Adjunctive Medication Management and Contingency Management to enhance adherence to acamprosate for alcohol dependence: the ADAM trial RCT.

IF 3.5 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Kim Donoghue, Sadie Boniface, Eileen Brobbin, Sarah Byford, Rachel Coleman, Simon Coulton, Edward Day, Ranjita Dhital, Anum Farid, Laura Hermann, Amy Jordan, Andreas Kimergård, Maria-Leoni Koutsou, Anne Lingford-Hughes, John Marsden, Joanne Neale, Aimee O'Neill, Thomas Phillips, James Shearer, Julia Sinclair, Joanna Smith, John Strang, John Weinman, Cate Whittlesea, Kideshini Widyaratna, Colin Drummond
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引用次数: 0

Abstract

Background: Acamprosate is an effective and cost-effective medication for alcohol relapse prevention but poor adherence can limit its full benefit. Effective interventions to support adherence to acamprosate are therefore needed.

Objectives: To determine the effectiveness of Medication Management, with and without Contingency Management, compared to Standard Support alone in enhancing adherence to acamprosate and the impact of adherence to acamprosate on abstinence and reduced alcohol consumption.

Design: Multicentre, three-arm, parallel-group, randomised controlled clinical trial.

Setting: Specialist alcohol treatment services in five regions of England (South East London, Central and North West London, Wessex, Yorkshire and Humber and West Midlands).

Participants: Adults (aged 18 years or more), an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, diagnosis of alcohol dependence, abstinent from alcohol at baseline assessment, in receipt of a prescription for acamprosate.

Interventions: (1) Standard Support, (2) Standard Support with adjunctive Medication Management provided by pharmacists via a clinical contact centre (12 sessions over 6 months), (3) Standard Support with adjunctive Medication Management plus Contingency Management that consisted of vouchers (up to £120) to reinforce participation in Medication Management. Consenting participants were randomised in a 2 : 1 : 1 ratio to one of the three groups using a stratified random permuted block method using a remote system. Participants and researchers were not blind to treatment allocation.

Main outcome measures: Primary outcome: self-reported percentage of medication taken in the previous 28 days at 6 months post randomisation. Economic outcome: EuroQol-5 Dimensions, a five-level version, used to calculate quality-adjusted life-years, with costs estimated using the Adult Service Use Schedule.

Results: Of the 1459 potential participants approached, 1019 (70%) were assessed and 739 (73 consented to participate in the study, 372 (50%) were allocated to Standard Support, 182 (25%) to Standard Support with Medication Management and 185 (25%) to Standard Support and Medication Management with Contingency Management. Data were available for 518 (70%) of participants at 6-month follow-up, 255 (68.5%) allocated to Standard Support, 122 (67.0%) to Standard Support and Medication Management and 141 (76.2%) to Standard Support and Medication Management with Contingency Management. The mean difference of per cent adherence to acamprosate was higher for those who received Standard Support and Medication Management with Contingency Management (10.6%, 95% confidence interval 19.6% to 1.6%) compared to Standard Support alone, at the primary end point (6-month follow-up). There was no significant difference in per cent days adherent when comparing Standard Support and Medication Management with Standard Support alone 3.1% (95% confidence interval 12.8% to -6.5%) or comparing Standard Support and Medication Management with Standard Support and Medication Management with Contingency Management 7.9% (95% confidence interval 18.7% to -2.8%). The primary economic analysis at 6 months found that Standard Support and Medication Management with Contingency Management was cost-effective compared to Standard Support alone, achieving small gains in quality-adjusted life-years at a lower cost per participant. Cost-effectiveness was not observed for adjunctive Medication Management compared to Standard Support alone. There were no serious adverse events related to the trial interventions reported.

Limitations: The trial's primary outcome measure changed substantially due to data collection difficulties and therefore relied on a measure of self-reported adherence. A lower than anticipated follow-up rate at 12 months may have lowered the statistical power to detect differences in the secondary analyses, although the primary analysis was not impacted.

Conclusions: Medication Management enhanced with Contingency Management is beneficial to patients for supporting them to take acamprosate.

Future work: Given our findings in relation to Contingency Management enhancing Medication Management adherence, future trials should be developed to explore its effectiveness and cost-effectiveness with other alcohol interventions where there is evidence of poor adherence.

