Competitive Revision for CLARO: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

Study Overview
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Brief Summary
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The purpose of this study is to develop and then test an enhanced version of the parent study's collaborative care intervention for co-occurring disorders (CC-COD) to reduce the risk of suicide and overdose among individuals with opioid use disorder (OUD) in combination with PTSD/depression. The parent study is CLARO, Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (NCT04559893).

Detailed Description
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People with OUD co-occurring with depression or PTSD (COD) may not seek out treatment for their substance use or mental health issues, but they do visit their primary care provider. However, because providers generally lack specialized training in substance use and mental illness and are focused on the immediate reason for the visit, patients' substance use and mental disorders often go unrecognized and untreated. This missed opportunity can have lethal consequences. Individuals with COD are at higher risk of dying from suicide or overdose than individuals with mental illness or OUD alone. The parent study (NCT04559893) will provide a definitive answer as to whether collaborative care (CC) improves access, quality, and outcomes of care for individuals with COD. While a primary goal is to improve access to and retention in medication treatment for OUD (MOUD) (which is linked to decreased mortality and overdose risk), the interventions CC-COD supports do not proactively address suicide or overdose risk, an important limitation. In addition, CC-COD does not include families in the patient's care. The investigators address these limitations and tackle the public health crisis of increasing deaths from suicide and overdose with this study. Because family members can play an important role in a patient's decision to engage with treatment and in overdose and suicide prevention, the study team investigates family members' views and use this information to strengthen CC-COD. This revision will develop and then test the incremental effectiveness of three additional CC-COD components. Care coordinators will (1) educate family members about MOUD with the goal of increasing patient retention in treatment; (2) train family members and the patient to administer naloxone and on how to reduce overdose risk behaviors; and (3) implement Caring Contacts, a suicide prevention intervention that sends compassionate mailed or text messages to individuals to decrease social isolation and reduce suicide risk.

Official Title
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Competitive Revision for Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness

Conditions
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Opioid-use Disorder, Addiction, Depression, Post Traumatic Stress Disorder, Suicidal Ideation

Intervention / Treatment
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* Behavioral: Collaborative care Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 and older Receiving primary care at one of the participating clinical sites Has OUD and one or more specific co-occurring behavioral health disorders (depression and PTSD) Exclusion Criteria: Under 18 Does not speak English or Spanish Unable to consent Receiving both MOUD and psychotropic medication from a provider outside of the primary care health system at which the patient is enrolled. Not receiving primary care at one of the participating clinical sites

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: Two-arm randomized control trial (RCT) where participants are randomly assigned to intervention or control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative Care Plus<br>Intervention is administered to patients in this arm. Care to be delivered via collaborative care. The supplement intervention adds family involvement in care and Caring Contacts, a suicide prevention method. | Behavioral: Collaborative care Plus<br>* Collaborative care consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In this model, the CC team also includes a behavioral health psychotherapist (BHP) who consults on a regular basis but does not deliver direct care. In the Collaborative Care Plus condition, the care coordinator involves family in care, teaches family about naloxone use, and provides Caring Contacts, a suicide prevention method, to patients.<br>|
| No Intervention: Control<br>Patients in this arm will receive enhanced usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOUD continuity of care | Max number of continuous (i.e., no breaks of more than 7 days) days the patient receives MOUD in the 180 days after study enrollment; obtained from electronic health record (EHR) or from the Prescription Drug Monitoring Program for the State of New Mexico | Assessed over the first 180 days after study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid overdose risk behaviors | Measured as a sum of ratings on 9 risk behaviors from Opioid Overdose Risk Assessment (score 0-36). A high score indicates high risk. | Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry | 
| Suicide risk | Measured using Columbia Suicide Severity Rating Scales, classified into 6 levels (from no risk to suicide attempt) | Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collaborative care, Problem Solving Therapy, Written Exposure Therapy, Medication for addiction treatment, Addiction, Opioid use disorder, Suicide prevention, Overdose prevention