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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07485335
Acronym
B-CARE
Enrollment
160
Registered
2026-03-20
Start date
2026-09-07
Completion date
2030-09-30
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Overdose, Opioid Use Disorder

Keywords

Emergency department, post discharge, buprenorphine, peer support specialist, telehealth

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 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.

Interventions

OTHERBundled intervention (Experimental)

a bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs.

OTHERcontrol 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

DRUGBuprenorphine (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.

BEHAVIORALScheduled 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.

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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

RCT

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. discharged from the ED and inpatient settings at the UAB hospital 2. 19 years or older (the age of majority in Alabama); 3. diagnosis of OUD and experiencing opioid overdose in the last 12 months; 4. prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge; 5. English speaking; 6. not actively psychotic and suicidal, or cognitively impaired. 7. Patients who are admitted to the hospital from the ED will be eligible for enrollment.

Exclusion criteria

1. living in a restricted environment (e.g., prison or jail facility, etc.); 2. currently enrolled in other clinical studies; 3. anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months; 4. known allergic reaction to buprenorphine; 5. critically ill or injured; 6. females with pregnancy (they are anticipated to request a higher level of care). 7. living outside of Alabama

Design outcomes

Primary

MeasureTime frameDescription
participant retention rate1 month and 3 months post hospital dischargemeasure the total number of participants who complete 1- month and 3-month treatment in the study
buprenorphine adherence rate1 month and 3 months post ED dischargechecking prescription rate and patients' self report of their taking medication
linkage rate to addiction treatment programs1 month and 3 months post hospital dischargepatients' self report and reports from addiction treatment programs
Frequency of Repeat Opioid OverdoseMonitored quarterly throughout the R33 study period beyond the 3-month interventionRepeat opioid overdose events monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
Healthcare Utilization (Hospital Revisit Rates)Monitored quarterly throughout the R33 study period beyond the 3-month interventionOpioid overdose-related hospital revisits after the initial ED encounter, monitored via EMR documentation at UAB Hospital
Adherence to Peer Support Specialist ContactThroughout the 12-week intervention period post hospital dischargeRate of participant adherence to the scheduled peer support specialist contact protocol, including daily contact in Week 1, every other day contact in Week 2, and weekly contact in Weeks 3-12 post-ED discharge, as recorded in peer activity logs documenting dates, times, and length of each telehealth contact
Opioid Overdose DeathMonitored quarterly throughout the R33 study period beyond the 3-month interventionOpioid overdose deaths monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital

Secondary

MeasureTime frameDescription
Childhood Trauma Questionnaire (CTQ)[Time Frame: Baseline, 1-month, and 3-month post hospital discharge]Participant quality of life will be assessed using validated self-reported survey min: 25, max: 125 (higher=worse)
Overdose Risk Scale (ORISK)[Time Frame: Baseline, 1-month and 3-month post hospital discharge]Participant quality of life will be assessed using validated self-reported surveys. min: 0, max: 24 (higher=worse)
Patient Satisfaction Scale (PSS)[Time Frame: Baseline, 1-month and 3-month post hospital discharge]Participant quality of life will be assessed using validated self-reported surveys. min: 0, max: 64 (higher=better)
Credibility and Expectancy Questionnaire (CEQ)[Time Frame: 1-month and 3-month post hospital discharge]Participant quality of life will be assessed using validated self-reported surveys. min: 6, max: 27 (higher=better)
Barratt Impulsiveness Scale (BIS)[Time Frame: Baseline, 1-month, and 3-month post hospital discharge]Participant mental health status will be assessed using validated self-report surveys. min: 24, max: 96 (higher=worse)
Generalized Anxiety Disorder 7 (GAD-7)[Time Frame: Baseline, 1-month, and 3-month post hospital discharge]Participant mental health status will be assessed using validated self-reported surveys. min: 0, max: 21 (higher=worse)
Patient Health Questionnaire 9 (PHQ-9)[Time Frame: Baseline, 1-month, and 3-month post hospital discharge]Participant mental health status will be assessed using validated self-reported surveys. min: 0, max: 27 (higher=worse)
Opioid Craving Scale (Craving)[Time Frame: Baseline, 1-month, and 3-month post hospital discharge]Participant mental health status will be assessed using validated self-reported surveys. min: 0, max: 30 (higher=worse)
Pittsburgh Sleep Quality Index (PSQI)[Time Frame: Baseline, 1-month, and 3-month post hospital discharge]Participant mental health status will be assessed using validated self-reported survey. min: 0, max: 21 (higher=worse)

Countries

United States

Contacts

CONTACTLi Li, MD;PhD
liyli@uabmc.edu2059346269
PRINCIPAL_INVESTIGATORLi Li, MD;PhD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026