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

• ClinicalTrials.gov Identifier: NCT04634279
• Recruitment Status: Active, not recruiting
• First Posted: November 18, 2020
• Last Update Posted: January 25, 2023
• Sponsor: RAND
• 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

Tracking Information

• First Submitted Date: November 2, 2020
• First Posted Date: November 18, 2020
• Last Update Posted Date: January 25, 2023
• Actual Study Start Date: August 31, 2022
• Estimated Primary Completion Date: February 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 12, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 12, 2020)

• 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.
• 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)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: November 12, 2020)

• Demographics [ Time Frame: Assessed at enrollment ]
  Sex, race, ethnicity, education level; assessed as moderators; obtained from patient interview
• 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
• 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
• History of MOUD treatment [ Time Frame: Asked about lifetime MOUD treatment; assessed at baseline ]
  Assessed as a covariate; obtained from patient interview
• 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
• 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
• 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
• 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.
• 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.
• 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
• 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
• 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
• 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
• 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
• 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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Competitive Revision for CLARO: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses
• Official Title: Competitive Revision for Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness
• 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).
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Opioid-use Disorder
• Addiction
• Depression
• Post Traumatic Stress Disorder
• Suicidal Ideation

Intervention

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.

Study Arms

• 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.
  Intervention: Behavioral: Collaborative care Plus
• No Intervention: Control
  Patients in this arm will receive enhanced usual care.

Publications *

• Fendrich M, Becker J, Hernandez-Meier J. Psychiatric symptoms and recent overdose among people who use heroin or other opioids: Results from a secondary analysis of an intervention study. Addict Behav Rep. 2019 Aug 6;10:100212. doi: 10.1016/j.abrep.2019.100212. eCollection 2019 Dec. Erratum In: Addict Behav Rep. 2021 Jan 21;13:100333.
• Ilgen MA, Bohnert AS, Ignacio RV, McCarthy JF, Valenstein MM, Kim HM, Blow FC. Psychiatric diagnoses and risk of suicide in veterans. Arch Gen Psychiatry. 2010 Nov;67(11):1152-8. doi: 10.1001/archgenpsychiatry.2010.129.
• Jones CM, McCance-Katz EF. Co-occurring substance use and mental disorders among adults with opioid use disorder. Drug Alcohol Depend. 2019 Apr 1;197:78-82. doi: 10.1016/j.drugalcdep.2018.12.030. Epub 2019 Feb 14.
• Moscicki EK, O'Carroll P, Rae DS, Locke BZ, Roy A, Regier DA. Suicide attempts in the Epidemiologic Catchment Area Study. Yale J Biol Med. 1988 May-Jun;61(3):259-68.
• Osilla KC, Dopp AR, Watkins KE, Ceballos V, Hurley B, Meredith LS, Leamon I, Jacobsohn V, Komaromy M. Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. Addict Sci Clin Pract. 2022 Apr 8;17(1):25. doi: 10.1186/s13722-022-00302-9.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 12, 2020): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 31, 2024
• Estimated Primary Completion Date: February 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04634279
• Other Study ID Numbers: 3UF1MH121954-01S1( U.S. NIH Grant/Contract ); 3UF1MH121954-01S1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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/

• Current Responsible Party: RAND
• Original Responsible Party: Same as current
• Current Study Sponsor: RAND
• Original Study Sponsor: Same as current

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

Investigators

• Principal Investigator: Katherine Watkins, MD; RAND
• Principal Investigator: Miriam Komaromy; Boston Medical Center

• PRS Account: RAND
• Verification Date: January 2023