Funding Source
NIDA Clinical Trials Network (NIH HEAL Initiative), CTN-0079-A1
Project Period
6/1/2019 – 5/31/2022
Principal Investigator
Ryan McCormack, MD, MS (Greater NY Node; New York University) (Lead Investigator); Kathryn Hawk, MD, MHS (New England Consortium, Yale University) and John Rotrosen, MD (Greater NY Node, New York University) (Co-Lead Investigators); Gail D’Onofrio, MD (New England Consortium, Yale University); Lisa Marsch, PhD (Northeast Node, Geisel School of Medicine at Dartmouth) (Co-Investigators)
Other Project Staff
Phoebe Gauthier, MA, MPH (Northeast Node, Dartmouth College) (Lead Project Manager); Kelsey Veilleux, MD (Northeast Node, Dartmouth College) (Site Project Manager); Owen Murray, MA, MS, LMFT (Northeast Node, Dartmouth College) (Research Assistant).
Project Summary
CTN-0079-A1, an ancillary study to CTN-0079 Emergency Department Connection to Care with Buprenorphine for Opioid Use Disorder (ED-CONNECT), will evaluate the extent of diffusion and the sustainability of the Emergency Department (ED)-initiated buprenorphine (BUP) clinical programs (inclusive of opioid use disorder [OUD] screening, BUP treatment initiation, and referral for treatment) introduced at each of the three clinical sites in the parent CTN-0079 study in furtherance of our original overarching research question: In settings with high need, limited resources, and differing staffing structures for managing OUD, what is the feasibility and impact of introducing a clinical protocol for OUD screening and BUP treatment initiation in the ED with referral for treatment? CTN-0079-A1 is an implementation study that will use mixed methods and triangulate multiple sources of data to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness.
Public Health Relevance
It is imperative to maximize linkage to evidence-based care for OUD from less traditional settings such as the ED. It has been more than 3 years since D’Onofrio et al.’s landmark trial demonstrated the feasibility, safety, and efficacy of initiating treatment with BUP in the ED and, despite a highly visible opioid epidemic, few EDs have adopted this life-saving intervention. Currently, EDs are ill-equipped to respond. Developing and refining both an intervention inclusive of OUD screening, BUP treatment initiation, and facilitated referral that is practical for the ED as well as a pragmatic implementation strategy is critically needed. The RE-AIM framework allows the needed multi-level analysis of whether this efficacious treatment can be widely adopted and translated into meaningful outcomes in this real-world complex environment.