University of Illinois at Chicago, College of Medicine, Department of Medicine, Center for Dissemination and Implementation Science, 1603 W. Taylor St., Chicago, IL 60612, United States of America.
Indiana University School of Medicine, Department of Emergency Medicine, 720 Eskenazi Ave., Indianapolis, IN 46202, United States of America.
J Subst Abuse Treat. 2020 Jan;108:88-94. doi: 10.1016/j.jsat.2019.06.002. Epub 2019 Jun 6.
Solving the opioid crisis requires immediate, innovative, and sustainable solutions. A number of promising strategies are being carried out by U.S. states and territories as part of their Opioid State Targeted Response (STR) plans funded through the 21st Century Cures Act, and they provide an opportunity for researchers to assess effectiveness of these interventions using pragmatic approaches. This paper describes a pilot study of Project Planned Outreach, Intervention, Naloxone, and Treatment (POINT), the intervention that served as the basis for Indiana's STR-funded, emergency department (ED)-based peer specialist expansion that was conducted in preparation for a larger, multisite pragmatic trial. Through the pilot, we identified, documented, and corrected for challenges encountered while implementing planned study protocols. Per the project's funding mechanism, the ability to move to the larger trial was determined by the achievement of 3 milestones: (1) successful replication of the intervention; (2) demonstrated ability to obtain the necessary sample size; and (3) observe a higher level of engagement in medication for addiction treatment in the POINT group compared to standard care. Overall implementation of the study protocols was successful, with only minor refinements to proposed procedures being required in light of challenges with (1) data access, (2) recruitment, and (3) identification of the expansion hospitals. All three milestones were reached. Challenges in implementing protocols and reaching milestones resulted in refinements that improved the study design overall. The subsequent trial will add to the limited but growing evidence on ED-based peer supports. Capitalizing on STR efforts to study an already scaling and promising intervention is likely to lead to faster and more sustainable results with greater generalizability than traditional, efficacy-focused clinical research.
解决阿片类药物危机需要立即采取创新和可持续的解决方案。美国各州和地区正在根据《21 世纪治愈法案》资助的阿片类药物州目标应对计划（STR）实施多项有希望的策略，这为研究人员提供了机会，通过实用方法评估这些干预措施的有效性。本文描述了一项计划外展、干预、纳洛酮和治疗（POINT）项目的试点研究，该干预措施是印第安纳州 STR 资助的、基于急诊室的同伴专家扩展的基础，该扩展是为更大规模、多地点实用试验做准备而进行的。通过试点，我们确定、记录并纠正了在实施计划研究方案时遇到的挑战。根据项目的资助机制，能否进入更大规模的试验取决于三个里程碑的实现：（1）成功复制干预措施；（2）证明有能力获得必要的样本量；（3）观察到 POINT 组中接受药物治疗成瘾的参与度高于标准护理。研究方案的总体实施是成功的，仅对提议的程序进行了微小的改进，以应对以下挑战：（1）数据访问、（2）招募和（3）确定扩展医院。所有三个里程碑都已达到。实施协议和达到里程碑所面临的挑战导致了改进，从而整体上改善了研究设计。随后的试验将增加基于急诊室的同伴支持的有限但不断增长的证据。利用 STR 努力研究已经扩展且有前途的干预措施，可能会比传统的、以疗效为重点的临床研究更快、更可持续地产生更具普遍性的结果。
