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适应芬太尼流行:急诊科纵向综合护理(ED-LINC)随机临床试验的快速定性观察及衍生的临床和研究意义

Adapting to the Fentanyl Epidemic: Rapid Qualitative Observations and Derived Clinical and Research Implications from the Emergency Department Longitudinal Integrated Care (ED-LINC) Randomized Clinical Trial.

作者信息

Lovett Kayla, Zatzick Douglas, Palinkas Lawrence A, Engstrom Allison, Nye Emily, Field Craig, McGovern Mark, Parrish Canada, Banta-Green Caleb J, Whiteside Lauren K

出版信息

Psychiatry. 2025 Mar 18:1-18. doi: 10.1080/00332747.2025.2472429.

Abstract

OBJECTIVE

The Emergency Department Longitudinal Integrated Care (ED-LINC) randomized clinical trial (NCT05327166) tests a Collaborative Care-informed intervention for emergency department (ED) patients with opioid use disorder. The ED-LINC intervention was developed before the current fentanyl epidemic; less than 10% of ED-LINC pilot intervention patients reported fentanyl use. To understand fentanyl's impact on the ED-LINC protocol, we utilized a systematic rapid qualitative approach to document clinical observations related to ED-LINC patients' fentanyl use and subsequent protocol modifications.

METHOD

This study utilized Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) methods to document fentanyl-related clinical observations. As participant observers, the team worked with a mixed methods consultant to analyze observations, informing adaptation to study protocol and intervention.

RESULTS

From 4/12/2022 to 2/10/2023, 86 patients enrolled in the ED-LINC trial. Forty received the ED-LINC intervention and are included in this study. Investigators identified the following themes informing adaptation to the ED-LINC intervention: 1) fentanyl-related suicide risk, 2) fentanyl-catalyzed approach to Medications for Opioid Use Disorder (MOUD), 3) fentanyl-related adaptations to measurement-based care embedded in the Collaborative Care approach, 4) fentanyl-associated survival needs, and 5) engagement challenges with fentanyl. Adaptations included incorporating overdose prevention into suicide risk assessment, nontraditional MOUD induction, and shifting to a component-driven model.

CONCLUSIONS

The landscape of clinical practice can change quickly and may require both researchers and healthcare providers to quickly pivot. Rapid assessment procedures integrated into clinical trial investigation allow for modifications and adaptations to study protocols to ensure salient and generalizable results given the rapidly evolving opioid epidemic.

摘要

目的

急诊科纵向综合护理(ED-LINC)随机临床试验(NCT05327166)测试了一种针对患有阿片类药物使用障碍的急诊科(ED)患者的基于协作护理的干预措施。ED-LINC干预措施是在当前芬太尼流行之前制定的;不到10%的ED-LINC试点干预患者报告使用过芬太尼。为了解芬太尼对ED-LINC方案的影响,我们采用了系统的快速定性方法来记录与ED-LINC患者芬太尼使用及后续方案修改相关的临床观察结果。

方法

本研究采用基于快速评估程序的临床人种学(RAPICE)方法来记录与芬太尼相关的临床观察结果。作为参与观察者,该团队与一位混合方法顾问合作分析观察结果,为研究方案和干预措施的调整提供依据。

结果

从2022年4月12日至2023年2月10日,86名患者参加了ED-LINC试验。40名接受了ED-LINC干预并纳入本研究。研究人员确定了以下指导ED-LINC干预措施调整的主题:1)与芬太尼相关的自杀风险,2)芬太尼催化的阿片类药物使用障碍药物治疗(MOUD)方法,3)芬太尼相关的对协作护理方法中基于测量的护理的调整,4)与芬太尼相关的生存需求,以及5)与芬太尼相关的参与挑战。调整措施包括将过量用药预防纳入自杀风险评估、采用非传统的MOUD诱导方法,并转向基于组件的模式。

结论

临床实践情况可能迅速变化,可能需要研究人员和医疗保健提供者迅速做出调整。将快速评估程序纳入临床试验调查可对研究方案进行修改和调整,以确保在阿片类药物流行迅速演变的情况下获得显著且可推广的结果。

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