NCT07485335

A Bundled Intervention to End Opioid Overdoses

Implementation and Effectiveness of A Bundled Intervention to End Opioid Overdoses by Increasing Treatment Uptake Post Discharge

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 Helping to End Addiction Long-term (HEAL) Initiative (https://heal.nih.gov). Opioid overdose deaths have reached historically high records in the United States. 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 usual care group will receive the standard 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 usual care group. Follow-up assessments will be completed at 1 and 3 months via survey links sent to participants' cell phones and/or emails through Research Electronic Data Capture (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 usual care 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.

Conditions

• Opioid Use Disorder
• Opioid Overdose

Interventions

Type	Name	Description
OTHER	Bundled intervention (Experimental)	a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs.
OTHER	control group	participants will not be intervened with this bundled treatment, but continue the usual care that has been established at University of Alabama at Birmingham (UAB) hospital
DRUG	Buprenorphine (Experimental)	Participants in the experimental arm will receive buprenorphine treatment for opioid use disorder, including buprenorphine/naloxone (sublingual film or tablet), buprenorphine (sublingual tablet), or buprenorphine extended-release, as determined by the study physician via telehealth. Medication will be provided for the duration of the 12-week intervention period. Participants without insurance or who are underinsured will be provided medication at no cost to ensure equitable access.
BEHAVIORAL	Scheduled Peer Support Specialist (Experimental)	Participants in the experimental arm will be introduced to a peer support specialist prior to hospital discharge. Peer support specialists, who have lived experience with substance use disorder and recovery, will provide ongoing support throughout the 12-week intervention period. Specialists will assist participants in navigating and attending community-based addiction treatment resources, including buprenorphine clinics and substance use treatment programs. 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.
OTHER	Telemedicine Buprenorphine Treatment	Participants in the experimental arm will receive telehealth-enabled services throughout the 12-week intervention period. Addiction physicians will conduct virtual visits to evaluate, prescribe, and manage buprenorphine for opioid use disorder. Peer support specialists will maintain scheduled contact with participants via telehealth to provide ongoing support and monitor participant progress. Follow-up assessments at 1 and 3 months will be completed remotely 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.

Timeline

• Start date: 2026-09-07
• Primary completion: 2030-09-30
• Completion: 2030-09-30
• First posted: 2026-03-20
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study