Collaborating to Heal Addiction and Mental Health in Primary Care

Opioid-use Disorder Clinical Trial

— CHAMP  

Official title:

Collaborating to Heal Addiction and Mental Health in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04600414
• Other study ID #: SITE00000376
• Secondary ID: UF1MH121942
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: August 31, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Collaborative Care for Mental Health Disorders
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
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.

Locations

Country	Name	City	State
United States	Emory Clinic at Saint Joseph's - Primary Care	Atlanta	Georgia
United States	Emory University Hospital Midtown-Radiology	Atlanta	Georgia
United States	Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates	Beverly	Massachusetts
United States	Minooka Healthcare Center - Ridge Road Campus	Channahon	Illinois
United States	Beth Israel Deaconess HealthCare-Chelsea	Chelsea	Massachusetts
United States	Oak Street Health Hermosa	Chicago	Illinois
United States	Oak Street Health Madison St.	Chicago	Illinois
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	Oak Street Health Pleasant Grove Primary Care Clinic	Dallas	Texas
United States	Emory at Dunwoody - Family Medicine	Dunwoody	Georgia
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	Gardner Healthcare Center of Morris Hospital	Gardner	Illinois
United States	Oak Street Health Gary Primary Care Clinic	Gary	Indiana
United States	Minooka Healthcare Center of Morris Hospital - Mondamin St.	Minooka	Illinois
United States	UW Health Yahara Clinic	Monona	Wisconsin
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	OneWorld Community Health Centers Livestock Exchange	Omaha	Nebraska
United States	OneWorld Community Health Centers Northwest	Omaha	Nebraska
United States	Berkshire Hillcrest Family Health Center	Pittsfield	Massachusetts
United States	Kootenai Clinic Family Medicine Post Falls	Post Falls	Idaho
United States	Northshore Medical Group Stevenson	Stevenson	Washington
United States	Emory at Rockbridge - Primary Care & Nephrology	Stone Mountain	Georgia
United States	Peace Health Fisher's Landing	Vancouver	Washington
United States	PeaceHealth Family Medicine of Southwest Washington	Vancouver	Washington
United States	Unity Health Care Anacostia Health Center	Washington	District of Columbia
United States	Unity Health Care Minnesota Avenue Health Center	Washington	District of Columbia
United States	Northshore Medical Group White Salmon	White Salmon	Washington
United States	Berkshire Williamstown Medical	Williamstown	Massachusetts
United States	UW Health Deforest-Windsor Clinic	Windsor	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Kaiser Permanente, National Institute of Mental Health (NIMH), University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Access to Addiction Care for Opioid Use Disorder	Change in Perceived access to care will be measured from self report using the Assessment of Perceived Access to Care (APAC) instrument (range 1-5, higher scores are better)	6 months
Other	Risk factors for premature mortality	Risk factors will include self-reported intent on self-harm, self-reported overdose, self-reported discontinuation of medications for opioid use disorder and the following adverse events reports: overdose, suicide attempt, hospitalization and ER admission.	6 months
Primary	Illicit Opioid Use	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."	6 months
Primary	Change in Mental Health Functioning	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)	6 Months
Secondary	Change in Depression Symptoms	Change in Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse)	6 months
Secondary	Change in Anxiety Symptoms	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)	6 months
Secondary	Change in PTSD Symptoms	Change in PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse)	6 months
Secondary	Medications for Opioid Use Disorder (MOUD) Persistence	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).	6 months