Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:34 PM
Study NCT ID:
NCT07485335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bundled Intervention - Phase 2
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Implementation and Effectiveness Testing of a Bundled Post-Hospital Intervention for Non-fatal Opioid Overdoses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
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:
B-CARE
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:
This study is supported by the HEAL Initiative (https://heal.nih.gov). Opioid overdose deaths have reached historically high records in the U.S. 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 MOUD 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, i.e., 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 R33 phase, participants will be enrolled and randomized to either the intervention group (N=80) or the usual care group (UC, N=80). Patients will be enrolled from the same ED and same eligibility criteria as in the R61 phase will be applied. Randomization will be computer-generated using permuted blocks and will be stratified by age, sex at birth, ethnicity, comorbid diseases, and recruitment site (inpatient unit or emergency department) to ensure balanced allocation across groups. This study is open-label; participants and study staff will not be blinded to treatment assignment. In the intervention group, peers and physicians will provide the same intervention to patients as in the R61 phase, including peer support specialists meeting participants prior to ED discharge, scheduled telehealth contact throughout the 12-week period, and physician-led buprenorphine prescribing and management via telehealth. At the conclusion of the 12-week intervention, participants will receive a warm handoff from the peer support specialist to facilitate linkage to long-term community-based addiction treatment and recovery resources. 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. Follow-up assessments will be completed at 1 and 3 months via survey links sent to participants' cell phones and/or emails through REDCap, with reminder messages sent twice daily for 5 days prior to each assessment. 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.
In the R33 phase, participants will be enrolled and randomized to either the intervention group (N=80) or the usual care group (UC, N=80). Patients will be enrolled from the same ED and same eligibility criteria as in the R61 phase will be applied. Randomization will be computer-generated using permuted blocks and will be stratified by age, sex at birth, ethnicity, comorbid diseases, and recruitment site (inpatient unit or emergency department) to ensure balanced allocation across groups. This study is open-label; participants and study staff will not be blinded to treatment assignment. In the intervention group, peers and physicians will provide the same intervention to patients as in the R61 phase, including peer support specialists meeting participants prior to ED discharge, scheduled telehealth contact throughout the 12-week period, and physician-led buprenorphine prescribing and management via telehealth. At the conclusion of the 12-week intervention, participants will receive a warm handoff from the peer support specialist to facilitate linkage to long-term community-based addiction treatment and recovery resources. 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. Follow-up assessments will be completed at 1 and 3 months via survey links sent to participants' cell phones and/or emails through REDCap, with reminder messages sent twice daily for 5 days prior to each assessment. 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:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NIH | OTHER_GRANT | NIDA | View |