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Collaboration Leading to Addiction Treatment and Recovery From Other Stresses (CLARO)

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ClinicalTrials.gov Identifier: NCT04559893
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : January 26, 2021
Sponsor:
Collaborators:
University of New Mexico
Boston Medical Center
First Choice Community Healthcare
Hidalgo Medical Services
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Katherine Watkins, RAND

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 Not Applicable

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 13 rural and urban primary care clinics located in Health Professional Shortage Areas (HPSA) of New Mexico to adapt, harmonize and then test whether CCCOD 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : January 8, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : January 2024

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.



Primary Outcome Measures :
  1. MOUD continuity of care [ Time Frame: 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

  2. MOUD access [ Time Frame: 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

  3. MDD symptoms [ Time Frame: 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

  4. PTSD symptoms [ Time Frame: 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 :
  1. Drug use frequency [ Time Frame: 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

  2. Opioid use severity [ Time Frame: 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

  3. Alcohol use [ Time Frame: 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

  4. Opioid overdose risk behaviors [ Time Frame: 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

  5. Opioid overdose events [ Time Frame: 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

  6. MDD remission [ Time Frame: Assessed over the previous 2 weeks at 3 and 6 months after study entry ]
    PHQ-9 score < 9; obtained from patient interview

  7. MDD response [ Time Frame: 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

  8. PTSD remission [ Time Frame: Assessed over the previous 30 days at 3 and 6 months after study entry ]
    PCL-5 score < 34; obtained from patient interview

  9. PTSD response [ Time Frame: 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

  10. Suicidality [ Time Frame: 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

  11. All-cause mortality [ Time Frame: Assessed over the first 180 days after study entry ]
    Mortality as reported in National Death Index

  12. MOUD initiation [ Time Frame: 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

  13. MOUD engagement [ Time Frame: 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

  14. Access to MDD and/or PTSD treatment [ Time Frame: 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

  15. Quality of care for MDD [ Time Frame: 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

  16. Quality of care for PTSD [ Time Frame: 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

  17. General health functioning [ Time Frame: 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


Other Outcome Measures:
  1. Demographics [ Time Frame: Asked about present state at time of measurement; assessed at study entry ]
    Sex, race, ethnicity, education level; assessed as moderators; obtained from patient interview

  2. Alcohol use severity [ Time Frame: Assessed over the previous 3 months at study entry ]
    10-item AUDIT for past 3 months; assessed as a covariate; obtained from patient interview

  3. Pain levels [ Time Frame: 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

  4. History of MOUD treatment [ Time Frame: Asked about lifetime MOUD treatment; assessed at study entry ]
    Assessed as a covariate; obtained from patient interview

  5. Current MDD/PTSD treatment [ Time Frame: Assessed over the previous 30 days at study entry ]
    NSDUH items; assessed as a covariate; obtained from patient interview

  6. Prior experience with a care coordinator [ Time Frame: Assessed over the previous 12 months at study entry ]
    Assessed as a covariate; obtained from patient interview

  7. Interpersonal support [ Time Frame: 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

  8. Homelessness [ Time Frame: 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

  9. Legal involvement [ Time Frame: 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

  10. Disability and impairment [ Time Frame: Assessed over the previous 7 days at study entry ]
    3-item Sheehan Disability Scale; assessed as a covariate; obtained from patient interview

  11. Rurality [ Time Frame: 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

  12. Clinician (care coordinator) communication [ 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

  13. Ability to access treatment quickly [ 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

  14. Satisfaction with treatment [ 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

  15. Patient-care manager working alliance [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 and older
  • Receiving primary care at one of the 11 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559893


Contacts
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Contact: Lina Tarhuni, MPH 505-272-1817 ltarhuni@salud.unm.edu
Contact: Kimberly A Page, PhD, MPH 505-272-2520 pagek@salud.unm.edu

Locations
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United States, New Mexico
First Choice Community Healthcare - South Broadway Medical Center Recruiting
Albuquerque, New Mexico, United States, 87102
First Choice Community Healthcare - South Valley Medical/Dental Center Recruiting
Albuquerque, New Mexico, United States, 87105
First Choice Community Healthcare - North Valley Medical Center Recruiting
Albuquerque, New Mexico, United States, 87107
University of New Mexico Family Health Clinic, North Valley Not yet recruiting
Albuquerque, New Mexico, United States, 87107
University of New Mexico Family Health Clinic, Southeast Heights Recruiting
Albuquerque, New Mexico, United States, 87108
First Choice Community Healthcare - Alamosa Medical Center Recruiting
Albuquerque, New Mexico, United States, 87121
University of New Mexico Internal Medicine Clinic, Southwest Mesa Not yet recruiting
Albuquerque, New Mexico, United States, 87121
First Choice Community Healthcare - Belen Medical Center Recruiting
Belen, New Mexico, United States, 87002
First Choice Community Healthcare - Edgewood Medical/Dental Center Recruiting
Edgewood, New Mexico, United States, 87015
Hidalgo Medical Services - Lordsburg Clinic Recruiting
Lordsburg, New Mexico, United States, 88045
First Choice Community Healthcare - Los Lunas Medical/Dental Center Recruiting
Los Lunas, New Mexico, United States, 87031
Hidalgo Medical Services - Community Health Center Recruiting
Silver City, New Mexico, United States, 88061
Hidalgo Medical Services - Med Square Clinic Recruiting
Silver City, New Mexico, United States, 88061
Sponsors and Collaborators
RAND
University of New Mexico
Boston Medical Center
First Choice Community Healthcare
Hidalgo Medical Services
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Katherine Watkins RAND
Principal Investigator: Miriam Komaromy Boston Medical Center
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Responsible Party: Katherine Watkins, Senior Physician Policy Researcher, RAND
ClinicalTrials.gov Identifier: NCT04559893    
Other Study ID Numbers: 1UF1MH121954 ( U.S. NIH Grant/Contract )
1UF1MH121954 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per NIMH funding requirements, study data must be uploaded to the NIMH National Data Archive (NDA) every six months once data collection begins. A universal subject ID (Global Unique Identifier, "GUID") will be generated for each participant. All raw data will be uploaded every six months to the NIMH NDA per their policies. Additionally, all analysis data sets used for manuscripts must be uploaded to the NIMH NDA, identified by GUID.
Time Frame: Every 6 months (January and July) following enrollment of the first patient. First submission expected July 2021. Submission will cease following sharing of final analysis data set for any specified outcomes publications.
Access Criteria: Per NIMH NDA policies (https://nda.nih.gov/)
URL: https://nda.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine Watkins, RAND:
Collaborative care
Problem solving therapy
Written exposure therapy
Medication for addiction treatment
Addiction
Opioid-use disorder
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Stress Disorders, Traumatic
Behavior, Addictive
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders