Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness - Recruitment Extension

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PROJECT SUMMARY/ABSTRACT Summary: Despite challenges from the Covid-19 pandemic, our HEAL-funded clinical trial, CLARO (Collaboration Leading to Addiction Treatment and Recovery from Other Stresses) has been successfully recruiting patients. We are seeking additional funding to cover an additional 8 months of recruitment costs. With this additional funding it is highly likely we will be able to meet our recruitment targets and complete the study within the original study timeline. Completion of human subject enrollment is critical for project success; without completion of enrollment the entire investment in the trial for both the parent study and the competitive revision is at-risk. Overview: In 2019, the RAND Corporation, in collaboration with the University of New Mexico, Boston Medical Center and three healthcare systems, was funded under RFA-MH-19-525 to adapt and then test the Collaborative Care model for individuals with opioid use disorders and co-occurring depression and/or PTSD. Collaborative Care is a service delivery model for treating mental and behavioral health conditions in primary care settings but has not been tested for co-occurring mental and substance use disorders. The trial is intended to definitively answer whether the model, when implemented across diverse practice settings, results in improved mental health and substance use outcomes. In 2020, RAND received additional funding through a competitive revision (CR). The CR uses the same procedures, methods and measures as the parent study, and tests whether adding components specifically directed at reducing suicide and overdose risk provides additional benefit compared to the original CLARO model. The CR supports recruiting of 300 patients in addition to the 900 patients to be enrolled in the parent study. Our ability to recruit patients was compromised during the Covid-19 pandemic. The study had planned to recruit patients through a universal screening approach where research assistants stationed in primary care clinic waiting rooms would screen patients for study eligibility. Because of the pandemic, our clinic partners began to provide most care virtually, which limited our ability to screen and recruit patients in-person. Although we pivoted and implemented telephone screening for patients identified in the electronic health record, enrollment was significantly compromised. Our target sample size is N=900 for the parent study, and N=300 for the CR; the two studies are linked because the design of the CR takes advantage of data from patients enrolled into the parent study to estimate the incremental effectiveness of the enhanced version of CLARO compared to the parent study. Thus, investment in both studies is at-risk should we be unable to complete patient enrollment for both studies. To date we have enrolled 521 individuals out of our proposed 1200. In the fall of 2021, we were allowed to resume universal screening again, although several of our clinics have continued until recently to provide most of their care virtually.