Collaborating to Heal Addiction and Mental Health in Primary Care — CHAMP  

Opioid-use Disorder Clinical Trial

Official title: Collaborating to Heal Addiction and Mental Health in Primary Care

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder
• Opioid-Related Disorders
• Opioid-use Disorder

• NCT number: NCT04600414
• Study type: Interventional
• Source: University of Washington
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2020
• Completion date: August 31, 2024