Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593093
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
A Bundled Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Bundled Intervention to End Opioid Overdose by Increasing Treatment Uptake Post Emergency Department Discharge
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Opioid overdose deaths have reached historically high records in the United States and are particularly concentrated among patients after emergency department ED discharge Evidence-based treatment modules to reduce repeat opioid overdose and mortality are lacking in this patient population A bundled intervention is proposed including telehealth peer support specialist buprenorphine and linkage for definitive care that is designed to increase treatment uptake in this patient population post-ED discharge reduce repeat opioid overdoses and end overdose deaths
Detailed Description:
Opioid overdose deaths have reached historically high records in the US and are particularly concentrated among patients after emergency department ED discharge Medications for opioid use disorder MOUDs including buprenorphine are the most effective treatments for opioid use disorder OUD as they reduce opioid-related overdoses and deaths Despite this less than 30 patients with OUD are treated with MOUDs Furthermore adequate treatment with MOUD can be more difficult in certain patient population ie patients with nonfatal opioid overdoses after ED discharge This patient population also accounts for substantial health care utilization frequent ED visits and the largest at-risk group for repeat overdoses and even deaths Many barriers including patients stigma on MOUDs lack of appropriate monitoring and support difficulty in navigating community-based treatment programs and being connected with buprenorphine clinics for continuity of care have been identified as contributors to poor treatment uptake post-ED discharge These barriers present a pressing need to develop novel treatment modules Peer support models and telehealth have been successful in improving service provision and increasing treatment uptake in substance use disorders However it remains untested if a bundled intervention of telehealth peers buprenorphine and linkage to definitive addiction programs can increase treatment uptake in this particular population Thus the purpose of this proposal is to test this bundled intervention specifically focusing on patients with OUD and nonfatal opioid overdoses post-ED discharge In the R61 phase 30 patients with OUD and opioid overdoses in the past 12 months will be enrolled from the University of Alabama at Birmingham Hospital when they are discharged from the ED Following ED discharge peers will contact patients daily in Week 1 post-ED discharge twice in Week 2 and weekly thereafter for 12 weeks using telehealth Physicians will continue prescribing buprenorphine Peers will also motivate and assist participants to engage in community-based treatment programs for continuity of care after intervention is completed Primary outcomes will be the feasibility and acceptability of this bundled intervention In the R33 phase participants will be enrolled and randomized to either the intervention group N80 or the usual care group UC N80 Patients will be enrolled from the same ED and same eligibility criteria as in the R61 phase will be applied In the intervention group peers and physicians will provide the same intervention to patients as in the R61 phase Patients in the UC group will receive the usual care that has been established at the ED including ED-initiated buprenorphine and a list of community-based substance treatment programs and buprenorphine clinics at ED discharge However no further intervention will be provided in the UC group Primary outcomes will be increased treatment uptake and retention after ED discharge and reduced opioid overdoses and ED revisits compared to the UC group If successful this project will lay the groundwork for a multi-site trial to validate the treatment and to identify actual implementation and sustainability barriers and best practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None