Collaboration Leading to Addiction Treatment and Recovery From Other Stresses
- Conditions
- AddictionOpioid-use DisorderDepressionPost-traumatic Stress Disorder
- Interventions
- Behavioral: Collaborative Care
- Registration Number
- NCT04559893
- Lead Sponsor
- RAND
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 729
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Collaborative Care Collaborative Care Intervention is administered to patients in this arm. Care to be delivered via collaborative care.
- Primary Outcome Measures
Name Time Method MOUD access Assessed over the first 30 days after study entry 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
Major Depressive Disorder (MDD) symptoms Assessed over the previous 2 weeks at study entry and at 3 and 6 months after study entry (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.
MOUD continuity of care Assessed over the first 180 days after study entry 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
Post-traumatic Stress Disorder (PTSD) symptoms Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry (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.
- Secondary Outcome Measures
Name Time Method Opioid overdose events Assessed over the previous 3 months at study entry and at 3 and 6 months after study entry Naloxone Overdose Baseline Questionnaire for past 3 months; obtained from patient interview
All-cause mortality Assessed over the first 180 days after study entry Mortality as reported in National Death Index
MOUD engagement Assessed over the first 34 days after study entry 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
Access to MDD and/or PTSD treatment Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry 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
Quality of care for PTSD Assessed over the first 60 days after study entry 4 psychotherapy visits in the first 8 weeks or an adequate (60-day) medication trial; obtained from EHR
Alcohol use frequency Assessed over the previous 3 months at study entry and at 3 and 6 months after study entry 3-item Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) for the previous 3 months; obtained from patient interview
Drug use frequency Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry 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
Opioid use severity Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry 7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Substance Use Short Form for the previous 30 days; obtained from patient interview
Suicidality Assessed over the previous 30 days at 3 and 6 months after study entry Columbia Suicide Severity Rating Scales, analyzed as a continuous measure using a related Classification Algorithm; obtained from patient interview
MOUD initiation Assessed over the first 14 days after study entry 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
Quality of care for MDD Assessed over the first 12 weeks after study entry 4 psychotherapy visits in the first 8 weeks or an adequate (12-week) medication trial; obtained from EHR
Trial Locations
- Locations (16)
Providence Saint John's Health Center
🇺🇸Santa Monica, California, United States
First Choice Community Healthcare - South Broadway Medical Center
🇺🇸Albuquerque, New Mexico, United States
Hubert Humphrey Comprehensive Health Center
🇺🇸Los Angeles, California, United States
First Choice - Alameda Medical Center
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Family Health Clinic, North Valley
🇺🇸Albuquerque, New Mexico, United States
First Choice Community Healthcare - Alamosa Medical Center
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Internal Medicine Clinic, Southwest Mesa
🇺🇸Albuquerque, New Mexico, United States
First Choice Community Healthcare - Belen Medical Center
🇺🇸Belen, New Mexico, United States
Hidalgo Medical Services - Lordsburg Clinic
🇺🇸Lordsburg, New Mexico, United States
First Choice Community Healthcare - Los Lunas Medical/Dental Center
🇺🇸Los Lunas, New Mexico, United States
First Choice Community Healthcare - Edgewood Medical/Dental Center
🇺🇸Edgewood, New Mexico, United States
Hidalgo Medical Services - Community Health Center
🇺🇸Silver City, New Mexico, United States
Hidalgo Medical Services - Med Square Clinic
🇺🇸Silver City, New Mexico, United States
First Choice Community Healthcare - South Valley Medical/Dental Center
🇺🇸Albuquerque, New Mexico, United States
First Choice Community Healthcare - North Valley Medical Center
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Family Health Clinic, Southeast Heights
🇺🇸Albuquerque, New Mexico, United States