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.

Collaborating to Heal Addiction and Mental Health in Primary Care

Opioid-use Disorder

Mental Health Disorder

This multi-site study involves a sequence of trials (Pre-Post -> Effectiveness -> Implementation 3) to examine our primary, secondary and exploratory objectives.

1. Pre-Post trial (secondary objective) - Screening for Opioid User Disorder (OUD) will be integrated into Mental Health Disorder (MHD) screening and electronic health record (EHR) data will be used to determine if screening improves the detection of new cases of OUD during the first six months of the trial compared to the six months prior.
2. Cluster randomized Effectiveness trial (primary objective) - The primary objective of the trial is to test the effectiveness of delivering (Medication for OUD) MOUD in the context of Collaborative Care Management (CoCM) for MHD, hereafter termed the "intervention" compared to CoCM for MHD only hereafter termed the "control". All 24 sites have previously partnered with the AIMS Center to implement CoCM for MHD. After monitoring CoCM for MHD fidelity during a three month "run in" phase, the investigators will categorize clinics into one of two cohorts and then randomize them.

   * Cohort 1 (n=600) - Randomize clinics with high CoCM for MHD fidelity to sequentially adding MOUD for OUD (intervention group) or maintenance CoCM for MHD only (control group).
   * Cohort 2 (n=600) - Randomize clinics with low CoCM for MHD fidelity to simultaneous implementation of CoCM for MHD and OUD (intervention group ) or CoCM for MHD only (control group).
3. Cluster randomized Implementation trial (exploratory objective) - At the end of the Effectiveness trial, the intervention clinics will be randomized to receive a low-intensity or high-intensity implementation strategy to promote sustainability

Collaborative Care for Mental Health Symptoms

Collaborative Care for Opioid Use Disorder and Mental Health Symptoms

Illicit opioid use will be measured from self-report using Opioid use will be measured using item 7E from the Brief Addiction Monitor (BAM) with the following preamble: "The next question asks about your use of street opioids and use of prescription opioids that were not prescribed to you by a healthcare provider. In the past 30 days, how many days did you use opiates such as Heroin, Morphine, Dilaudid, Demerol, Oxycontin, oxy, codeine (e.g., Tylenol 2,3,4), Percocet, Vicodin, Fentanyl, etc.? Do not count times you used buprenorphine, suboxone, or methadone as directed by a healthcare provider."

Mental health functioning will be measured from self-report using the Mental Health Component Summary Score from the SF12V (range 0-100, higher scores are better)

Professor, School of Medicine

Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse)

Anxiety symptoms will be measured from self report using the PROMIS Measure - Emotional Distress, Anxiety, Short Form 7a (range 0-100, higher scores are worse)

PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse)

MOUD persistence will be measured from self report and specified as the proportion of days the study participant reported taking the MOUD medication during the 90 prior to the 6-month follow-up.

Collaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for mental health disorders.

Collaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for opioid use disorder.

Unity Health Care Minnesota Avenue Health Center

Unity Health Care Anacostia Health Center

Emory University Hospital Midtown-Radiology

Emory Clinic at Saint Joseph's - Primary Care

Emory at Dunwoody - Family Medicine

Emory at Rockbridge - Primary Care & Nephrology

Kootenai Clinic Family Medicine Ironwood

Kootenai Clinic Family Medicine Residency

Kootenai Clinic Internal Medicine Coeur d'Alene

Kootenai Clinic Family Medicine Post Falls

Minooka Healthcare Center - Ridge Road Campus

Oak Street Health Madison St.

Oak Street Health Hermosa

Gardner Healthcare Center of Morris Hospital

Minooka Healthcare Center of Morris Hospital - Mondamin St.

Morris Healthcare Center of Morris Hospital - Dresden Drive

Oak Street Health Chicago Ave Primary Care Clinic

Oak Street Health Gary Primary Care Clinic

Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates

Beth Israel Deaconess HealthCare-Chelsea

Berkshire Hillcrest Family Health Center

Berkshire Williamstown Medical

OneWorld Community Health Centers Livestock Exchange

OneWorld Community Health Centers Northwest

Oak Street Health Pleasant Grove Primary Care Clinic

Oak Street Health Meadowbrook Primary Care Clinic

Oak Street Health North Side Primary Care

Northshore Medical Group Stevenson

PeaceHealth Family Medicine of Southwest Washington

Peace Health Fisher's Landing

Northshore Medical Group White Salmon

UW Health Yahara Clinic

UW Health Deforest-Windsor Clinic

Collaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for mental health conditions.

Collaborative Care (CoCM) is based on six key principles: 1) evidence-based, 2) measurement-based, 3) team-based, 4) population-based, 5) patient-centered, and 6) accountable. CoCM supports the delivery of evidence-based pharmacological and psychosocial treatments. CoCM is measurement-based with screening and monitoring of patient-reported outcomes over time to assess treatment response and facilitate treatment adjustments. CoCM is team-based led by a primary care provider with support from a care manager in consultation with a psychiatrist who provides treatment recommendations for patients who are not responding. CoCM is population-based whereby a registry is used to monitor treatment engagement and facilitate the identification of patients falling through the cracks. CoCM is patient-centered with proactive outreach to engage and activate patients. Collaborative care is accountable with continuous quality improvement to meet clinic performance benchmarks.

Collaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for mental health conditions and opioid use disorder.

Collaborative Care for Opioid Use Disorder: Pharmacologic treatment of OUD will rely mainly on transmucosal buprenorphine/naloxone prescribed by primary care providers with DATA 2000 waivers. Measurement-based care and "treat to target" are fundamental principles of CoCM and will be incorporated into the intervention. Care managers will ask four yes/no questions about: 1) opioid withdrawal symptoms, 2) illicit opioid craving, 3) illicit opioid use, 4) medication side effects. If necessary, consulting psychiatrists will then recommend a change to the treatment plan to the primary care provider. In the case of buprenorphine/naloxone, options for changing the treatment plan include: 1) increasing the dosage (max dose 32mg), 2) augmenting with clonidine, 3) switching to injectable buprenorphine, and/or 4) intensifying psychosocial interventions. If the patient is experiencing medication side effects, but not opioid withdrawal symptoms or illicit opioid craving, consideration will be given to lowering the medication dosage.

Total

Age, Continuous

Woman

Non-binary or gender fluid

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Opioid Use Other Than As Prescribed

Mental Health Functioning

Not all enrolled patients completed the baseline survey.

John Fortney, Professor

Participants completing the 6-month follow-up survey.

Depression Symptoms

Anxiety Symptoms

PTSD Symptoms

Medications for Opioid Use Disorder (MOUD) Persistence

Perceived access to care will be measured from self report using the Assessment of Perceived Access to Care (APAC) instrument (range 1-5, higher scores are better)

Perceived Access to Addiction Care for Opioid Use Disorder

Risk factors will include self-reported intent on self-harm, self-reported overdose, self-reported discontinuation of medications for opioid use disorder and the following adverse events reports: overdose, suicide attempt, hospitalization and ER admission.

Collaborating to Heal Addiction and Mental Health in Primary Care

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?