Collaborating to Heal Addiction and Mental Health in Primary Care

NCT ID: NCT04600414

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2024-08-31

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

Conditions

Opioid-use Disorder; Mental Health Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Collaborative Care for Mental Health Symptoms

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.

Group Type: ACTIVE_COMPARATOR

Collaborative Care for Mental Health Symptoms

Intervention Type: OTHER

CoCM is based on six key principles: 1) evidence-based, 2) measurement-based, 3) team-based, 4) population-based, 5) patient-centered, and 6) accountable. CoCM supports the delivery of evidence-based pharmacological and psychosocial treatments. CoCM is measurement-based with screening and monitoring of patient-reported outcomes over time to assess treatment response and facilitate treatment adjustments. CoCM is team-based led by a primary care provider with support from a care manager in consultation with a psychiatrist who provides treatment recommendations for patients who are not responding. CoCM is population-based whereby a registry is used to monitor treatment engagement and facilitate the identification of patients falling through the cracks. CoCM is patient-centered with proactive outreach to engage and activate patients. Collaborative care is accountable with continuous quality improvement to meet clinic performance benchmarks.

Collaborative Care for Opioid Use Disorder and Mental Health Symptoms

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.

Group Type: EXPERIMENTAL

Collaborative Care for Mental Health Symptoms

Intervention Type: OTHER

CoCM is based on six key principles: 1) evidence-based, 2) measurement-based, 3) team-based, 4) population-based, 5) patient-centered, and 6) accountable. CoCM supports the delivery of evidence-based pharmacological and psychosocial treatments. CoCM is measurement-based with screening and monitoring of patient-reported outcomes over time to assess treatment response and facilitate treatment adjustments. CoCM is team-based led by a primary care provider with support from a care manager in consultation with a psychiatrist who provides treatment recommendations for patients who are not responding. CoCM is population-based whereby a registry is used to monitor treatment engagement and facilitate the identification of patients falling through the cracks. CoCM is patient-centered with proactive outreach to engage and activate patients. Collaborative care is accountable with continuous quality improvement to meet clinic performance benchmarks.

Collaborative Care for Opioid Use Disorder and Mental Health Symptoms

Intervention Type: OTHER

Pharmacologic treatment of OUD will rely mainly on transmucosal buprenorphine/naloxone prescribed by primary care providers with DATA 2000 waivers. Measurement-based care and "treat to target" are fundamental principles of CoCM and will be incorporated into the intervention. Care managers will ask four yes/no questions about: 1) opioid withdrawal symptoms, 2) illicit opioid craving, 3) illicit opioid use, 4) medication side effects. If necessary, consulting psychiatrists will then recommend a change to the treatment plan to the primary care provider. In the case of buprenorphine/naloxone, options for changing the treatment plan include: 1) increasing the dosage (max dose 32mg), 2) augmenting with clonidine, 3) switching to injectable buprenorphine, and/or 4) intensifying psychosocial interventions. If the patient is experiencing medication side effects, but not opioid withdrawal symptoms or illicit opioid craving, consideration will be given to lowering the medication dosage.

Interventions

Collaborative Care for Mental Health Symptoms

CoCM is based on six key principles: 1) evidence-based, 2) measurement-based, 3) team-based, 4) population-based, 5) patient-centered, and 6) accountable. CoCM supports the delivery of evidence-based pharmacological and psychosocial treatments. CoCM is measurement-based with screening and monitoring of patient-reported outcomes over time to assess treatment response and facilitate treatment adjustments. CoCM is team-based led by a primary care provider with support from a care manager in consultation with a psychiatrist who provides treatment recommendations for patients who are not responding. CoCM is population-based whereby a registry is used to monitor treatment engagement and facilitate the identification of patients falling through the cracks. CoCM is patient-centered with proactive outreach to engage and activate patients. Collaborative care is accountable with continuous quality improvement to meet clinic performance benchmarks.

