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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04634279
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : October 28, 2022
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of New Mexico
Boston Medical Center
Hidalgo Medical Services
First Choice Community Healthcare
Stanford University
University of Pittsburgh
Olive View-UCLA Education & Research Institute
Providence Saint John's Health Center
Information provided by (Responsible Party):
RAND

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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: Competitive Revision for Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness
Actual Study Start Date : August 31, 2022
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.



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


Secondary Outcome Measures :
  1. Opioid overdose risk behaviors [ Time Frame: 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.

  2. Suicide risk [ Time Frame: 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:
  1. Demographics [ Time Frame: Assessed at enrollment ]
    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 enrollment and at 3 and 6 months ]
    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 baseline ]
    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 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

  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. The study team constructed a single measure from the items described. They will not be analyzed separately as two different measures.

  9. Legal involvement [ Time Frame: 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.

  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 baseline ]
    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 coordinator 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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

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): NCT04634279


Contacts
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Contact: Kirsten Becker 310-393-0411 ext 6480 becker@rand.org

Locations
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United States, California
Hubert Humphrey Comprehensive Health Center Not yet recruiting
Los Angeles, California, United States, 90003
Providence Saint John's Health Center Not yet recruiting
Santa Monica, California, United States, 90404
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 - Alameda Medical Center Recruiting
Albuquerque, New Mexico, United States, 87107
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
Contact: Valerie Carrejo       vcarrejo@salud.unm.edu   
University of New Mexico Family Health Clinic, Southeast Heights Not yet recruiting
Albuquerque, New Mexico, United States, 87108
First Choice Community Healthcare - Alamosa Medical Center 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
First Choice Community Healthcare - Los Lunas Medical/Dental Center Recruiting
Los Lunas, New Mexico, United States, 87031
Sponsors and Collaborators
RAND
National Institute of Mental Health (NIMH)
University of New Mexico
Boston Medical Center
Hidalgo Medical Services
First Choice Community Healthcare
Stanford University
University of Pittsburgh
Olive View-UCLA Education & Research Institute
Providence Saint John's Health Center
Investigators
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Principal Investigator: Katherine Watkins, MD RAND
Principal Investigator: Miriam Komaromy Boston Medical Center
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT04634279    
Other Study ID Numbers: 3UF1MH121954-01S1 ( U.S. NIH Grant/Contract )
3UF1MH121954-01S1 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022
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: http://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 RAND:
Collaborative care
Problem Solving Therapy
Written Exposure Therapy
Medication for addiction treatment
Addiction
Opioid use disorder
Suicide prevention
Overdose prevention
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Substance-Related Disorders
Stress Disorders, Traumatic
Behavior, Addictive
Stress Disorders, Post-Traumatic
Suicidal Ideation
Pathologic Processes
Behavioral Symptoms
Trauma and Stressor Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Narcotic-Related Disorders
Chemically-Induced Disorders
Suicide
Self-Injurious Behavior