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Hybrid Effectiveness-Implementation Clinical Trials to Optimize the Collaborative Care Model for Patients with Opioid Use Disorders and Mental Health Conditions


Michael C. Freed, Ph.D., EMT-B
Division of Services and Intervention Research


In April 2018, the NIH launched the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. In response to this initiative, the National Institute of Mental Health (NIMH), in partnership with other NIH Institutes, proposes research to adapt collaborative care – a specific service delivery model for treating mental/behavioral health conditions in primary care settings – to meet the needs of individuals with opioid use disorders (OUDs) and co-occurring mental health conditions. Hybrid effectiveness-implementation clinical trials are envisioned to develop, optimize, and test collaborative models that offer Medication-Assisted Treatment (MAT) for OUD alongside indicated treatment for mental health conditions frequently encountered in primary care such as mood and anxiety disorders.


Substantial evidence documents the effectiveness of certain medications, particularly buprenorphine and methadone, for treating opioid use disorders, especially when such medications are combined with behavioral health counseling and delivered via coordinated MAT. MAT can significantly increase rates of recovery and reduce risk of fatal and non-fatal overdose. However, only around one in five people with OUD receive any specific treatment, and only a minority of those receive MAT. Even among individuals who do receive indicated OUD treatments, effectiveness in current usual practice is limited. Geographic availability of clinicians who provide MAT and other indicated OUD treatments is highly variable and is especially limited in rural and other areas where OUD morbidity and mortality rates have risen most steeply; the Substance Abuse and Mental Health Services Administration reports that approximately half of U.S. counties lack even one practicing mental/behavioral health specialty clinician. Together, these factors identify an urgent need for better models of care for individuals with OUD, to improve access, quality, and outcomes. Over 80 randomized controlled trials demonstrate the effectiveness of collaborative care for improving outcomes among patients presenting in primary care with various common mental/behavioral health conditions. Collaborative care adds several key elements to standard practice, including care coordination; case consultation to the primary care team from a behavioral health specialist (who often participate remotely); patient registries to identify, track, and monitor eligible patients; measurement-based care focusing on treatment-to-target; and shared patient-provider decision making. Compared to usual practice, collaborative care improves many outcomes and is relatively cost-effective and sometimes cost-saving. Collaborative care holds promise as an effective, scalable, sustainable, and readily implementable service delivery model for people with complex needs.

Evidence supporting collaborative care is strongest for common mental disorders but is less robust for OUD and other substance use disorders; similarly, while collaborative care trials focusing on common mental disorders have typically included patients with co-occurring substance use disorders, effectiveness for those with and without such co-occurring conditions has not been examined.