- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600414
Collaborating to Heal Addiction and Mental Health in Primary Care (CHAMP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This multi-site study involves a sequence of trials (Pre-Post -> Effectiveness -> Implementation 3) to examine our primary, secondary and exploratory objectives.
- 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.
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).
- 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20019
- Unity Health Care Minnesota Avenue Health Center
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Washington, District of Columbia, United States, 20020
- Unity Health Care Anacostia Health Center
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown-Radiology
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Atlanta, Georgia, United States, 30342
- Emory Clinic at Saint Joseph's - Primary Care
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Dunwoody, Georgia, United States, 30338
- Emory at Dunwoody - Family Medicine
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Stone Mountain, Georgia, United States, 30087
- Emory at Rockbridge - Primary Care & Nephrology
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Idaho
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Coeur d'Alene, Idaho, United States, 83814
- Kootenai Clinic Family Medicine Ironwood
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Coeur d'Alene, Idaho, United States, 83814
- Kootenai Clinic Family Medicine Residency
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Coeur d'Alene, Idaho, United States, 83814
- Kootenai Clinic Internal Medicine Coeur d'Alene
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Post Falls, Idaho, United States, 83854
- Kootenai Clinic Family Medicine Post Falls
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Illinois
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Channahon, Illinois, United States, 60410
- Minooka Healthcare Center - Ridge Road Campus
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Chicago, Illinois, United States, 60624
- Oak Street Health Madison St.
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Chicago, Illinois, United States, 60639
- Oak Street Health Hermosa
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Gardner, Illinois, United States, 60424
- Gardner Healthcare Center of Morris Hospital
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Minooka, Illinois, United States, 60447
- Minooka Healthcare Center of Morris Hospital - Mondamin St.
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Morris, Illinois, United States, 60450
- Morris Healthcare Center of Morris Hospital - Dresden Drive
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Oak Park, Illinois, United States, 60302
- Oak Street Health Chicago Ave Primary Care Clinic
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Indiana
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Gary, Indiana, United States, 46408
- Oak Street Health Gary Primary Care Clinic
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Massachusetts
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Beverly, Massachusetts, United States, 01915
- Beth Israel Lahey Health Primary Care & Specialty Care, Beverly Medical Associates
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Chelsea, Massachusetts, United States, 02150
- Beth Israel Deaconess HealthCare-Chelsea
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Pittsfield, Massachusetts, United States, 01201
- Berkshire Hillcrest Family Health Center
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Williamstown, Massachusetts, United States, 01267
- Berkshire Williamstown Medical
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Nebraska
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Omaha, Nebraska, United States, 68107
- OneWorld Community Health Centers Livestock Exchange
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Omaha, Nebraska, United States, 68134
- OneWorld Community Health Centers Northwest
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Texas
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Dallas, Texas, United States, 75217
- Oak Street Health Pleasant Grove Primary Care Clinic
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Fort Worth, Texas, United States, 76103
- Oak Street Health Meadowbrook Primary Care Clinic
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Fort Worth, Texas, United States, 76164
- Oak Street Health North Side Primary Care
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Washington
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Stevenson, Washington, United States, 98648
- Northshore Medical Group Stevenson
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Vancouver, Washington, United States, 98663
- PeaceHealth Family Medicine of Southwest Washington
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Vancouver, Washington, United States, 98683
- Peace Health Fisher's Landing
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White Salmon, Washington, United States, 98672
- Northshore Medical Group White Salmon
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Wisconsin
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Monona, Wisconsin, United States, 53716
- UW Health Yahara Clinic
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Windsor, Wisconsin, United States, 53598
- UW Health Deforest-Windsor Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Screen positive on the NIDA-ASSIST OUD items or referred to the trial by one of the clinic's providers AND
- Meet clinical criteria for ≥2 symptoms of OUD on the DSM-5 checklist (administered by a clinician) AND
- 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:
- Patient is being prescribed psychotropic medication (including MOUD) by a Mental Health Care Specialist (typically practicing in a specialty addiction treatment setting).
- Patient is receiving or prefers to seek OUD treatment in specialty care setting including opioid treatment programs
- Patient does not speak English or Spanish
- Patient is younger than 18 years of age
- Patient has a diagnosis of dementia
- Patient lacks the capacity to provide informed consent
- Patient doesn't plan on getting care at the clinic for the next 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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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.
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Experimental: 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.
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illicit Opioid Use
Time Frame: 6 months
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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."
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6 months
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Change in Mental Health Functioning
Time Frame: 6 Months
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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)
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6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Symptoms
Time Frame: 6 months
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Change in Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse)
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6 months
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Change in Anxiety Symptoms
Time Frame: 6 months
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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)
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6 months
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Change in PTSD Symptoms
Time Frame: 6 months
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Change in PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse)
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6 months
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Medications for Opioid Use Disorder (MOUD) Persistence
Time Frame: 6 months
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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).
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Access to Addiction Care for Opioid Use Disorder
Time Frame: 6 months
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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)
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6 months
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Risk factors for premature mortality
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Fortney, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SITE00000376
- UF1MH121942 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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