/bmjopen2014007260f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c1d/4486943/8559feecc23c/bmjopen2014007260f02.jpg

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