Collaboration Leading to Addiction Treatment and Recovery From Other Stresses (CLARO)

University of New Mexico, Boston Medical Center, First Choice Community Healthcare, Hidalgo Medical Services, National Institute of Mental Health (NIMH), Stanford University, University of Pittsburgh, Saint John's Cancer Institute, Olive View-UCLA Education & Research Institute

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.

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).

Collaborative care, Problem solving therapy, Written exposure therapy, Medication for addiction treatment, Addiction, Opioid-use disorder

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

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.

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

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

(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.

(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.

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

7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Substance Use Short Form for the previous 30 days; obtained from patient interview

3-item Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) for the previous 3 months; obtained from patient interview

Columbia Suicide Severity Rating Scales, analyzed as a continuous measure using a related Classification Algorithm; obtained from patient interview

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

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

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

4 psychotherapy visits in the first 8 weeks or an adequate (12-week) medication trial; obtained from EHR

4 psychotherapy visits in the first 8 weeks or an adequate (60-day) medication trial; obtained from EHR

Pain Intensity, Enjoyment of Life, General Activity (PEG) Pain Monitor for the past week; assessed as a covariate; obtained from patient interview

Indicated by the patient identifying a support person with whom they interact and who does not have problematic opioid use; obtained from patient interview; assessed as a covariate

Homelessness Screening Clinical Reminder Tool and one item from the Government Performance and Results Act (GPRA) clarifying where individuals who are homeless are currently living; assessed as a mediator; obtained from patient interview

Items from the NSDUH and the Addiction Severity Index; assessed as a covariate; obtained from patient interview

Asked about lifetime legal involvement; assessed at study entry and at 3 and 6 months after study entry

Rural-Urban Commuting Area code associated with the participant's five-digit zip code; assessed as a moderator

Agency for Healthcare Research and Quality (AHRQ) Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview

AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview

AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview

Modified Working Alliance Inventory-General Practitioner (WAI-GP); assessed as a mediator; obtained from patient interview

Veterans RAND 12-item Health Survey (VR-12); obtained from patient interview; analyzed as two component scores, mental and physical; assessed as a covariate

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

Per National Institute of Mental Health (NIMH) funding requirements, study data must be uploaded to the NIMH National Data Archive (NDA) every six months once data collection begins. A universal subject identifier called a Global Unique Identifier (GUID) will be generated for each participant. All raw data will be uploaded every six months to the NIMH NDA per their policies. Additionally, all analysis data sets used for manuscripts must be uploaded to the NIMH NDA, identified by GUID.

Every 6 months (January and July) following enrollment of the first patient. First submission expected July 2021. Submission will cease following sharing of final analysis data set for any specified outcomes publications.

Osilla KC, Dopp AR, Watkins KE, Ceballos V, Hurley B, Meredith LS, Leamon I, Jacobsohn V, Komaromy M. Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. Addict Sci Clin Pract. 2022 Apr 8;17(1):25. doi: 10.1186/s13722-022-00302-9.