Hartzler Bryan, Peavy K Michelle, Jackson T Ron, Carney Molly
Alcohol and Drug Abuse Institute, University of Washington, Box 354805, 1107 NE 45th Street, Suite 120, Seattle, WA, 98105-4631, USA.
Addict Sci Clin Pract. 2016 Jan 22;11(1):2. doi: 10.1186/s13722-016-0049-6.
Pragmatic trials of empirically-supported behavior therapies may inform clinical and policy decisions concerning therapy sustainment. This retrospective trial design paper describes and discusses pragmatic features of a hybrid type III implementation/effectiveness trial of a contingency management (CM) intervention at an opioid treatment program. Prior reporting (Hartzler et al., J Subst Abuse Treat 46:429-438, 2014; Hartzler, Subst Abuse Treat Prev Policy 10:30, 2015) notes success in recruiting program staff for voluntary participation, durable impacts of CM training on staff-level outcomes, provisional setting implementation of the intervention, documentation of clinical effectiveness, and post-trial sustainment of CM.
METHODS/DESIGN: Six pragmatic design features, and both scientific and practical bases for their inclusion in the trial, are presented: (1) a collaborative intervention design process, (2) voluntary recruitment of program staff for therapy training and implementation, (3) serial training outcome assessments, with quasi-experimental staff randomization to either single or multiple baseline assessment conditions, (4) designation of a 90-day period immediately after training in which the setting implemented the intervention on a provisional basis, (5) inclusive patient eligibility for receipt of the CM intervention, and (6) designation of two staff as local implementation leaders to oversee clinical/administrative issues in provisional implementation.
Each pragmatic trial design feature is argued to have contributed to sustainment of CM. Contributions implicate the building of setting proprietorship for the CM intervention, culling of internal staff expertise in its delivery, iterative use of assessment methods that limited setting burden, documentation of setting-specific clinical effectiveness, expanded penetration of CM among staff during provisional implementation, and promotion of setting self-reliance in the oversight of sustainable implementation procedures. It is hoped this discussion offers ideas for how to impact local clinical and policy decisions via effective behavior therapy dissemination.
经验支持的行为疗法的实用性试验可为有关治疗维持的临床和政策决策提供信息。本回顾性试验设计论文描述并讨论了在阿片类药物治疗项目中进行的应急管理（CM）干预的混合型III期实施/有效性试验的实用特征。先前的报告（Hartzler等人，《药物滥用治疗杂志》46:429 - 438，2014年；Hartzler，《药物滥用治疗、预防与政策》10:30，2015年）指出，在招募项目工作人员自愿参与方面取得了成功，CM培训对工作人员层面的结果产生了持久影响，干预措施在临时环境中得以实施，记录了临床有效性，以及试验后CM的持续应用。
方法/设计：介绍了六个实用设计特征及其纳入试验的科学和实践依据：（1）协作性干预设计过程；（2）自愿招募项目工作人员进行治疗培训和实施；（3）系列培训结果评估，工作人员通过准实验随机分配到单基线或多基线评估条件；（4）在培训后立即指定一个90天的时间段，在此期间该环境临时实施干预措施；（5）CM干预措施的患者纳入标准具有包容性；（6）指定两名工作人员作为当地实施负责人，以监督临时实施中的临床/管理问题。
每个实用试验设计特征都被认为对CM的持续应用起到了作用。这些作用包括为CM干预建立环境所有权，挑选内部工作人员在实施过程中的专业知识，反复使用限制环境负担的评估方法，记录特定环境下的临床有效性，在临时实施期间扩大CM在工作人员中的渗透，以及在监督可持续实施程序方面促进环境的自力更生。希望这一讨论能为如何通过有效传播行为疗法影响当地临床和政策决策提供思路。
