Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

Study Overview
=================
Brief Summary
-----------------
Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO) is a five-year project that tests whether delivering care using a collaborative model helps patients with both opioid use disorders and mental health disorders.

Detailed Description
-----------------
Untreated mental illness and substance use disorders are prevalent and can have devastating consequences for the individual, their families and the community. Co-occurring opioid use disorders (OUD) with either depressive disorders and/or post-traumatic stress disorder (PTSD) are of particular concern, because depression and PTSD are prevalent in people with OUD, co-occurring mental illness is linked to an increased risk for opioid misuse and overdose, and because of the high prevalence of the chronic use of prescription opioids in individuals with mental illness, a risk factor for heroin use and the development of an OUD. Primary care is an important and underutilized setting in which to provide treatment for all three disorders, because OUD, depression and PTSD are frequently co-morbid with medical conditions. However, despite the effectiveness of treatments for all three disorders, many individuals never receive treatment; and, when treatment is provided, quality is low. With the rising number of opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. Collaborative care (CC) has never been tested with co-occurring disorders (COD), despite research by our team suggesting it may be effective. CC 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 our CC model for COD (CC-COD), the CC team also includes a behavioral health psychotherapist (BHP); the evidence-based treatments supported include medications for OUD (MOUD), pharmacotherapy for depression and PTSD, motivational interviewing (MI), problem solving therapy (PST) and Written Exposure Therapy (WET). The current study consists of a multi-site, randomized pragmatic trial in rural and urban primary care clinics located in Health Professional Shortage Areas (HPSA) of New Mexico and California to adapt, harmonize and then test whether CC-COD improves access, quality and outcomes for primary care patients with co-morbid OUD and depression and/or PTSD. The study will randomize 900 patients with co-occurring OUD and depression disorder and/or PTSD to receive either CC-COD or enhanced usual care (EUC).

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

Conditions
-----------------
Opioid-use Disorder, Addiction, Depression, Post-traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Collaborative Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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<br>Intervention is administered to patients in this arm. Care to be delivered via collaborative care. | Behavioral: Collaborative Care<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 our model, the CC team also includes a behavioral health psychotherapist (BHP) who consults on a regular basis but does not deliver direct care.<br>|
| No Intervention: Control<br>Patients in this arm will receive enhanced usual care. | |

What is the study measuring?
-----------------
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 | 
| MOUD access | Patients with a new episode of OUD care (i.e., no care for at least 60 days prior) receiving an MOUD prescription within 30 days; obtained from EHR | Assessed over the first 30 days after study entry | 
| Major Depressive Disorder (MDD) symptoms | (Patient Health Questionnaire) PHQ-9 (change in raw score from baseline); obtained from patient interview. PHQ-9 is scored from 0-36, with higher scores indicating worse symptoms. | Assessed over the previous 2 weeks at study entry and at 3 and 6 months after study entry | 
| Post-traumatic Stress Disorder (PTSD) symptoms | (PTSD Checklist) PCL-5 (change in raw score from baseline); obtained from patient interview. PCL-5 is scored from 0-80, with higher scores indicating worse symptoms. | Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use frequency | Days of use in the past 30 days for illegal substance use (not alcohol or cannabis) and five specific five drug categories (prescription opioids, heroin, cocaine/crack, methamphetamine/ other stimulants, and tranquilizers/sedatives), measured using SAMHSA National Survey on Drug Use and Health (NSDUH) items; obtained from patient interview | Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry | 
| Opioid use severity | 7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Substance Use Short Form for the previous 30 days; obtained from patient interview | Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry | 
| Alcohol use frequency | 3-item Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) for the previous 3 months; obtained from patient interview | Assessed over the previous 3 months at study entry and at 3 and 6 months after study entry | 
| Opioid overdose events | Naloxone Overdose Baseline Questionnaire for past 3 months; obtained from patient interview | Assessed over the previous 3 months at study entry and at 3 and 6 months after study entry | 
| Suicidality | Columbia Suicide Severity Rating Scales, analyzed as a continuous measure using a related Classification Algorithm; obtained from patient interview | Assessed over the previous 30 days at 3 and 6 months after study entry | 
| All-cause mortality | Mortality as reported in National Death Index | Assessed over the first 180 days after study entry | 
| MOUD initiation | Patients with a new episode of OUD care (i.e., no care for at least 60 days prior) receiving an MOUD prescription within 14 days of diagnosis; obtained from EHR | Assessed over the first 14 days after study entry | 
| MOUD engagement | Patients with a new episode of OUD care (i.e., no care for at least 60 days prior) receiving two or more MOUD prescriptions within 34 days of diagnosis; obtained from EHR | Assessed over the first 34 days after study entry | 
| Access to MDD and/or PTSD treatment | Receipt of medication and/or behavioral treatment associated with diagnosis for new episodes of MDD or PTSD care (a new episode is defined as no visits associated with that diagnosis in the previous six months); obtained from EHR | Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry | 
| Quality of care for MDD | 4 psychotherapy visits in the first 8 weeks or an adequate (12-week) medication trial; obtained from EHR | Assessed over the first 12 weeks after study entry | 
| Quality of care for PTSD | 4 psychotherapy visits in the first 8 weeks or an adequate (60-day) medication trial; obtained from EHR | Assessed over the first 60 days after study entry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Collaborative care, Problem solving therapy, Written exposure therapy, Medication for addiction treatment, Addiction, Opioid-use disorder