This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention.
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention. In this project phase, the study will conduct an RCT to examine the effectiveness of the PSS on medications for OUD (MOUD) initiation and retention among these at-risk populations; and extend and optimize the modeling framework to improve effectiveness and utility of the MHC-directed PSS intervention, including cost-effectiveness. The primary outcomes are MOUD initiation and retention. The study aims to enroll 750 participants with moderate to severe OUD. Through a 1:1 ratio using a computer randomization algorithm, 375 participants will be enrolled in the MHC + PSS intervention condition, while 375 will receive the standard MHC protocol. The MHC + PSS intervention condition entails linkage, via potential participants' visiting of a MHC, of participants to PSS services. PSSs are individuals who have had a direct experience with and successful recovery from OUD. PSSs are trained to provide recovery support services according to the Assertive Community Engagement (ACE) model of recovery support. To consistently deliver the ACE model of recovery support, the PSSs use the PSS checklist, developed and validated by our team in the R61 phase. In the R33 phase (Aim 1), the MHC + PSS protocol will be delivered to communities identified by the modeling framework as optimal locations for MHC delivery. The control condition involves the standard MHC protocol. Through the opioid use surveillance metrics and modeling framework from R61 Aim 2, the MHC will be allocated to the communities that are determined to be at highest risk for OUD, opioid-related hospitalizations, and overdose. Participants in the standard of care condition will receive MHC services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provided with fentanyl test strips and take-home naloxone for overdose reversal, without the added PSS support. The R33 phase (Aim 2) will also develop a model to evaluate the population impact and cost-effectiveness of the PSS on preventing fatal overdose.
Participants are recruited from mobile health clinics (MHC) delivered to communities using a predictive modeling framework to target areas for optimal MHC allocation to maximize prevention of overdose deaths. Patients randomized to the intervention arm are linked to a peer support specialist. Peer support specialists are Certified Peer Support Specialists (CPSS) who have lived experience with Opioid Use Disorder (OUD) and OUD recovery. Peer support specialists offer consistent personalized recovery support and generalized social support based on a peer support checklist. Peer support specialists will maintain contact and provide support for the participant for 6 months post-baseline, following a peer support manual.
Prisma Health Upstate
Greenville, South Carolina, United States
RECRUITINGMedications for Opioid Use Disorder (MOUD) Initiation
MOUD initiation defined as receipt of first MOUD prescription within 3 months since baseline assessment.
Time frame: 3 months
Medications for Opioid Use Disorder (MOUD) Retention
MOUD retention at 6 months defined as receipt of 80% of MOUD prescriptions in first 6 months since baseline assessment.
Time frame: 6 months
Adherence to Buprenorphine
Medication Adherence Self-Report Inventory (MASRI)
Time frame: Weekly; 24 weeks
Barriers to Healthcare
Social Determinations of Health (SDOH)
Time frame: 90 days
Frequency of Opioid Use
Addiction Severity Index (ASI-Lite)
Time frame: Monthly
Overdose
Time frame: Weekly; 24 weeks
Hospitalizations/Emergency Department Visits
Time frame: Weekly; 24 weeks
Engagement in other Recovery Support Services
Time frame: Weekly; 24 weeks
Naloxone/Narcan Administration
Time frame: Weekly; 24 weeks
Fentanyl Test Strip Use
Time frame: Weekly; 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
Recovery Capital
Brief Assessment of Recovery Capital (BARC-10)
Time frame: 90 days
Social Support
Medical Outcome Study (MOS)
Time frame: 90 days
Depression symptoms
Patient Health Questionnaire (PHQ-9)
Time frame: 90 days
Anxiety symptoms
Generalized Anxiety Disorder (GAD-7)
Time frame: 90 days
Post-Traumatic Stress Disorder (PTSD) symptoms
PTSD Checklist (PCL-5)
Time frame: 90 days