Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384781
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-22
Brief 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
Sponsor:
Prisma Health-Upstate
Organization:
Prisma Health-Upstate
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 100000 lives were lost due to drug overdose in the past year of which 80 involved opioidsThe 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 StatesWith 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 factorsinterventions 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R61DA059892-01 | NIH | None | httpsreporternihgovquickSearchR61DA059892-01 |