Clinical trial NCT04600414: Collaborating to Heal Addiction and Mental Health in Primary Care
Official title: Collaborating to Heal Addiction and Mental Health in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Mental Health Disorder
Keywords: Primary Care
Collaborative Care
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Arkansas
name: Kaiser Permanente
First posted: 2020-10-23
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Trial. Clinics within healthcare systems are paired and randomized to intervention or control.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This multi-site study involves a sequence of trials (Pre-Post -\> Effectiveness -\> Implementation 3) to examine our primary, secondary and exploratory objectives.

1. Pre-Post trial (secondary objective) - Screening for Opioid User Disorder (OUD) will be integrated into Mental Health Disorder (MHD) screening and electronic health record (EHR) data will be used to determine if screening improves the detection of new cases of OUD during the first six months of the trial compared to the six months prior.
2. Cluster randomized Effectiveness trial (primary objective) - The primary objective of the trial is to test the effectiveness of delivering (Medication for OUD) MOUD in the context of Collaborative Care Management (CoCM) for MHD, hereafter termed the "intervention" compared to CoCM for MHD only hereafter termed the "control". All 24 sites have previously partnered with the AIMS Center to implement CoCM for MHD. After monitoring CoCM for MHD fidelity during a three month "run in" phase, the investigators will categorize clinics into one of two cohorts and then randomize them.

   * Cohort 1 (n=600) - Randomize clinics with high CoCM for MHD fidelity to sequentially adding MOUD for OUD (intervention group) or maintenance CoCM for MHD only (control group).
   * Cohort 2 (n=600) - Randomize clinics with low CoCM for MHD fidelity to simultaneous implementation of CoCM for MHD and OUD (intervention group ) or CoCM for MHD only (control group).
3. Cluster randomized Implementation trial (exploratory objective) - At the end of the Effectiveness trial, the intervention clinics will be randomized to receive a low-intensity or high-intensity implementation strategy to promote sustainability

Eligibility criteria: 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.

Primary outcomes:
measure: Illicit Opioid Use
timeFrame: 6 months
measure: Change in Mental Health Functioning
timeFrame: 6 Months
Secondary outcomes:
measure: Change in Depression Symptoms
timeFrame: 6 months
measure: Change in Anxiety Symptoms
timeFrame: 6 months
measure: Change in PTSD Symptoms
timeFrame: 6 months
measure: Medications for Opioid Use Disorder (MOUD) Persistence
timeFrame: 6 months
Other outcomes:
measure: Change in Access to Addiction Care for Opioid Use Disorder
timeFrame: 6 months
measure: Risk factors for premature mortality
timeFrame: 6 months
Locations:
city: Washington
country: United States
facility: Unity Health Care Minnesota Avenue Health Center
state: District of Columbia
city: Washington
country: United States
facility: Unity Health Care Anacostia Health Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown-Radiology
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic at Saint Joseph's - Primary Care
state: Georgia
city: Dunwoody
country: United States
facility: Emory at Dunwoody - Family Medicine
state: Georgia
city: Stone Mountain
country: United States
facility: Emory at Rockbridge - Primary Care & Nephrology
state: Georgia
city: Coeur d'Alene
country: United States
facility: Kootenai Clinic Family Medicine Ironwood
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Clinic Family Medicine Residency
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Clinic Internal Medicine Coeur d'Alene
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Clinic Family Medicine Post Falls
state: Idaho
city: Channahon
country: United States
facility: Minooka Healthcare Center - Ridge Road Campus
state: Illinois
city: Chicago
country: United States
facility: Oak Street Health Madison St.
state: Illinois
city: Chicago
country: United States
facility: Oak Street Health Hermosa
state: Illinois
city: Gardner
country: United States
facility: Gardner Healthcare Center of Morris Hospital
state: Illinois
city: Minooka
country: United States
facility: Minooka Healthcare Center of Morris Hospital - Mondamin St.
state: Illinois
city: Morris
country: United States
facility: Morris Healthcare Center of Morris Hospital - Dresden Drive
state: Illinois
city: Oak Park
country: United States
facility: Oak Street Health Chicago Ave Primary Care Clinic
state: Illinois
city: Gary
country: United States
facility: Oak Street Health Gary Primary Care Clinic
state: Indiana
city: Beverly
country: United States
facility: Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates
state: Massachusetts
city: Chelsea
country: United States
facility: Beth Israel Deaconess HealthCare-Chelsea
state: Massachusetts
city: Pittsfield
country: United States
facility: Berkshire Hillcrest Family Health Center
state: Massachusetts
city: Williamstown
country: United States
facility: Berkshire Williamstown Medical
state: Massachusetts
city: Omaha
country: United States
facility: OneWorld Community Health Centers Livestock Exchange
state: Nebraska
city: Omaha
country: United States
facility: OneWorld Community Health Centers Northwest
state: Nebraska
city: Dallas
country: United States
facility: Oak Street Health Pleasant Grove Primary Care Clinic
state: Texas
city: Fort Worth
country: United States
facility: Oak Street Health Meadowbrook Primary Care Clinic
state: Texas
city: Fort Worth
country: United States
facility: Oak Street Health North Side Primary Care
state: Texas
city: Stevenson
country: United States
facility: Northshore Medical Group Stevenson
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Family Medicine of Southwest Washington
state: Washington
city: Vancouver
country: United States
facility: Peace Health Fisher's Landing
state: Washington
city: White Salmon
country: United States
facility: Northshore Medical Group White Salmon
state: Washington
city: Monona
country: United States
facility: UW Health Yahara Clinic
state: Wisconsin
city: Windsor
country: United States
facility: UW Health Deforest-Windsor Clinic
state: Wisconsin
Study officials:
affiliation: University of Washington
name: John Fortney, PhD
role: PRINCIPAL_INVESTIGATOR
References: