Competitive Revision for CLARO: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses
- Conditions
- Post Traumatic Stress DisorderOpioid-use DisorderAddictionSuicidal IdeationDepression
- Interventions
- Behavioral: Collaborative care Plus
- Registration Number
- NCT04634279
- Lead Sponsor
- RAND
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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 Plus Collaborative care Plus 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Suicide risk Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry Measured using Columbia Suicide Severity Rating Scales, classified into 6 levels (from no risk to suicide attempt)
Opioid overdose risk behaviors Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry Measured as a sum of ratings on 9 risk behaviors from Opioid Overdose Risk Assessment (score 0-36). A high score indicates high risk.
Trial Locations
- Locations (12)
Hubert Humphrey Comprehensive Health Center
🇺🇸Los Angeles, California, United States
First Choice Community Healthcare - South Broadway Medical Center
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Family Health Clinic, Southeast Heights
🇺🇸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, North Valley
🇺🇸Albuquerque, New Mexico, United States
First Choice - Alameda Medical Center
🇺🇸Albuquerque, New Mexico, United States
First Choice Community Healthcare - Alamosa Medical Center
🇺🇸Albuquerque, New Mexico, United States
First Choice Community Healthcare - Edgewood Medical/Dental Center
🇺🇸Edgewood, New Mexico, United States
First Choice Community Healthcare - Los Lunas Medical/Dental Center
🇺🇸Los Lunas, New Mexico, United States
Providence Saint John's Health Center
🇺🇸Santa Monica, California, United States
First Choice Community Healthcare - South Valley Medical/Dental Center
🇺🇸Albuquerque, New Mexico, United States
First Choice Community Healthcare - Belen Medical Center
🇺🇸Belen, New Mexico, United States