Designing Intensive Primary Care Interventions to Improve Addiction Treatment for Medically and Socially Complex Patients: The "MOUD PLUS (MOUD+)" Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Retention on MOUD
研究概览
简要总结
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
详细描述
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")
- Scheduled or Walk in clinic M-F 8-5 pm
- Visits with buprenorphine waivered prescriber
- Prescribers are trained to initiate and continue treatment same day ("low threshold" prescribing)
- Connection to usual primary care services
- On-site lab, pharmacy, and screening for HIV, hep C with referral to treatment
"MOUD Plus": New Components to support OUD and medical complexity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Care providers may be masked to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Have been receiving MOUD in prior 30 days but had a return to use (used fentanyl or heroin) within the past 30 days
- •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
排除标准
- •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
- •Patients who lack stable phone access may not participate in the study.
研究组 & 干预措施
MOUD Plus Arm (treatment as usual + integrated counseling and peer referral)
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
干预措施: MOUD "Plus" Intervention (treatment as usual + coordinated counseling and referral to community based peer) (Behavioral)
Treatment as usual Arm (low threshold MOUD prescribing in primary care)
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
干预措施: Treatment As Usual (primary care with low threshold MOUD prescribing) (Behavioral)
结局指标
主要结局
Retention on MOUD
时间窗: 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.
次要结局
- Engagement with care team(Assessed at 3-month follow-up post enrollment)
- Change in recovery capital instrument (BARC-10)(Change between baseline and assessed at 2-month, 3-month, and 6-month follow up)
- Change in patient reported trust in care team(Change between baseline and assessed at 2-month, 3-month, and 6-month follow up)
研究者
Brian L Chan
Associate Professor
Oregon Health and Science University