Trial registration: This trial is registered as ISRCTN17083622 https://doi.org/10.1186/ISRCTN17083622.

Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 22. See the NIHR Journals Library website for further project information.

辅助药物管理和应急管理以提高对非草甘膦治疗酒精依赖的依从性:ADAM试验随机对照试验。
背景:草甘膦是一种有效且具有成本效益的预防酒精复发的药物,但依从性差会限制其全部益处。因此,需要采取有效的干预措施来支持对非草甘膦的坚持。目的:确定药物管理(有或没有应急管理)与单独的标准支持相比,在提高对非草甘膦的依从性方面的有效性,以及依从性对禁欲和减少饮酒的影响。设计:多中心、三组、平行组、随机对照临床试验。背景:英格兰五个地区(伦敦东南部、伦敦中部和西北部、威塞克斯郡、约克郡和亨伯郡以及西米德兰兹郡)的专业酒精治疗服务。参与者:成年人(18岁或以上)、《国际疾病和相关健康问题统计分类》第十版、酒精依赖诊断、基线评估时戒酒,收到无草甘膦的处方。干预措施:(1)标准支持,(2)药剂师通过临床联络中心提供的辅助药物管理标准支持(6个月内12次),(3)辅助药物管理加应急管理的标准支持,包括代金券(最高120英镑),以加强对药物管理的参与。同意的参与者以2:1:1的比例被随机分配到三组中的一组,使用分层随机排列块方法,使用远程系统。参与者和研究人员并非对治疗分配视而不见。主要结果指标:主要结果:随机分组后6个月,在前28天内自行报告的服药百分比。经济结果:EuroQol-5维度,一个五级版本,用于计算质量调整后的生命年,使用成人服务使用时间表估计成本。结果:在接触的1459名潜在参与者中,1019人(70%)接受了评估,739人(73人同意参与研究,372人(50%)接受了标准支持,182人(25%)获得药物管理标准支持,185人(25%的人)获得应急管理标准支持和药物管理。在6个月的随访中,518名(70%)参与者的数据可用,255名(68.5%)参与者分配给标准支持,122名(67.0%)参与者分配到标准支持和药物管理,141名(76.2%)参与者分配了标准支持和应急药物管理。在主要终点(6个月随访),接受标准支持和药物管理及应急管理的患者对非草甘膦的依从性百分比的平均差异(10.6%,95%置信区间19.6%-1.6%)高于单独接受标准支持的患者。当将标准支持和药物管理与单独的标准支持进行比较3.1%(95%置信区间12.8%-6.5%),或将标准支持与药物管理与标准支持和药品管理与应急管理进行比较7.9%(95%可信区间18.7%-2.8%)时,依从性天数百分比没有显着差异6个月时的分析发现,与单独使用标准支持相比,使用应急管理的标准支持和药物管理具有成本效益,以较低的每位参与者成本在质量调整后的生命年中实现了小幅增长。与单独的标准支持相比,辅助药物管理没有观察到成本效益。未报告与试验干预措施相关的严重不良事件。局限性:由于数据收集困难,试验的主要结果指标发生了重大变化,因此依赖于自我报告的依从性指标。12个月时低于预期的随访率可能降低了检测二次分析差异的统计能力,尽管一次分析没有受到影响。结论:通过应急管理加强药物管理有利于支持患者服用非草甘膦。未来的工作:鉴于我们在应急管理提高药物管理依从性方面的发现,应制定未来的试验,在有证据表明依从性较差的情况下,探索其与其他酒精干预措施的有效性和成本效益。试验注册:本试验注册为ISRCTN17083622https://doi.org/10.1186/ISRCTN17083622.Funding:该项目由国家卫生与保健研究所(NIHR)卫生技术评估计划资助,并将在《卫生技术评估》上全文发表;第27卷第22期。有关更多项目信息,请访问NIHR期刊图书馆网站。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Health technology assessment
Health technology assessment 医学-卫生保健
CiteScore
6.90
自引率
0.00%
发文量
94
审稿时长
>12 weeks
期刊介绍: Health Technology Assessment (HTA) publishes research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS.
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