Collaborating to Heal Addiction and Mental Health in Primary Care

Not Applicable

Completed

• Conditions: Mental Health Disorder; Opioid-use Disorder
• Interventions: Other: Collaborative Care for Mental Health Disorders; Other: Collaborative Care for Opioid Use Disorder

• Registration Number: NCT04600414
• Lead Sponsor: University of Washington

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

Study Timeline

• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Study Start: 2020-11-20
• Primary Completion: 2024-02-15
• Study Completion: 2024-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collaborative Care for Mental Health Disorders	Collaborative Care for Mental Health Disorders	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.
Collaborative Care for Opioid Use Disorder	Collaborative Care for Opioid Use Disorder	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.
Collaborative Care for Opioid Use Disorder	Collaborative Care for Mental Health Disorders	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.

Primary Outcome Measures

Name	Time	Method
Illicit Opioid Use	6 months	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."
Change in Mental Health Functioning	6 Months	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)

Secondary Outcome Measures

Name	Time	Method
Medications for Opioid Use Disorder (MOUD) Persistence	6 months	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).
Change in Depression Symptoms	6 months	Change in Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse)
Change in Anxiety Symptoms	6 months	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)
Change in PTSD Symptoms	6 months	Change in PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse)

Trial Locations

Locations (33)

Unity Health Care Minnesota Avenue Health Center; 🇺🇸 Washington, District of Columbia, United States

Unity Health Care Anacostia Health Center; 🇺🇸 Washington, 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

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