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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Addiction; Opioid-use Disorder; Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Collaborative Care

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).

• Study Type: Interventional
• Enrollment (Actual): 796
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90003
      • Hubert Humphrey Comprehensive Health Center
    • Santa Monica, California, United States, 90404
      • Providence Saint John's Health Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • First Choice Community Healthcare - South Broadway Medical Center
    • Albuquerque, New Mexico, United States, 87105
      • First Choice Community Healthcare - South Valley Medical/Dental Center
    • Albuquerque, New Mexico, United States, 87107
      • First Choice - Alameda Medical Center
    • Albuquerque, New Mexico, United States, 87107
      • First Choice Community Healthcare - North Valley Medical Center
    • Albuquerque, New Mexico, United States, 87107
      • University of New Mexico Family Health Clinic, North Valley
    • Albuquerque, New Mexico, United States, 87108
      • University of New Mexico Family Health Clinic, Southeast Heights
    • Albuquerque, New Mexico, United States, 87121
      • First Choice Community Healthcare - Alamosa Medical Center
    • Albuquerque, New Mexico, United States, 87121
      • University of New Mexico Internal Medicine Clinic, Southwest Mesa
    • Belen, New Mexico, United States, 87002
      • First Choice Community Healthcare - Belen Medical Center
    • Edgewood, New Mexico, United States, 87015
      • First Choice Community Healthcare - Edgewood Medical/Dental Center
    • Lordsburg, New Mexico, United States, 88045
      • Hidalgo Medical Services - Lordsburg Clinic
    • Los Lunas, New Mexico, United States, 87031
      • First Choice Community Healthcare - Los Lunas Medical/Dental Center
    • Silver City, New Mexico, United States, 88061
      • Hidalgo Medical Services - Community Health Center
    • Silver City, New Mexico, United States, 88061
      • Hidalgo Medical Services - Med Square Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients in this arm will receive enhanced usual care.
Experimental: Collaborative Care; Intervention is administered to patients in this arm. Care to be delivered via collaborative care.	Behavioral: Collaborative Care; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol use severity	10-item AUDIT for past 3 months; assessed as a covariate; obtained from patient interview	Assessed over the previous 3 months at study entry
Current MDD/PTSD treatment	NSDUH items; assessed as a covariate; obtained from patient interview	Assessed over the previous 30 days at study entry
Prior experience with a care coordinator	Assessed as a covariate; obtained from patient interview	Assessed over the previous 12 months at study entry
Disability and impairment	3-item Sheehan Disability Scale; assessed as a covariate; obtained from patient interview	Assessed over the previous 7 days at study entry
Ability to access treatment quickly	AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at 3 months after study entry
Satisfaction with treatment	AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at 3 months after study entry
Demographics	Sex, race, ethnicity, education level; assessed as moderators; obtained from patient interview	Asked about present state at time of measurement; assessed at study entry
History of MOUD treatment	Assessed as a covariate; obtained from patient interview	Asked about lifetime MOUD treatment; assessed at study entry
Interpersonal support	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	Asked about present state at time of measurement; assessed at study entry
Legal involvement	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
Patient-care manager working alliance	Modified Working Alliance Inventory-General Practitioner (WAI-GP); assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at 3 months after study entry
Opioid overdose risk behaviors	Opioid Overdose Risk Assessment; obtained from patient interview; assessed as a covariate	Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
MDD remission	PHQ-9 score < 9; obtained from patient interview; assessed as a covariate	Assessed over the previous 2 weeks at 3 and 6 months after study entry
MDD response	PHQ-9 score < 50% of baseline score; obtained from patient interview; assessed as a covariate	Assessed over the previous 2 weeks at 3 and 6 months after study entry
PTSD remission	PCL-5 score < 34; obtained from patient interview; assessed as a covariate	Assessed over the previous 30 days at 3 and 6 months after study entry
PTSD response	PCL-5 score < 50% of baseline score; obtained from patient interview; assessed as a covariate	Assessed over the previous 30 days at 3 and 6 months after study entry
General health functioning	Veterans RAND 12-item Health Survey (VR-12); obtained from patient interview; analyzed as two component scores, mental and physical; assessed as a covariate	Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
Clinician (care coordinator) communication	Agency for Healthcare Research and Quality (AHRQ) Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview	Assessed over the previous 3 months at 3 months after study entry
Pain levels	Pain Intensity, Enjoyment of Life, General Activity (PEG) Pain Monitor for the past week; assessed as a covariate; obtained from patient interview	Assessed over the previous 7 days at study entry and at 3 and 6 months after study entry
Homelessness	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	Assessed over the previous 3 months at study entry
Rurality	Rural-Urban Commuting Area code associated with the participant's five-digit zip code; assessed as a moderator	Asked about present state at time of measurement; assessed at study entry

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: National Institute of Mental Health (NIMH); University of Pittsburgh; Boston Medical Center; Stanford University; University of New Mexico; Hidalgo Medical Services; First Choice Community Healthcare; Olive View-UCLA Education & Research Institute; Saint John's Cancer Institute
• Investigators: Principal Investigator: Miriam Komaromy, Boston Medical Center; Principal Investigator: Katherine Watkins, RAND

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Addiction; Collaborative care; Medication for addiction treatment; Problem solving therapy; Written exposure therapy; Opioid-use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Opioid-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: 1UF1MH121954 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: Per NIMH NDA policies (https://nda.nih.gov/)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No