Mental Health Disorder, Opioid-use Disorder
Conditions
Keywords
Primary Care, Collaborative Care
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
Interventions
OTHERCollaborative 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.
OTHERCollaborative 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.
Sponsors
National Institute of Mental Health (NIMH)
University of Arkansas
Kaiser Permanente
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes are assessed by patient survey, and survey administrators will be masked to randomizations status.
Intervention model description
Cluster Randomized Trial. Clinics within healthcare systems are paired and randomized to intervention or control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use Other Than As Prescribed | 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. |
| Mental Health Functioning | 6 Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms | 6 months | 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) |
| Medications for Opioid Use Disorder (MOUD) Persistence | 90 days prior to the 6-month follow-up | MOUD persistence will be measured from self report and specified as the proportion of days the study participant reported taking the MOUD medication during the 90 prior to the 6-month follow-up. |
| PTSD Symptoms | 6 months | PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse) |
| Depression Symptoms | 6 months | Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived Access to Addiction Care for Opioid Use Disorder | 6 months | 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) |
| Risk Factors for Premature Mortality | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 conditions.
Collaborative Care (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. | 132 |
| 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 mental health conditions and opioid use disorder.
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. | 100 |
| Total | 232 |
Baseline characteristics
| Characteristic | Collaborative Care for Mental Health Symptoms | Total | Collaborative Care for Opioid Use Disorder and Mental Health Symptoms |
|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 12.3 | 40.9 years STANDARD_DEVIATION 12.4 | 39.1 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 20 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants | 211 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Mental Health Functioning | 34.18 units on a scale STANDARD_DEVIATION 13.48 | 34.45 units on a scale STANDARD_DEVIATION 13.17 | 34.81 units on a scale STANDARD_DEVIATION 12.77 |
| Opioid Use Other Than As Prescribed | 5.73 Days STANDARD_DEVIATION 10.79 | 4.84 Days STANDARD_DEVIATION 9.7 | 3.66 Days STANDARD_DEVIATION 8.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 15 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 112 Participants | 193 Participants | 81 Participants |
| Region of Enrollment United States | 132 participants | 232 participants | 100 participants |
| Sex/Gender, Customized Man | 57 Participants | 92 Participants | 35 Participants |
| Sex/Gender, Customized Non-binary or gender fluid | 1 Participants | 1 Participants | 0 Participants |
| Sex/Gender, Customized Woman | 74 Participants | 139 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 132 | 0 / 100 |
| other Total, other adverse events | 1 / 132 | 3 / 100 |
| serious Total, serious adverse events | 16 / 132 | 14 / 100 |
Outcome results
Primary
Mental Health Functioning
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)
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Care for Mental Health Symptoms | Mental Health Functioning | 38.90 units on a scale | Standard Deviation 13.2 |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Mental Health Functioning | 39.09 units on a scale | Standard Deviation 14.03 |
p-value: 0.53295% CI: [-4.97, 2.57]Multi-level model to account for cluster
Primary
Opioid Use Other Than As Prescribed
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.
Time frame: 6 months
Population: Participants completing the 6-month follow-up survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Care for Mental Health Symptoms | Opioid Use Other Than As Prescribed | 3.92 Days | Standard Deviation 8.86 |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Opioid Use Other Than As Prescribed | 0.72 Days | Standard Deviation 3.61 |
p-value: <0.00195% CI: [0.03, 0.38]Multi-level model to account for cluster
Secondary
Anxiety Symptoms
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)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Care for Mental Health Symptoms | Anxiety Symptoms | 55.61 units on a scale | Standard Deviation 7.85 |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Anxiety Symptoms | 55.82 units on a scale | Standard Deviation 7.72 |
Secondary
Depression Symptoms
Depression symptoms will be measured from self report using the SCL-20 (range 0-4, higher scores are worse)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Care for Mental Health Symptoms | Depression Symptoms | 1.30 units on a scale | Standard Deviation 0.82 |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Depression Symptoms | 1.24 units on a scale | Standard Deviation 0.83 |
Secondary
Medications for Opioid Use Disorder (MOUD) Persistence
MOUD persistence will be measured from self report and specified as the proportion of days the study participant reported taking the MOUD medication during the 90 prior to the 6-month follow-up.
Time frame: 90 days prior to the 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Care for Mental Health Symptoms | Medications for Opioid Use Disorder (MOUD) Persistence | 0.74 proportion | Standard Deviation 0.42 |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Medications for Opioid Use Disorder (MOUD) Persistence | 0.90 proportion | Standard Deviation 0.29 |
Secondary
PTSD Symptoms
PTSD symptoms will be measured from self-report using the PCL-5 (range 0-80, higher scores are worse)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Care for Mental Health Symptoms | PTSD Symptoms | 28.29 units on a scale | Standard Deviation 19.01 |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | PTSD Symptoms | 27.32 units on a scale | Standard Deviation 18.21 |
Other Pre-specified
Perceived Access to Addiction Care for Opioid Use Disorder
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)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Care for Mental Health Symptoms | Perceived Access to Addiction Care for Opioid Use Disorder | 3.82 units on a scale | Standard Deviation 0.86 |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Perceived Access to Addiction Care for Opioid Use Disorder | 4.00 units on a scale | Standard Deviation 0.74 |
Other Pre-specified
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Care for Mental Health Symptoms | Risk Factors for Premature Mortality | 0.51 Count of risk factors for mortality | Standard Deviation 0.5 |
| Collaborative Care for Opioid Use Disorder and Mental Health Symptoms | Risk Factors for Premature Mortality | 0.34 Count of risk factors for mortality | Standard Deviation 0.47 |