NIDA Clinical Trials Network, CTN-0079
9/01/2017 - 5/31/2019
Ryan McCormack, MD, MS (NYU Langone Health)
Other Project Staff
John Rotrosen, MD (Co-Lead Investigator); Kathryn Hawk, MD, MHS (Co-Investigator); Lisa Marsch, PhD (Northeast Node, Node PI); Gail D’Onofrio MD (Co-Investigator); Phoebe Gauthier MA, MPH (National Project Manager); Patricia Novo, MPA, MPH (Co-National Project Manager); Sarah Farkas, MA (Lead Regulatory); Dee Blumberg PhD (CCC Project Manager); Dagmar Salazar, MS (CCC Protocol Specialist); Radhika Kondapaka MBBS, RAC (CCC Safety Monitor); Eve Jelstrom, MBA, CRNA (CCC Project Director); Robert Lindblad MD (CCC Medical Monitor); Tracy Dalrymple, MS (DSC Data Manager); Caroline Mulatya PhD (DSC Statistician); Lauren Yesko (DSC Project Director); David Liu, MD (CCTN Protocol Liaison); Kristen Huntley, PhD (CCTN Protocol Liasion); Andrea Meier, MS, LADC, LCMHC (Northeast Node); Bethany McLeman, BA (Northeast Node)
Our central research question is: In settings with high need, limited resources, and differing staffing structures for managing opioid use disorder (OUD), what is the feasibility and impact of introducing a clinical protocol for OUD screening and buprenorphine (BUP, either as sublingual [SL-BUP] or extended-release [XR-BUP]) treatment initiation in the Emergency Department (ED) with referral for treatment?
1. To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.
2. Over the course of the study and as XR-BUP is added to hospital formularies, to estimate the percentage and confidence intervals of patients assessed, treated, and engaged in treatment at Day 30.
This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact. We will develop, introduce and update site-specific ED clinical protocols and implementation plans for OUD screening, ED-initiated BUP, and referral for treatment. We will employ a participatory action research approach and use mixed methods incorporating data derived from:
1. Medical record and administrative data abstraction,
2. Research assessments involving patients who are eligible for and willing to receive ED-initiated BUP (including both those who do, and do not, receive BUP); these assessments will document the index ED visit and the 30th day after the index ED visit,
3. Qualitative interviews, focus groups, and quantitative assessments involving providers and staff, patients, and other stakeholders.
Public Health Relevance
The opioid epidemic has a large and growing impact on public health, and continues to decimate communities ill equipped to provide substantive, timely intervention. By assembling subject matter experts and involving local stakeholders, we will translate successful elements of efficacious interventions to EDs operating in different contexts. These partnerships provide an opportunity for prompt, meaningful and sustainable dissemination with enhanced support for the intervention while it is being developed and tested in situ. This study is designed to provide the necessary, time-sensitive understanding of how to identify OUD and initiate treatment with BUP in the EDs where this intervention is most needed – which, if successfully done, should save lives, improve outcomes, and reduce costs to society.