Clinical trial NCT06384781: STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists
Official title: Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: peer support specialist
peer recovery coach
OUD
opioid use disorder
mobile health clinic
rural
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Clemson University
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-04-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a 1-arm prospective interventional cohort quasi-experimental with retrospective control group. Enrolled participants will be compared to previously established mobile health patients, who did not work with a peer recovery coach, for buprenorphine treatment and adherence outcomes. 90 patients will be recruited from the mobile health units in rural counties in Upstate South Carolina. Visits consist of a baseline and 3 month follow up.

The study will focus to develop, deliver, and evaluate an innovative 1) Peer Support Specialist (PSS) intervention to increase Medications for Opioid Use Disorder (MOUD) initiation and retention rates in rural populations and underserved communities, and 2) dynamic modeling framework to prioritize at-risk communities for delivery of Mobile Health Clinics. the interventions will be developed in the R61 phase and implemented in a pilot study to determine the effectiveness on initiation and retention. With opioid overdose deaths continuing to rise in South Carolina (SC) and nationally, our sustainable framework has potential to prevent hundreds to thousands of opioid overdoses in SC and can be scaled up in other regions to save many more lives.

Detailed description: Over 100,000 lives were lost due to drug overdose in the past year, of which 80% involved opioids.The majority of opioid-related deaths were due to fentanyl, an illicit opioid that has been labeled the single deadliest drug threat ever encountered in the United States.With opioid overdose deaths doubling in the past two years, there are no current signs that the epidemic is slowing down. Despite the effectiveness of medications for opioid use disorder (MOUD) at reducing opioid use, only 10% of those in need receive treatment. Furthermore, treatment retention is low (30-50%). Low treatment initiation and retention rates for Opioid Use Disorder (OUD) are especially concerning for rural and underserved communities, who rarely have access to clinicians prescribing MOUD and experience substantial barriers to care, including lack of insurance, social isolation, homelessness, transportation issues, and stigma. Given these populations are also at an elevated risk of overdose due to many of these same factors,interventions to increase MOUD initiation, retention, and overdose prevention in rural and underserved communities are urgently needed.

Our proposal aims to improve medication for opioid use disorder (MOUD) treatment rates and prevent overdose deaths in underserved communities using mobile health clinics (MHC). This will be achieved by developing, testing, delivering, and evaluating two key components: 1) a Peer Support Specialist (PSS) intervention to enhance MOUD initiation and retention, and 2) a modeling framework to identify high-risk communities for MHC delivery of opioid use disorder (OUD) interventions, based on the prevention of overdose deaths in those areas. Previous research has shown that such modeling tools can significantly enhance the efficiency of resource allocation across different health issues.

In the initial R61 phase, we will develop the PSS intervention and modeling framework.

The primary goal of aim 1 in the R61 phase is to assess the early fidelity, acceptability, and effectiveness of the PSS Service Delivery in boosting MOUD initiation and retention in rural and underserved populations. This intervention will draw from the successful assertive community engagement (ACE) model PSS interventions for substance use disorders and will be crafted based on qualitative interviews with PSS and OUD patients, as well as pilot data.

Eligibility criteria: Inclusion Criteria:

* Age 18+
* Have diagnosis of OUD
* New patient of the mobile clinic

Exclusion Criteria:

* Currently prescribed MOUD
* Currently working with a PSS
* Current suicidal ideation, as verified through the Patient Health Questionnaire-9 (PHQ-9)
* Having a severe medical or psychiatric disability that would hinder participation in the study, as determined by nurse practitioner
* Unable to read/speak English
* Unable to read and comprehend the consent materials and other study materials

Primary outcomes:
measure: Medication for Opioid Use Disorder (MOUD) Initiation
timeFrame: 3 months
measure: MOUD Retention
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clinton
country: United States
facility: Prisma Addiction Medicine Center - Mobile Health Clinic
state: South Carolina
city: Seneca
country: United States
facility: Prisma - Addiction Medicine Center Mobile Health Clinic
state: South Carolina
Study officials:
References: