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.

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.