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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04634279
• Other study ID #: 3UF1MH121954-01S1
• Secondary ID: 3UF1MH121954-01S
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: March 31, 2026
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive
• Depression
• Opioid-Related Disorders
• Opioid-use Disorder
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance-Related Disorders
• Suicidal Ideation

Intervention

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.

Locations

Country	Name	City	State
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 - North Valley Medical Center	Albuquerque	New Mexico
United States	First Choice Community Healthcare - South Broadway Medical Center	Albuquerque	New Mexico
United States	First Choice Community Healthcare - South Valley Medical/Dental Center	Albuquerque	New Mexico
United States	University of New Mexico Family Health Clinic, North Valley	Albuquerque	New Mexico
United States	University of New Mexico Family Health Clinic, Southeast Heights	Albuquerque	New Mexico
United States	First Choice Community Healthcare - Belen Medical Center	Belen	New Mexico
United States	First Choice Community Healthcare - Edgewood Medical/Dental Center	Edgewood	New Mexico
United States	Hubert Humphrey Comprehensive Health Center	Los Angeles	California
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

Sponsors (10)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Sex, race, ethnicity, education level; assessed as moderators; obtained from patient interview	Assessed at enrollment
Other	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
Other	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
Other	History of MOUD treatment	Assessed as a covariate; obtained from patient interview	Asked about lifetime MOUD treatment; assessed at baseline
Other	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
Other	Prior experience with a care coordinator	Assessed as a covariate; obtained from patient interview	Assessed over the previous 12 months at study entry
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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