Collaborating to Heal Addiction and Mental Health in Primary Care (CHAMP)

• ClinicalTrials.gov Identifier: NCT04600414
• Recruitment Status: Not yet recruiting
• First Posted: October 23, 2020
• Last Update Posted: October 23, 2020
• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH); University of Arkansas; Kaiser Permanente
• Information provided by (Responsible Party): John Fortney, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid-use Disorder; Mental Health Disorder	Other: Collaborative Care for Mental Health Disorders; Other: Collaborative Care for Opioid Use Disorder	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Cluster Randomized Trial. Clinics within healthcare systems are paired and randomized to intervention or control.
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes are assessed by patient survey, and survey administrators will be masked to randomizations status.
• Primary Purpose: Treatment
• Official Title: Collaborating to Heal Addiction and Mental Health in Primary Care
• Estimated Study Start Date: November 2020
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: May 2024

Arms and Interventions

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.	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.
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.	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.; Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Illicit Opioid Use [ Time Frame: 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."
2. Change in Mental Health Functioning [ Time Frame: 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 :

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

Other Outcome Measures:

1. Change in Access to Addiction Care for Opioid Use Disorder [ Time Frame: 6 months ]
   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)
2. Risk factors for premature mortality [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (≥ 10) OR generalized anxiety on the GAD-7 (≥ 10) OR PTSD on the PC-PTSD-5 (≥ 3) 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.

Contacts and Locations

Contacts

Contact: John Fortney, PhD; 206.685.6955; fortneyj@uw.edu

Contact: Lori Ferro, MHA; 206.221.8523; ljf9@uw.edu

Sponsors and Collaborators

University of Washington

National Institute of Mental Health (NIMH)

University of Arkansas

Kaiser Permanente

Investigators

• Principal Investigator: John Fortney, PhD; University of Washington

More Information

• Responsible Party: John Fortney, Professor, School of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT04600414
• Other Study ID Numbers: SITE00000376; UF1MH121942 ( U.S. NIH Grant/Contract )
• First Posted: October 23, 2020
• Last Update Posted: October 23, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The PIs will follow the NIH Healthcare Systems Research Collaboratory recommendations for data sharing. Data from this project will be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data. Data will be shared via the National Database for Clinical Trials (NDCT) related to Mental Illness. Investigators will certify the quality of all data generated by grants funded under this FOA prior to submission to NDCT and review their data for accuracy after submission. Precautions will be made regarding patient confidentiality, including HIPAA-compliant patient de-identification for all patients. Public-use datasets will not include patient identifiers, or health system identifiers, characteristics or prescribing/referral practices of individual providers.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: The data will be made available in May of 2024.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Fortney, University of Washington:

Primary Care; Collaborative Care

Additional relevant MeSH terms:

Disease; Opioid-Related Disorders; Mental Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents