Abstract
BackgroundThis manuscript provides a research update to the ongoing pragmatic trial of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment), an emergency department-based peer recovery coaching intervention for linking patients with opioid use disorder to evidence-based treatment. The research team has encountered a number of challenges related to the “real-world” study setting since the trial began. Using an implementation science lens, we sought to identify and describe barriers impacting both the intervention and research protocols of the POINT study, which are often intertwined in pragmatic trials due to the focus on external validity.MethodQualitative data were collected from 3 peer recovery coaches, 2 peer recovery coach supervisors, and 3 members of the research team. Questions and deductive qualitative analysis were guided by the Consolidated Framework for Implementation Research (CFIR).ResultsNine unique barriers were noted, with 5 of these barriers impacting intervention and research protocol implementation simultaneously. These simultaneous barriers were timing of intervention delivery, ineffective communication with emergency department staff, lack of privacy in the emergency department, the fast-paced emergency department setting, and patient’s limited resources. Together, these barriers represent the intervention characteristics, inner setting, and outer setting domains of the CFIR.ConclusionResults highlight the utility of employing an implementation science framework to assess implementation issues in pragmatic trials and how this approach might be used as a quality assurance mechanism given the considerable overlap that exists between research and intervention protocols in real-world trial settings. Previously undocumented changes to the trial design that have been made as a result of the identified barriers are discussed.
Highlights
This paper provides a research update to a previously published manuscript of a pilot randomized pragmatic trial of Project Planned Outreach, Intervention, Naloxone, and Treatment (POINT), an emergency department (ED)-based intervention for engaging patients with opioid use disorder (OUD) and connecting them to evidence-based treatment [1]
The fact that the majority of barriers cut across aspects of both intervention and research implementation demonstrates the high degree to which aspects of the intervention of focus and research protocols can be intertwined within a pragmatic trial
The tension between real-world service delivery and pragmatic trial protocols has been discussed in prior literature [12, 19, 25, 26]; these discussions have largely focused on how attention to external validity can lead to questionable implementation of the intervention and type III error [4, 19, 27, 28]
Summary
The urgent need for interventions with potential to help address the opioid crisis is reflected in the 122% increase in opioid-related overdose deaths between 2010 and 2018 in the USA [2] This urgency has resulted in the development and implementation of a number of novel interventions that require rapid yet rigorous scientific assessment, which is not conducive to traditional explanatory trials [3]. We provide a discussion of the impact of these barriers on the study and their implications This manuscript provides a research update to the ongoing pragmatic trial of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment), an emergency department-based peer recovery coaching intervention for linking patients with opioid use disorder to evidence-based treatment. Using an implementation science lens, we sought to identify and describe barriers impacting both the intervention and research protocols of the POINT study, which are often intertwined in pragmatic trials due to the focus on external validity
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