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

Sponsor

RAND (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04634279

Collaborator

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

300

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder Addiction Depression Post Traumatic Stress Disorder Suicidal Ideation	Behavioral: Collaborative care Plus	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 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:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

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.

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.

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

Secondary Outcome Measures

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

Other Outcome Measures

Demographics [Assessed at enrollment]
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 enrollment and at 3 and 6 months]
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 baseline]
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 enrollment]
Indicated by the patient identifying a support person with whom they interact and who does not have problematic opioid use;; obtained from patient interview
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. The study team constructed a single measure from the items described. They will not be analyzed separately as two different measures.
Legal involvement [Asked about lifetime legal involvement; assessed at baseline and at 3 and 6 months]
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.
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 baseline]
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 coordinator 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

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	First Choice Community Healthcare - Belen Medical Center	Belen	New Mexico	United States	87002
11	First Choice Community Healthcare - Edgewood Medical/Dental Center	Edgewood	New Mexico	United States	87015
12	First Choice Community Healthcare - Los Lunas Medical/Dental Center	Los Lunas	New Mexico	United States	87031