Design of CLARO plus (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses, Plus): A randomized trial of collaborative care to decrease overdose and suicide risk among patients with co-occurring disorders

Background: The United States is mired in two intertwined epidemics of death from suicide and overdose. Opioid use disorder (OUD) and mental illness contribute to both, and individuals with co-occurring disorders (CODs) are a complex population at high risk. Although universal prevention makes sense from a public health perspective, medical and behavioral health providers often lack the time to proactively address these issues with all patients. In this study, we build upon a parent study called Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO), a model of collaborative care in which care coordinators deliver preventative measures to high-risk patients and coordinate care with the patients' care team, with the goal of increasing MOUD retention and decreasing risk of suicide and overdose.Methods: CLARO+ adds intervention components on overdose prevention, recognition, and response training; lethal means safety counseling; and an effort to mail compassionate messages called Caring Contacts. Both CLARO and CLARO+ have been implemented at 17 clinics in New Mexico and California, and this study seeks to determine the difference in effectiveness between the two versions of the intervention. This paper describes the design protocol for CLARO+.Conclusion: CLARO+ is an innovative approach that aims to supplement existing collaborative care with additional suicide and overdose prevention strategies. ClinicalTrials.gov: NCT04559893