Intervention Type: OTHER

Collaborative Care for Opioid Use Disorder and Mental Health Symptoms

Pharmacologic treatment of OUD will rely mainly on transmucosal buprenorphine/naloxone prescribed by primary care providers with DATA 2000 waivers. Measurement-based care and "treat to target" are fundamental principles of CoCM and will be incorporated into the intervention. Care managers will ask four yes/no questions about: 1) opioid withdrawal symptoms, 2) illicit opioid craving, 3) illicit opioid use, 4) medication side effects. If necessary, consulting psychiatrists will then recommend a change to the treatment plan to the primary care provider. In the case of buprenorphine/naloxone, options for changing the treatment plan include: 1) increasing the dosage (max dose 32mg), 2) augmenting with clonidine, 3) switching to injectable buprenorphine, and/or 4) intensifying psychosocial interventions. If the patient is experiencing medication side effects, but not opioid withdrawal symptoms or illicit opioid craving, consideration will be given to lowering the medication dosage.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

John Cooper Fortney

Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Fortney, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Unity Health Care Minnesota Avenue Health Center

Washington D.C., District of Columbia, United States

Unity Health Care Anacostia Health Center

Washington D.C., District of Columbia, United States

Emory University Hospital Midtown-Radiology

Atlanta, Georgia, United States

Emory Clinic at Saint Joseph's - Primary Care

Atlanta, Georgia, United States

Emory at Dunwoody - Family Medicine

Dunwoody, Georgia, United States

Emory at Rockbridge - Primary Care & Nephrology

Stone Mountain, Georgia, 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

Kootenai Clinic Family Medicine Post Falls

Post Falls, Idaho, United States

Minooka Healthcare Center - Ridge Road Campus

Channahon, Illinois, United States

Oak Street Health Madison St.

Chicago, Illinois, United States

Oak Street Health Hermosa

Chicago, Illinois, United States

Gardner Healthcare Center of Morris Hospital

Gardner, Illinois, United States

Minooka Healthcare Center of Morris Hospital - Mondamin St.

Minooka, Illinois, 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

Oak Street Health Gary Primary Care Clinic

Gary, Indiana, United States

Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates

Beverly, Massachusetts, United States

Beth Israel Deaconess HealthCare-Chelsea

Chelsea, Massachusetts, United States

Berkshire Hillcrest Family Health Center

Pittsfield, Massachusetts, United States

Berkshire Williamstown Medical

Williamstown, Massachusetts, United States

OneWorld Community Health Centers Livestock Exchange

Omaha, Nebraska, United States

OneWorld Community Health Centers Northwest

Omaha, Nebraska, United States

Oak Street Health Pleasant Grove Primary Care Clinic

Dallas, Texas, 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

Northshore Medical Group Stevenson

Stevenson, Washington, United States

PeaceHealth Family Medicine of Southwest Washington

Vancouver, Washington, United States

Peace Health Fisher's Landing

Vancouver, Washington, United States

Northshore Medical Group White Salmon

White Salmon, Washington, United States

UW Health Yahara Clinic

Monona, Wisconsin, United States

UW Health Deforest-Windsor Clinic

Windsor, Wisconsin, United States

Countries

United States

References

Fortney JC, Ratzliff AD, Blanchard BE, Ferro L, Chase E, Rouvere J, Duncan MH, Merrill JO, Simpson T, Williams EC, Austin EJ, Curran GM, Schoenbaum M, Heagerty PJ, Saxon AJ. Collaborative Care for Opioid Use Disorder in Primary Care: A Hybrid Type 2 Cluster Randomized Clinical Trial. JAMA Psychiatry. 2025 Oct 1;82(10):956-966. doi: 10.1001/jamapsychiatry.2025.2126.

Reference Type: DERIVED

PMID: 40833733 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UF1MH121942

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SITE00000376

Identifier Type: -

Identifier Source: org_study_id