Collaborating to Heal Addiction and Mental Health in Primary Care

Study Overview
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Brief Summary
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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.

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

Official Title
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Collaborating to Heal Addiction and Mental Health in Primary Care

Conditions
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Opioid-use Disorder, Mental Health Disorder

Intervention / Treatment
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* Other: Collaborative Care for Mental Health Disorders
* Other: Collaborative Care for Opioid Use Disorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster Randomized Trial. Clinics within healthcare systems are paired and randomized to intervention or control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collaborative Care for Mental Health Disorders<br>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. | Other: Collaborative Care for Mental Health Disorders<br>* 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.<br>|
| Experimental: Collaborative Care for Opioid Use Disorder<br>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. | Other: Collaborative Care for Mental Health Disorders<br>* 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.<br>Other: Collaborative Care for Opioid Use Disorder<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illicit Opioid Use | 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. | 6 months | 
| Change in Mental Health Functioning | Change in 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) | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Symptoms | Change in Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse) | 6 months | 
| Change in Anxiety Symptoms | Change in 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) | 6 months | 
| Change in PTSD Symptoms | Change in PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse) | 6 months | 
| Medications for Opioid Use Disorder (MOUD) Persistence | MOUD persistence will be measured from self report and specified as the ratio of the number of days the study participant reported taking the MOUD medication (numerator) to the number of days during the 6-month follow-up period for which it was prescribed (denominator). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Care, Collaborative Care