Competitive Revision for CLARO: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Suicidal Ideation; Addiction; Post Traumatic Stress Disorder; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Collaborative care Plus

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirsten Becker; Phone Number: 6480 310-393-0411; Email: becker@rand.org

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
    • 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
    • Los Lunas, New Mexico, United States, 87031
      • First Choice Community Healthcare - Los Lunas Medical/Dental Center

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
Experimental: 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.	Behavioral: Collaborative care Plus; 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 this model, the CC team also includes a behavioral health psychotherapist (BHP) who consults on a regular basis but does not deliver direct care. In the Collaborative Care Plus condition, the care coordinator involves family in care, teaches family about naloxone use, and provides Caring Contacts, a suicide prevention method, to patients.
No Intervention: Control; 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid overdose risk behaviors	Measured as a sum of ratings on 9 risk behaviors from Opioid Overdose Risk Assessment (score 0-36). A high score indicates high risk.	Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry
Suicide risk	Measured using Columbia Suicide Severity Rating Scales, classified into 6 levels (from no risk to suicide attempt)	Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Sex, race, ethnicity, education level; assessed as moderators; obtained from patient interview	Assessed at enrollment
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
History of MOUD treatment	Assessed as a covariate; obtained from patient interview	Asked about lifetime MOUD treatment; assessed at baseline
Prior experience with a care coordinator	Assessed as a covariate; obtained from patient interview	Assessed over the previous 12 months 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	Asked about present state at time of measurement; assessed at enrollment
Legal involvement	Items from the NSDUH and the Addiction Severity Index; assessed as a covariate; obtained from patient interview. The study team constructed a single measure from the items described. They will not be analyzed separately as two different measures.	Asked about lifetime legal involvement; assessed at baseline and at 3 and 6 months
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
Patient-care coordinator 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
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 enrollment and at 3 and 6 months
Current Major Depressive Disorder (MDD)/PTSD treatment	National Survey on Drug Use and Health (NSDUH) items; assessed as a covariate; obtained from patient interview	Assessed over the previous 30 days at 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. The study team constructed a single measure from the items described. They will not be analyzed separately as two different measures.	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 baseline
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

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: Katherine Watkins, MD, RAND; Principal Investigator: Miriam Komaromy, Boston Medical Center

Publications and helpful links

General Publications

• Fendrich M, Becker J, Hernandez-Meier J. Psychiatric symptoms and recent overdose among people who use heroin or other opioids: Results from a secondary analysis of an intervention study. Addict Behav Rep. 2019 Aug 6;10:100212. doi: 10.1016/j.abrep.2019.100212. eCollection 2019 Dec. Erratum In: Addict Behav Rep. 2021 Jan 21;13:100333.
• Ilgen MA, Bohnert AS, Ignacio RV, McCarthy JF, Valenstein MM, Kim HM, Blow FC. Psychiatric diagnoses and risk of suicide in veterans. Arch Gen Psychiatry. 2010 Nov;67(11):1152-8. doi: 10.1001/archgenpsychiatry.2010.129.
• Jones CM, McCance-Katz EF. Co-occurring substance use and mental disorders among adults with opioid use disorder. Drug Alcohol Depend. 2019 Apr 1;197:78-82. doi: 10.1016/j.drugalcdep.2018.12.030. Epub 2019 Feb 14.
• Moscicki EK, O'Carroll P, Rae DS, Locke BZ, Roy A, Regier DA. Suicide attempts in the Epidemiologic Catchment Area Study. Yale J Biol Med. 1988 May-Jun;61(3):259-68.
• 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): August 31, 2022
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Suicide prevention; Addiction; Collaborative care; Problem Solving Therapy; Written Exposure Therapy; Medication for addiction treatment; Opioid use disorder; Overdose prevention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Trauma and Stressor Related Disorders; Self-Injurious Behavior; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Suicide; Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Suicidal Ideation; Opioid-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: 3UF1MH121954-01S1 (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 identification, 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No