Central City Concern
Portland, Oregon, 97239, United States
Location status: Recruiting
Location contact
Brian Chan, MD MPH
PRINCIPAL_INVESTIGATOR
Research Coordinator
CONTACT
NCT Number: NCT06837662
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
Location status: Recruiting
Brian Chan, MD MPH
PRINCIPAL_INVESTIGATOR
Research Coordinator
CONTACT
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: collaborative care, integrated behavioral health, MOUD Plus
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.
Other names: usual care, treatment as usual, low-threshold MOUD prescribing
Time frame: assessed at 2 month, 3 months, and 6 month post enrollment
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 3-month follow-up post enrollment
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: Change between baseline and assessed at 2-month, 3-month, and 6-month follow up
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
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: Baseline, 2, 3, and 6 months
Modified Timeline Followback survey questions assess use of opioids since last time period
Time frame: Baseline, 2, 3, and 6 months
Modified Timeline Followback survey questions assess use of other drug use since last time period
Time frame: Baseline, 2, 3, and 6 months
Patient reported survey question confirmed with medical chart review of number of hospitalizations, ED visits, or withdrawal management visits during follow-up period.
Contact information is provided by the study sponsor or research team.
Principal Investigator
CONTACT
Study Coordinator
CONTACT
Oregon Health and Science University
Other
Designing Intensive Primary Care Interventions to Improve Addiction Treatment for Medically and Socially Complex Patients: The "MOUD PLUS (MOUD+)" Study
Acronym: MOUD+
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05829655
Chemically-Induced Disorders, Mental Disorders
Baltimore, Maryland, United States
View Trial DetailsNCT06574009
Cancer Survivor, Chemically-Induced Disorders
Indianapolis, Indiana, United States
View Trial DetailsNCT03675386
Chemically-Induced Disorders, Chronic Pain
Toronto, Ontario, Canada
View Trial DetailsNCT06949826
Ankle Fracture Surgery, Ankle Fractures
St Louis, Missouri, United States
View Trial Details