The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University

About this trial

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:

* Does the addition of a counseling and peer referral interventions in addition to usual primary care with low-threshold buprenorphine increase retention on medications for opioid use disorder? * Does the addition of counseling and peer referral intervention in addition to usual primary care with low-threshold buprenorphine increase engagement in primary care?

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:

* Meet with prescribers who will determine dose of buprenorphine and assess other medical issues as per treatment as usual with visits every 2-4 weeks * Meet with the integrated addictions counselor to develop rapport and support around clinic engagement, brief counseling intervention, and coordination of care in support of their MOUD * Be referred to a community based peer who meets with participants outside the clinic for support and advocacy for patient directed recovery goals * Meet with the research coordinator at 2, 3, and 6 months to complete follow-up surveys about their care and experiences

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Present to primary care at Central City Concern (CCC) within 8 weeks of starting or re-starting a treatment episode (defined as starting MOUD after not having received prescribed MOUD in an outpatient setting for OUD in the prior 30 days).

Who present to primary care at CCC and are not seeking treatment with MOUD and have not engaged in counseling services (e.g. harm reduction counseling) in the prior 30 days

Disqualifiers

Patient participants who present for addiction treatment but are ineligible to receive on-going services at Central City (i.e. they have existing primary care at another location, or are currently receiving opioid use disorder treatment at another clinic, such as methadone clinic) may not participate in the study.

Patient participants who are not able to verbally consent may not participate in the study.

Patients who do not have addiction to opioids may not participate in the study.

Patients who participated in Aim 2 would not be eligible for Aim 3

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: MOUD Plus Arm (treatment as usual + integrated counseling and peer referral)Experimental treatment 1 intervention
Group B: Treatment as usual Arm (low threshold MOUD prescribing in primary care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
assessed at 2 month, 3 months, and 6 month post enrollment

Secondary outcomes

1

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

Time frame
Assessed at 3-month follow-up post enrollment
2

Change in recovery capital instrument (BARC-10)

We assess recovery capital using the brief assessment of recovery capital (BARC-10) which ranges from minimum of 10 to maximum of 60.

Time frame
Change between baseline and assessed at 2-month, 3-month, and 6-month follow up
3

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.

Time frame
Change between baseline and assessed at 2-month, 3-month, and 6-month follow up

Other outcomes

1

Change in opioid use based on self-report

Modified Timeline Followback survey questions assess use of opioids since last time period

Time frame
Baseline, 2, 3, and 6 months
2

Change in other drug use (alcohol, methamphetamine) based on self-report

Modified Timeline Followback survey questions assess use of other drug use since last time period

Time frame
Baseline, 2, 3, and 6 months
3

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.

Time frame
Baseline, 2, 3, and 6 months

Sponsors and contacts

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Oregon Health and Science University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Central City Concern

Collaborator