Addiction, Depression, Opioid-use Disorder, Post Traumatic Stress Disorder, Suicidal Ideation
Conditions
Keywords
Collaborative care, Problem Solving Therapy, Written Exposure Therapy, Medication for addiction treatment, Addiction, Opioid use disorder, Suicide prevention, Overdose prevention
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.
Interventions
BEHAVIORALCollaborative 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.
Sponsors
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
Saint John's Cancer Institute
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two-arm randomized control trial (RCT) where participants are randomly assigned to intervention or control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| History of MOUD treatment | Asked about lifetime MOUD treatment; assessed at baseline | Assessed as a covariate; obtained from patient interview |
| Current Major Depressive Disorder (MDD)/PTSD treatment | Assessed over the previous 30 days at study entry | National Survey on Drug Use and Health (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 Government Performance and Results Act (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. |
| Demographics | Assessed at enrollment | Sex, race, ethnicity, education level; assessed as moderators; 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 | Agency for Healthcare Research and Quality (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 |
| 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 |
| 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 | Pain Intensity, Enjoyment of Life, General Activity (PEG) Pain Monitor for the past week; assessed as a covariate; obtained from patient interview |
Countries
United States
Outcome results
None listed