NCT Number: NCT04559893
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hubert Humphrey Comprehensive Health Center, Los Angeles, California, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Assessed at 6 months after study entry.
Number of days until first buprenorphine prescription after study enrollment for study participants with a new episode of OUD care (no care for at least 30 days prior). Obtained from the Prescription Drug Monitoring Program and patient survey.
Time frame: Assessed at 6 months after study entry.
The cumulative number of days the patient receives buprenorphine during the 180 days after study enrollment for study participants not on methadone at baseline. Obtained from the Prescription Drug Monitoring Program and patient survey.
Time frame: Assessed at 6 months after study entry.
Sum of items (0-27) in the PHQ-9 (Patient Health Questionnaire) at 6 months for participants with probable major depression at baseline.
Time frame: Assessed at 6 months after study entry.
Sum of items (0-80) in PCL-5 at 6 months for study participants with probable PTSD at baseline.
Time frame: Assessed at 30 days and 180 days after study entry.
Receipt of medication and/or behavioral treatment associated with an MDD or PTSD diagnosis within 30 days of study enrollment (initial) or within 180 days of study enrollment (any) for study participants who did not have any visits (behavioral health treatment or medication) for MDD and/or PTSD in 30 days prior to study enrollment. Obtained from patient survey and electronic medical records.
Time frame: Assessed at 6 months after study entry.
Four psychotherapy visits in the first six months or an adequate (60 day) medication trial for new episodes of MDD care (completed within 6 months) for study participants with probable MDD at baseline and a new episode of MDD care (no MDD care for at least 30 days prior to enrollment). Obtained from patient survey and electronic medical records.
Time frame: Assessed at 6 months after study entry.
Four psychotherapy visits in the first six months or an adequate (60 days) medication trial for new episodes of PTSD care (completed within 6 months) for study participants with probable PTSD at baseline, and a new episode of PTSD care (no PTSD care for at least 30 days prior to enrollment). Obtained from patient survey and electronic medical records.
Time frame: Assessed at 6 months after study entry
Binary measure based on sum of items (0-27) in the PHQ-9. PHQ-9 score less than 5 at 6 months for study participants with probable MDD at baseline.
Time frame: Assessed at 6 months after study entry.
Binary measure based on sum of items (0-27) in the PHQ-9. PHQ-9 score at 6 months less than 50% of baseline score for participants with probable MDD at baseline.
Time frame: Assessed at 6 months after study entry.
Binary measure based on sum of items (0-80) in the PCL-5. PCL-5 score less than 34 at 6 months for study participants with probable PTSD at baseline.
Time frame: Assessed at 6 months after study entry.
Binary measure based on sum of items (0-80) in the PCL-5. PCL-5 score at 6 months less than 50% of baseline score for study participants with probable PTSD at baseline.
Time frame: Assessed at 6 months after study entry.
Dichotomized Columbia Suicide Severity Rating Scale at 6 months. Endorsed if participants answer YES to Question 3, 4, and/or 5 and/or YES to Question 7. Obtained from patient survey.
Time frame: Assessed over 30 days after study entry.
Days of opioid use in the past 30 days from National Survey on Drug Use and Health. Obtained from patient survey.
Time frame: Assessed over the previous 3 months after study entry.
Opioid overdose events (at least 1 event) in the previous three months. Obtained from patient survey.
Time frame: Assessed at 30 days after study entry
Physical health measured using the component scores from the Veterans RAND 12-item Health Survey (VR-12) physical health subscale.
Time frame: Assessed at 30 days after study entry
Mental health functioning measured using the component scores from the Veterans RAND 12-item Health Survey (VR-12) mental health subscale.
Time frame: Assessed over 30 days after study entry.
Maximum days of use in the past 30 days for five drug categories using items from National Survey on Drug Use and Health (prescription opioids, heroin, cocaine/crack, methamphetamine/ other stimulants, and tranquilizers/sedatives). Obtained from patient survey.
Time frame: Assessed over 30 days after study entry.
Days of stimulant use (cocaine/crack, methamphetamine/ other stimulants) in the past 30 days from the National Survey on Drug Use and Health. Obtained from patient survey.
Time frame: Assessed over 3 months after study entry.
Sum of items (0-12) in the Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) for the previous 3 months.
Time frame: Assessed over 3 months after study entry.
Sum of 32-items in the Opioid Overdose Risk Assessment.
Time frame: Assessed over 30 days after study entry.
Sum of items (7-35) in the Patient-Reported Outcomes Measurement Information System (PROMIS) Substance Use Short Form for the previous 30 days. Obtained from patient survey.
Time frame: Assessed at study entry.
Self-reported demographics on age, sex, race/ethnicity, educational attainment, and marital status.
Time frame: Assessed over the previous 7 days at study entry and at 3 and 6 months after study entry
Pain Intensity, Enjoyment of Life, General Activity (PEG) Pain Monitor for the past week; assessed as a covariate; obtained from patient interview
Time frame: Asked about lifetime MOUD treatment; assessed at study entry
Assessed as a covariate; obtained from patient interview
Time frame: Assessed over the previous 30 days at study entry
NSDUH items; assessed as a covariate; obtained from patient interview
Time frame: Assessed over the previous 12 months at study entry
Assessed as a covariate; obtained from patient interview
Time frame: Assessed over the previous 3 months at study entry
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
Time frame: Assessed over the previous 7 days at study entry
3-item Sheehan Disability Scale; assessed as a covariate; obtained from patient interview
Time frame: Assessed over the previous 3 months at 3 months after study entry
Agency for Healthcare Research and Quality (AHRQ) Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview
Time frame: Assessed over the previous 3 months at 3 months after study entry
AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview
Time frame: Assessed over the previous 3 months at 3 months after study entry
AHRQ Consumer Assessment of Healthcare Providers and Systems survey items; assessed as a mediator; obtained from patient interview
Time frame: Assessed over the previous 3 months at 3 months after study entry
Modified Working Alliance Inventory-General Practitioner (WAI-GP); assessed as a mediator; obtained from patient interview
RAND
Other
Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness
Acronym: CLARO
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