Opioid-use Disorder Clinical Trial
— CHAMPOfficial title:
Collaborating to Heal Addiction and Mental Health in Primary Care
Verified date | May 2024 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The gold-standard intervention for Opioid Use Disorder (OUD) is Medication for Opioid Use Disorder (MOUD). Because more patients with OUD need access to MOUD in primary care, the investigators are testing whether the Collaborative Care model (CoCM) is effective at treating both mental health disorders (MHD) and OUD concurrently in primary care settings. The intervention is CoCM for MHD and OUD. The active control is CoCM for MHD, but not treating OUD. The primary objective is to compare patient-reported outcomes in the intervention and control groups, and will be tested with in an Effectiveness trial. The secondary objective is to compare the detection of OUD pre- versus post-OUD screening implementation, and will be tested using a Pre-Post trial design. The exploratory objective is to compare intervention clinics randomized to a low-intensity sustainability implementation strategy or a high-intensity sustainability strategy, and will be tested in an Implementation trial.
Status | Active, not recruiting |
Enrollment | 1200 |
Est. completion date | August 31, 2024 |
Est. primary completion date | February 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Screen positive on the NIDA-ASSIST OUD items or referred to the trial by one of the clinic's providers AND 2. Meet clinical criteria for =2 symptoms of OUD on the DSM-5 checklist (administered by a clinician) AND 3. Screen positive for depression on the PHQ-9 (= 5) OR generalized anxiety on the GAD-7 (= 5) OR PTSD on the PC-PTSD-5 (= 1) within past 6 months. Exclusion Criteria: 1. Patient is being prescribed psychotropic medication (including MOUD) by a Mental Health Care Specialist (typically practicing in a specialty addiction treatment setting). 2. Patient is receiving or prefers to seek OUD treatment in specialty care setting including opioid treatment programs 3. Patient does not speak English or Spanish 4. Patient is younger than 18 years of age 5. Patient has a diagnosis of dementia 6. Patient lacks the capacity to provide informed consent 7. Patient doesn't plan on getting care at the clinic for the next 6 months. |
Country | Name | City | State |
---|---|---|---|
United States | Emory Clinic at Saint Joseph's - Primary Care | Atlanta | Georgia |
United States | Emory University Hospital Midtown-Radiology | Atlanta | Georgia |
United States | Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates | Beverly | Massachusetts |
United States | Minooka Healthcare Center - Ridge Road Campus | Channahon | Illinois |
United States | Beth Israel Deaconess HealthCare-Chelsea | Chelsea | Massachusetts |
United States | Oak Street Health Hermosa | Chicago | Illinois |
United States | Oak Street Health Madison St. | Chicago | Illinois |
United States | Kootenai Clinic Family Medicine Ironwood | Coeur d'Alene | Idaho |
United States | Kootenai Clinic Family Medicine Residency | Coeur d'Alene | Idaho |
United States | Kootenai Clinic Internal Medicine Coeur d'Alene | Coeur d'Alene | Idaho |
United States | Oak Street Health Pleasant Grove Primary Care Clinic | Dallas | Texas |
United States | Emory at Dunwoody - Family Medicine | Dunwoody | Georgia |
United States | Oak Street Health Meadowbrook Primary Care Clinic | Fort Worth | Texas |
United States | Oak Street Health North Side Primary Care | Fort Worth | Texas |
United States | Gardner Healthcare Center of Morris Hospital | Gardner | Illinois |
United States | Oak Street Health Gary Primary Care Clinic | Gary | Indiana |
United States | Minooka Healthcare Center of Morris Hospital - Mondamin St. | Minooka | Illinois |
United States | UW Health Yahara Clinic | Monona | Wisconsin |
United States | Morris Healthcare Center of Morris Hospital - Dresden Drive | Morris | Illinois |
United States | Oak Street Health Chicago Ave Primary Care Clinic | Oak Park | Illinois |
United States | OneWorld Community Health Centers Livestock Exchange | Omaha | Nebraska |
United States | OneWorld Community Health Centers Northwest | Omaha | Nebraska |
United States | Berkshire Hillcrest Family Health Center | Pittsfield | Massachusetts |
United States | Kootenai Clinic Family Medicine Post Falls | Post Falls | Idaho |
United States | Northshore Medical Group Stevenson | Stevenson | Washington |
United States | Emory at Rockbridge - Primary Care & Nephrology | Stone Mountain | Georgia |
United States | Peace Health Fisher's Landing | Vancouver | Washington |
United States | PeaceHealth Family Medicine of Southwest Washington | Vancouver | Washington |
United States | Unity Health Care Anacostia Health Center | Washington | District of Columbia |
United States | Unity Health Care Minnesota Avenue Health Center | Washington | District of Columbia |
United States | Northshore Medical Group White Salmon | White Salmon | Washington |
United States | Berkshire Williamstown Medical | Williamstown | Massachusetts |
United States | UW Health Deforest-Windsor Clinic | Windsor | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Kaiser Permanente, National Institute of Mental Health (NIMH), University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Access to Addiction Care for Opioid Use Disorder | Change in Perceived access to care will be measured from self report using the Assessment of Perceived Access to Care (APAC) instrument (range 1-5, higher scores are better) | 6 months | |
Other | Risk factors for premature mortality | Risk factors will include self-reported intent on self-harm, self-reported overdose, self-reported discontinuation of medications for opioid use disorder and the following adverse events reports: overdose, suicide attempt, hospitalization and ER admission. | 6 months | |
Primary | Illicit Opioid Use | Illicit opioid use will be measured from self-report using Opioid use will be measured using item 7E from the Brief Addiction Monitor (BAM) with the following preamble: "The next question asks about your use of street opioids and use of prescription opioids that were not prescribed to you by a healthcare provider. In the past 30 days, how many days did you use opiates such as Heroin, Morphine, Dilaudid, Demerol, Oxycontin, oxy, codeine (e.g., Tylenol 2,3,4), Percocet, Vicodin, Fentanyl, etc.? Do not count times you used buprenorphine, suboxone, or methadone as directed by a healthcare provider." | 6 months | |
Primary | Change in Mental Health Functioning | Change in Mental health functioning will be measured from self-report using the Mental Health Component Summary Score from the SF12V (range 0-100, higher scores are better) | 6 Months | |
Secondary | Change in Depression Symptoms | Change in Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse) | 6 months | |
Secondary | Change in Anxiety Symptoms | Change in Anxiety symptoms will be measured from self report using the PROMIS Measure - Emotional Distress, Anxiety, Short Form 7a (range 0-100, higher scores are worse) | 6 months | |
Secondary | Change in PTSD Symptoms | Change in PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse) | 6 months | |
Secondary | Medications for Opioid Use Disorder (MOUD) Persistence | MOUD persistence will be measured from self report and specified as the ratio of the number of days the study participant reported taking the MOUD medication (numerator) to the number of days during the 6-month follow-up period for which it was prescribed (denominator). | 6 months |
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