Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

Depression Clinical Trial

— CLARO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04559893
• Other study ID #: 1UF1MH121954
• Secondary ID: 1UF1MH121954
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 900
• Est. completion date: August 31, 2024
• Est. primary completion date: February 1, 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

Intervention

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.

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	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	First Choice Community Healthcare - Edgewood Medical/Dental Center	Edgewood	New Mexico
United States	Hidalgo Medical Services - Lordsburg Clinic	Lordsburg	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
United States	Hidalgo Medical Services - Community Health Center	Silver City	New Mexico
United States	Hidalgo Medical Services - Med Square Clinic	Silver City	New Mexico

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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 study entry and at 3 and 6 months after study entry
Other	History of MOUD treatment	Assessed as a covariate; obtained from patient interview	Asked about lifetime MOUD treatment; assessed at study entry
Other	Current MDD/PTSD treatment	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; assessed as a covariate	Asked about present state at time of measurement; assessed at study entry
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	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	Asked about lifetime legal involvement; assessed at study entry and at 3 and 6 months after study entry
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 study entry
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 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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	All-cause mortality	Mortality as reported in National Death Index	Assessed over the first 180 days after study entry
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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