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自动智能手机移动康复支持及电话持续护理在酒精使用障碍治疗中的作用:一项随机对照试验的研究方案

Effects of automated smartphone mobile recovery support and telephone continuing care in the treatment of alcohol use disorder: study protocol for a randomized controlled trial.

作者信息

McKay James R, Gustafson David H, Ivey Megan, McTavish Fiona, Pe-Romashko Klaren, Curtis Brenda, Oslin David A, Polsky Daniel, Quanbeck Andrew, Lynch Kevin G

机构信息

Center on Continuum of Care in Addictions, Perelman School of Medicine, University of Pennsylvania, Philadelphia VAMC, Philadelphia, PA, 19104, USA.

Center for Health Enhancement System Studies, University of Wisconsin-Madison, Madison, WI, 53706, USA.

出版信息

Trials. 2018 Jan 30;19(1):82. doi: 10.1186/s13063-018-2466-1.

Abstract

BACKGROUND

New smartphone communication technology provides a novel way to provide personalized continuing care support following alcohol treatment. One such system is the Addiction version of the Comprehensive Health Enhancement Support System (A-CHESS), which provides a range of automated functions that support patients. A-CHESS improved drinking outcomes over standard continuing care when provided to patients leaving inpatient treatment. Effective continuing care can also be delivered via telephone calls with a counselor. Telephone Monitoring and Counseling (TMC) has demonstrated efficacy in two randomized trials with alcohol-dependent patients. A-CHESS and TMC have complementary strengths. A-CHESS provides automated 24/7 recovery support services and frequent assessment of symptoms and status, but does not involve regular contact with a counselor. TMC provides regular and sustained contact with the same counselor, but no ongoing support between calls. The future of continuing care for alcohol use disorders is likely to involve automated mobile technology and counselor contact, but little is known about how best to integrate these services.

METHODS/DESIGN: To address this question, the study will feature a 2 × 2 design (A-CHESS for 12 months [yes/no] × TMC for 12 months [yes/no]), in which 280 alcohol-dependent patients in intensive outpatient programs (IOPs) will be randomized to one of the four conditions and followed for 18 months. We will determine whether adding TMC to A-CHESS produces fewer heavy drinking days than TMC or A-CHESS alone and test for TMC and A-CHESS main effects. We will determine the costs of each of the four conditions and the incremental cost-effectiveness of the three active conditions. Analyses will also examine secondary outcomes, including a biological measure of alcohol use, and hypothesized moderation and mediation effects.

DISCUSSION

The results of the study will yield important information on improving patient alcohol use outcomes by integrating mobile automated recovery support and counselor contact.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02681406 . Registered on 2 September 2016.

摘要

背景

新型智能手机通信技术为酒精治疗后提供个性化持续护理支持提供了一种新方法。其中一个系统是综合健康强化支持系统成瘾版(A-CHESS),它提供一系列支持患者的自动化功能。当提供给住院治疗后出院的患者时,A-CHESS比标准持续护理改善了饮酒结果。有效的持续护理也可以通过与咨询师的电话沟通来提供。电话监测与咨询(TMC)在两项针对酒精依赖患者的随机试验中已证明其有效性。A-CHESS和TMC具有互补优势。A-CHESS提供全天候自动化康复支持服务以及对症状和状态的频繁评估,但不涉及与咨询师的定期联系。TMC提供与同一位咨询师的定期和持续联系,但在通话之间没有持续支持。酒精使用障碍持续护理的未来可能涉及自动化移动技术和咨询师联系,但对于如何最佳整合这些服务知之甚少。

方法/设计:为解决这个问题,该研究将采用2×2设计(12个月的A-CHESS[是/否]×12个月的TMC[是/否]),其中280名强化门诊项目(IOPs)中的酒精依赖患者将被随机分配到四种情况之一,并随访18个月。我们将确定在A-CHESS中添加TMC是否比单独使用TMC或A-CHESS产生更少的重度饮酒天数,并测试TMC和A-CHESS的主要效果。我们将确定四种情况中每种情况的成本以及三种有效情况的增量成本效益。分析还将检查次要结果,包括酒精使用的生物学指标,以及假设的调节和中介效应。

讨论

该研究的结果将产生有关通过整合移动自动化康复支持和咨询师联系来改善患者酒精使用结果的重要信息。

试验注册

ClinicalTrials.gov,NCT02681406。于2016年9月2日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61ea/5791199/8b05412fd8cb/13063_2018_2466_Fig1_HTML.jpg

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