A Bundled Intervention

Conditions

• Opioid Overdose
• Opioid Use Disorder

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• a bundled intervention — OTHER
  a bundled intervention, including peer support, buprenorphine (ranging from 4mg-24mg, oral, daily), telehealth, and community-based addiction programs.
• control group — OTHER
  participants will not be intervened with this bundled treatment, but continue the usual care that has been established at UAB ED.

Study Details

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.

Key Dates

Start date

Feb 13, 2025

Status verified

Feb 2026

Primary completion

Nov 30, 2030

Completion

Nov 30, 2030

Study Design

Enrollment

190 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: phase 1
  After completing screening questions and obtaining consent, eligible participants will complete their baseline procedures and measures. All participants will then start the experimental, i.e., bundled intervention, the first week after their ED discharge, including peer support service and buprenorphine treatment with addiction physicians using telehealth. Each participant will be in the study for 3 months. During the study period, participants will be sent survey links to their cell phones and/or emails to complete self-report questionnaires via the Research Electronic Data Capture (REDCap) at 1-month and 3-month for follow-up assessments. Peers will remind the participants to complete the survey.
• Experimental: phase 2- experimental
  Participants will be enrolled the same way as in phase 1. After their enrollment, participants will be randomized to either the experimental (bundled intervention) group or the control (usual care group). Bundled intervention will have the same components as in the phase 1, including peer support, buprenorphine treatment, and telehealth up to 3 months after ED/hospital discharge, and linkage to definitive addiction treatment programs. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month for follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.
• Placebo Comparator: phase 2- control
  Participants who are randomized to the control group will receive the usual care that has been established in the ED at UAB hospital. The current usual care at the UAB ED includes a thorough assessment, buprenorphine initiation as appropriate, peer referral, and a written list of buprenorphine clinics. Participants will also receive information about community-based substance use treatment programs. However, these services are at the participant's own discretion to navigate and attend after ED discharge. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month for follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.

Primary Outcome Measure

participant retention rate [ Time Frame: 1 month and 3 months post ED discharge ]

Central Contacts

• Li Li, MD;PhD
  2059346269
  [email protected]

Locations (1)

Find similar trials in Birmingham, AL

Related Studies

• A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
  PHASE4 · Recruiting · VA Office of Research and Development · Tuscaloosa, Alabama
• Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
  PHASE4 · Recruiting · Yale University · Birmingham, Alabama
• Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
  Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
• HIV, Equity, and Addiction Training (HEAT) Program
  Recruiting · University of Alabama at Birmingham · Birmingham, Alabama