Reducing Opioid Mortality in Illinois (ROMI): A case management/peer recovery coaching critical time intervention clinical trial protocol.

Individuals with a history of opioid use are disproportionately represented in Illinois jails and prisons and face high risks of overdose and relapse at community reentry. Case management and peer recovery coaching are established interventions that may be leveraged to improve linkage to substance use treatment and supportive services during these critical periods of transition. We present the protocol for the Reducing Opioid Mortality in Illinois (ROMI), a type I hybrid effectiveness-implementation randomized trial of a case management, peer recovery coaching and overdose education and naloxone distribution (CM/PRC + OEND) critical time intervention (CTI) compared to OEND alone. The CM/PRC + OEND is a novel, 12-month intervention that involves linkage to substance use treatment and support for continuity of care, skills building, and navigation and engagement of social services that will be implemented using a hub-and-spoke model of training and supervision across the study sites. At least 1000 individuals released from jails and prisons spanning urban and rural settings will be enrolled. The primary outcome is engagement in medication for opioid use disorder. Secondary outcomes include health insurance enrollment, mental health service engagement, and re-arrest/recidivism, parole violation, and/or reincarceration. Mixed methods will be used to evaluate process and implementation outcomes including fidelity to, barriers to, facilitators of, and cost of the intervention. Videoconferencing and other remote processes will be leveraged to modify the protocol for safety during the COVID-19 pandemic. Results of the study may improve outcomes for vulnerable persons at the margin of behavioral health and the criminal legal system.