Collaborating to Heal Addiction and Mental Health in Primary Care

Completed · Not applicable

Conditions studied: Opioid-use Disorder, Mental Health Disorder

In brief

The gold-standard intervention for Opioid Use Disorder (OUD) is Medication for Opioid Use Disorder (MOUD). Because more patients with OUD need access to MOUD in primary care, the investigators are testing whether the Collaborative Care model (CoCM) is effective at treating both mental health disorders (MHD) and OUD concurrently in primary care settings. The intervention is CoCM for MHD and OUD. The active control is CoCM for MHD, but not treating OUD. The primary objective is to compare patient-reported outcomes in the intervention and control groups, and will be tested with in an Effectiveness trial. The secondary objective is to compare the detection of OUD pre- versus post-OUD screening implementation, and will be tested using a Pre-Post trial design. The exploratory objective is to compare intervention clinics randomized to a low-intensity sustainability implementation strategy or a high-intensity sustainability strategy, and will be tested in an Implementation trial.

Key facts

Study ID

NCT04600414

Run by

University of Washington

People needed

254

Starts

2020-11-16

Expected to finish

2024-08-31

Last updated by the study team

2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Screen positive on the NIDA-ASSIST OUD items or referred to the trial by one of the clinic's providers AND
• Meet clinical criteria for ≥2 symptoms of OUD on the DSM-5 checklist (administered by a clinician) AND
• Screen positive for depression on the PHQ-9 (≥ 5) OR generalized anxiety on the GAD-7 (≥ 5) OR PTSD on the PC-PTSD-5 (≥ 1) within past 6 months.

You may not qualify if…

• Patient is being prescribed psychotropic medication (including MOUD) by a Mental Health Care Specialist (typically practicing in a specialty addiction treatment setting).
• Patient is receiving or prefers to seek OUD treatment in specialty care setting including opioid treatment programs
• Patient does not speak English or Spanish
• Patient is younger than 18 years of age
• Patient has a diagnosis of dementia
• Patient lacks the capacity to provide informed consent
• Patient doesn't plan on getting care at the clinic for the next 6 months.

Where it is running

• Unity Health Care Minnesota Avenue Health Center — Washington D.C., District of Columbia, United States
• Unity Health Care Anacostia Health Center — Washington D.C., District of Columbia, United States
• Emory University Hospital Midtown-Radiology — Atlanta, Georgia, United States
• Emory Clinic at Saint Joseph's - Primary Care — Atlanta, Georgia, United States
• Emory at Dunwoody - Family Medicine — Dunwoody, Georgia, United States
• Emory at Rockbridge - Primary Care & Nephrology — Stone Mountain, Georgia, United States
• Kootenai Clinic Family Medicine Ironwood — Coeur d'Alene, Idaho, United States
• Kootenai Clinic Family Medicine Residency — Coeur d'Alene, Idaho, United States
• Kootenai Clinic Internal Medicine Coeur d'Alene — Coeur d'Alene, Idaho, United States
• Kootenai Clinic Family Medicine Post Falls — Post Falls, Idaho, United States
• Minooka Healthcare Center - Ridge Road Campus — Channahon, Illinois, United States
• Oak Street Health Madison St. — Chicago, Illinois, United States
• Oak Street Health Hermosa — Chicago, Illinois, United States
• Gardner Healthcare Center of Morris Hospital — Gardner, Illinois, United States
• Minooka Healthcare Center of Morris Hospital - Mondamin St. — Minooka, Illinois, United States
• Morris Healthcare Center of Morris Hospital - Dresden Drive — Morris, Illinois, United States
• Oak Street Health Chicago Ave Primary Care Clinic — Oak Park, Illinois, United States
• Oak Street Health Gary Primary Care Clinic — Gary, Indiana, United States
• Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates — Beverly, Massachusetts, United States
• Beth Israel Deaconess HealthCare-Chelsea — Chelsea, Massachusetts, United States
• Berkshire Hillcrest Family Health Center — Pittsfield, Massachusetts, United States
• Berkshire Williamstown Medical — Williamstown, Massachusetts, United States
• OneWorld Community Health Centers Livestock Exchange — Omaha, Nebraska, United States
• OneWorld Community Health Centers Northwest — Omaha, Nebraska, United States
• Oak Street Health Pleasant Grove Primary Care Clinic — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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