Collaborating to Heal Addiction and Mental Health in Primary Care (CHAMP)

University of Washington

Status: Completed

Conditions: Opioid-use Disorder; Mental Health Disorder

Treatments: Other: Collaborative Care for Opioid Use Disorder; Other: Collaborative Care for Mental Health Disorders

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04600414

UF1MH121942 (U.S. NIH Grant/Contract)

SITE00000376

Details and patient eligibility

About

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.

Full 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

Enrollment: 254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

254 participants in 2 patient groups

Collaborative Care for Mental Health Disorders

Active Comparator group

Description:

Collaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for mental health disorders.

Treatment:

Other: Collaborative Care for Mental Health Disorders

Collaborative Care for Opioid Use Disorder

Experimental group

Description:

Collaborative Care Management is an integrated care model that operationalizes the principles of the chronic care model to improve access to evidence-based treatments for opioid use disorder.

Treatment:

Other: Collaborative Care for Mental Health Disorders

Other: Collaborative Care for Opioid Use Disorder