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

Opioid Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384781
• Other study ID #: 2130836
• Secondary ID: R61DA059892-01
• Status: Recruiting
• Start date: April 2024
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Prisma Health-Upstate
• Contact: Marisol A Miranda, BS
• Phone: 864-501-9693
• Email: marisol.miranda[@]prismahealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria specific for PSSs: currently working as a PSS for individuals with OUD; have worked as a PSS for at least 6 months; are in active recovery (2+ years)
• Inclusion criteria specific for patients with OUD: patients with OUD (active or in early recovery, a year or more). OUD will be identified through clinician determination or through the 11-item DSM-V - Checklist for OUD administered by a research coordinator or NP at either the mobile health clinic or addiction medicine center at GMH
• Inclusion criteria for all: at least 18 years of age

Exclusion Criteria:

• Exclusion criteria specific for PSSs: n/a
• Exclusion criteria specific for patients with OUD: experiencing active withdrawal through clinician determination
• Exclusion criteria for all: unable to provide informed consent, inability to speak proficient English

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Locations

Country	Name	City	State
United States	Prisma Addiction Medicine Center - Mobile Health Clinic	Clinton	South Carolina
United States	Prisma - Addiction Medicine Center Mobile Health Clinic	Seneca	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Clemson University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Conceptualization	qualitative responses to PSS roles/responsibilities for clients with OUD; yes/no responses to whether or not they engage in the activities listed in the PRC Checklist for all SUDs.	January 2024 - January 2025
Primary	Phase 2: Conceptulization	responses to services that individuals with OUD would be interested in receiving from a PSS and responses to desirability of MOUD. This info will be used to develop the initial PSS Checklist for OUD.	January 2024 - January 2025
Primary	Phase 3: Refinement	: qualitative responses to items on the PSS Checklist for OUD that the PSSs regularly engage in as well as activities that may be missing from this new checklist when working with clients with OUD. Responses for perceived helpfulness, usefulness, and satisfaction of the checklist for preliminary acceptability.	January 2024 - January 2025
Primary	Phase 4: Validation	Validation: quantitative self-report responses to assess the perceived helpfulness, ease of use, desirability of use, accuracy, and meaningfulness of the new checklist for PSS delivery to individuals with OUD.	January 2024 - January 2025
Primary	Phase 5: Preliminary efficacy	For PSS data, qualitative information on the acceptability of administering the new checklist will be obtained monthly. The PSSs will meet with Co-I Byrne each month and provide feedback on challenges they may be experiencing, including implementing the new checklist. At the end of the pilot period, PSSs will also be asked to rate the usefulness, ease of use, and overall satisfaction with the new checklist based on their experience during the pilot period. At the end of the 3-month PSS service delivery period, participants will be asked to indicate the perceived usefulness, helpfulness, and overall satisfaction of the PSS service, using a 1 - 5 Likert scale from Strongly Disagree to Strongly Agree.148 Through open-ended questions, participants will be asked to indicate aspects of the PSS service that they enjoyed and/or found beneficial.	January 2024 - January 2025

External Links

•   NIH RePORTER