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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DA053390 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Central City Concern | UNKNOWN |
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The goal of this pilot clinical trial is to learn if a community informed designed program of addiction counseling with coordinated community peer navigator for people with Opioid Use Disorder (OUD) and other medical conditions can improve engagement in primary care and retention on buprenorphine.
The main questions it aims to answer are:
Researchers will compare the MOUD "Plus" intervention compared to primary care treatment as usual low-threshold buprenorphine prescribing practice to see if MOUD "Plus" improves retention and engagement.
Participants will upon screening and enrollment:
This is a pilot randomized controlled trial (N=70) comparing the refined team-based collaborative care model ("MOUD Plus") to treatment as usual.
The hypothesis is that this team-based intervention, called "MOUD-Plus", consisting of prescribers along with integrated substance use counselor, and referral to community based peer recovery support, can improve care engagement and retention on MOUD by increasing engagement, building trust, and offering patient directed therapeutic and peer-enhanced support for their treatment on MOUD.
Main existing components of MOUD: ("Treatment as Usual")
"MOUD Plus": New Components to support OUD and medical complexity
Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOUD Plus Arm (treatment as usual + integrated counseling and peer referral) | Experimental | Treatment as usual (prescriber trained in low threshold MOUD prescribing practices) plus coordinated warm-handoffs with integrated counseling services and coordinated referral to community based peer services |
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| Treatment as usual Arm (low threshold MOUD prescribing in primary care) | Active Comparator | Current treatment as usual consists of scheduled appointments with prescribers who are trained in low-threshold MOUD prescribing practices and who are part of a patient centered medical home model of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer) | Behavioral | In addition to treatment as usual (clinic visits for primary care and MOUD), patients will meet with clinic based addictions counselor who provides 1) rapport building ; 2) brief counseling interventions (e.g. motivational interviewing, change talk/solutions based therapy, harm reduction counseling); 3) referral to community resources. Patients will also be referred to community based peer recovery services who are credentialed and trained to "meet the person where they are" in the community and provide advocacy and support for client directed goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention on MOUD | Retention is defined as a composite measure assessed at follow-up on whether they report being prescribed and taking MOUD, and how days since the last follow-up they have been on MOUD, confirmed by chart review. | assessed at 2 month, 3 months, and 6 month post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement with care team | Engagement with care team is defined by number of unique contacts (in person visits, telephone visits, telephone outreach, peer engagements) the participant has with each arm during the course of the study | Assessed at 3-month follow-up post enrollment |
| Change in recovery capital instrument (BARC-10) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in opioid use based on self-report | Modified Timeline Followback survey questions assess use of opioids since last time period | Baseline, 2, 3, and 6 months |
| Change in other drug use (alcohol, methamphetamine) based on self-report |
Inclusion Criteria:
Eligibility/Inclusion Criteria. For Aim 3, criteria we seek to recruit include:
Patient participants 18 years and older
Have an OUD-related diagnosis (e.g. Opioid Use Disorder in remission, Opioid Dependence, Opioid Abuse, Substance Use Disorder - opioids, etc.), or have used fentanyl or heroin over the past 30 days
Who meet at least one of the following criteria:
Medical complexity (e.g. self-reported or verified in patient's electronic health record)
Have access to phone and/or computer for follow-up activities
Desire to engage in counseling and/or peer services
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 503-346-3043 | cheslocm@ohsu.edu | |
| Principal Investigator | Contact | 503-494-2010 |
| Name | Affiliation | Role |
|---|---|---|
| Brian Chan, MD MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central City Concern | Recruiting | Portland | Oregon | 97239 | United States |
After completion of the study, analysis, and publication, a de-identified IPD that underlie results in a publication will be made available upon reasonable request.
Starting after publication of the main results, and for 5 years after.
Anyone who makes a reasonable request to the primary investigator via email with rationale and data analysis plan/question
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"MOUD Plus": New Components to support OUD and medical complexity
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Care providers may be masked to treatment assignment.
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| Treatment As Usual (primary care with low threshold MOUD prescribing) | Behavioral | Treatment as usual arm consists of primary care clinical appointments with prescribers who treat medical issues and are trained to diagnosis and treat OUD using low threshold prescribing approaches. |
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We assess recovery capital using the brief assessment of recovery capital (BARC-10) which ranges from minimum of 10 to maximum of 60. |
| Change between baseline and assessed at 2-month, 3-month, and 6-month follow up |
| Change in patient reported trust in care team | We assess trust in care team using a modified version Wake Forest Physician Trust scale which ranges from minimum of 10 to maximum of 50. | Change between baseline and assessed at 2-month, 3-month, and 6-month follow up |
Modified Timeline Followback survey questions assess use of other drug use since last time period
| Baseline, 2, 3, and 6 months |
| Hospitalization and ED visits for substance use related problem | Patient reported survey question confirmed with medical chart review of number of hospitalizations, ED visits, or withdrawal management visits during follow-up period. | Baseline, 2, 3, and 6 months |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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