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

Sponsor

RAND (Other)

Overall Status

Recruiting

CT.gov ID

NCT04559893

Collaborator

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

900

Enrollment

Locations

Arms

35.7

Anticipated Duration (Months)

56.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder Addiction Depression Post-traumatic Stress Disorder	Behavioral: Collaborative Care	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two-arm RCT where participants are randomly assigned to intervention or control.Two-arm RCT where participants are randomly assigned to intervention or control.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 8, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Collaborative Care Intervention is administered to patients in this arm. Care to be delivered via collaborative care.	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.
No Intervention: Control Patients in this arm will receive enhanced usual care.

Arm

Intervention/Treatment

Experimental: Collaborative Care

Intervention is administered to patients in this arm. Care to be delivered via collaborative care.

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.

No Intervention: Control

Patients in this arm will receive enhanced usual care.

Outcome Measures

Primary Outcome Measures

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
MOUD access [Assessed over the first 30 days after study entry]
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
MDD symptoms [Assessed over the previous 2 weeks at study entry and at 3 and 6 months after study entry]
PHQ-9 (change in raw score from baseline); obtained from patient interview
PTSD symptoms [Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry]
PCL-5 (change in raw score from baseline); obtained from patient interview

Secondary Outcome Measures

Drug use frequency [Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry]
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
Opioid use severity [Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry]
7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Substance Use Short Form for the previous 30 days; obtained from patient interview
Alcohol use frequency [Assessed over the previous 3 months at study entry and at 3 and 6 months after study entry]
3-item Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) for the previous 3 months; obtained from patient interview
Opioid overdose events [Assessed over the previous 3 months at study entry and at 3 and 6 months after study entry]
Naloxone Overdose Baseline Questionnaire for past 3 months; obtained from patient interview
Suicidality [Assessed over the previous 30 days at 3 and 6 months after study entry]
Columbia Suicide Severity Rating Scales, analyzed as a continuous measure using a related Classification Algorithm; obtained from patient interview
All-cause mortality [Assessed over the first 180 days after study entry]
Mortality as reported in National Death Index
MOUD initiation [Assessed over the first 14 days after study entry]
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
MOUD engagement [Assessed over the first 34 days after study entry]
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
Access to MDD and/or PTSD treatment [Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry]
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
Quality of care for MDD [Assessed over the first 12 weeks after study entry]
4 psychotherapy visits in the first 8 weeks or an adequate (12-week) medication trial; obtained from EHR
Quality of care for PTSD [Assessed over the first 60 days after study entry]
4 psychotherapy visits in the first 8 weeks or an adequate (60-day) medication trial; obtained from EHR

Other Outcome Measures

Demographics [Asked about present state at time of measurement; assessed at study entry]
Sex, race, ethnicity, education level; assessed as moderators; obtained from patient interview
Alcohol use severity [Assessed over the previous 3 months at study entry]
10-item AUDIT for past 3 months; assessed as a covariate; obtained from patient interview
Pain levels [Assessed over the previous 7 days at study entry and at 3 and 6 months after study entry]
PEG Pain Monitor for the past week; assessed as a covariate; obtained from patient interview
History of MOUD treatment [Asked about lifetime MOUD treatment; assessed at study entry]
Assessed as a covariate; obtained from patient interview
Current MDD/PTSD treatment [Assessed over the previous 30 days at study entry]
NSDUH items; assessed as a covariate; obtained from patient interview
Prior experience with a care coordinator [Assessed over the previous 12 months at study entry]
Assessed as a covariate; obtained from patient interview
Interpersonal support [Asked about present state at time of measurement; assessed at study entry]
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
Homelessness [Assessed over the previous 3 months at study entry]
Homelessness Screening Clinical Reminder Tool and one item from the GPRA clarifying where individuals who are homeless are currently living; assessed as a mediator; obtained from patient interview
Legal involvement [Asked about lifetime legal involvement; assessed at study entry and at 3 and 6 months after study entry]
Items from the NSDUH and the Addiction Severity Index; assessed as a covariate; obtained from patient interview
Disability and impairment [Assessed over the previous 7 days at study entry]
3-item Sheehan Disability Scale; assessed as a covariate; obtained from patient interview
Rurality [Asked about present state at time of measurement; assessed at study entry]
Rural-Urban Commuting Area code associated with the participant's five-digit ZIP code; assessed as a moderator
Clinician (care coordinator) communication [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
Ability to access treatment quickly [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
Satisfaction with treatment [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
Patient-care manager working alliance [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
Opioid overdose risk behaviors [Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry]
Opioid Overdose Risk Assessment; obtained from patient interview; assessed as a covariate
MDD remission [Assessed over the previous 2 weeks at 3 and 6 months after study entry]
PHQ-9 score < 9; obtained from patient interview; assessed as a covariate
MDD response [Assessed over the previous 2 weeks at 3 and 6 months after study entry]
PHQ-9 score < 50% of baseline score; obtained from patient interview; assessed as a covariate
PTSD remission [Assessed over the previous 30 days at 3 and 6 months after study entry]
PCL-5 score < 34; obtained from patient interview; assessed as a covariate
PTSD response [Assessed over the previous 30 days at 3 and 6 months after study entry]
PCL-5 score < 50% of baseline score; obtained from patient interview; assessed as a covariate
General health functioning [Assessed over the previous 30 days at study entry and at 3 and 6 months after study entry]
Veterans RAND 12-item Health Survey (VR-12); obtained from patient interview; analyzed as two component scores, mental and physical; assessed as a covariate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hubert Humphrey Comprehensive Health Center	Los Angeles	California	United States	90003
2	Providence Saint John's Health Center	Santa Monica	California	United States	90404
3	First Choice Community Healthcare - South Broadway Medical Center	Albuquerque	New Mexico	United States	87102
4	First Choice Community Healthcare - South Valley Medical/Dental Center	Albuquerque	New Mexico	United States	87105
5	First Choice - Alameda Medical Center	Albuquerque	New Mexico	United States	87107
6	First Choice Community Healthcare - North Valley Medical Center	Albuquerque	New Mexico	United States	87107
7	University of New Mexico Family Health Clinic, North Valley	Albuquerque	New Mexico	United States	87107
8	University of New Mexico Family Health Clinic, Southeast Heights	Albuquerque	New Mexico	United States	87108
9	First Choice Community Healthcare - Alamosa Medical Center	Albuquerque	New Mexico	United States	87121
10	University of New Mexico Internal Medicine Clinic, Southwest Mesa	Albuquerque	New Mexico	United States	87121
11	First Choice Community Healthcare - Belen Medical Center	Belen	New Mexico	United States	87002
12	First Choice Community Healthcare - Edgewood Medical/Dental Center	Edgewood	New Mexico	United States	87015
13	Hidalgo Medical Services - Lordsburg Clinic	Lordsburg	New Mexico	United States	88045
14	First Choice Community Healthcare - Los Lunas Medical/Dental Center	Los Lunas	New Mexico	United States	87031
15	Hidalgo Medical Services - Community Health Center	Silver City	New Mexico	United States	88061
16	Hidalgo Medical Services - Med Square Clinic	Silver City	New Mexico	United States	88061