A Bundled Intervention to End Opioid Overdoses
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
discharged from the ED and inpatient settings at the UAB hospital
19 years or older (the age of majority in Alabama);
diagnosis of OUD and experiencing opioid overdose in the last 12 months;
prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;
Disqualifiers
living in a restricted environment (e.g., prison or jail facility, etc.);
currently enrolled in other clinical studies;
anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months;
known allergic reaction to buprenorphine;
Trial design
Design model
Parallel
Treatments tested in this trial
Bundled intervention (Experimental)
Other interventiona bundled intervention, including peer support, buprenorphine , telehealth, and linkage to community-based addiction programs.
control group
Other interventionparticipants 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
Buprenorphine (Experimental)
DrugParticipants 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.
Scheduled Peer Support Specialist (Experimental)
BehavioralParticipants 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.
Telemedicine Buprenorphine Treatment
Other interventionParticipants 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Experimental (Bundled Intervention)Experimental treatment 4 interventions
Group B: Control (Usual Care)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
participant retention rate
measure the total number of participants who complete 1- month and 3-month treatment in the study
Time frame
1 month and 3 months post hospital discharge2
buprenorphine adherence rate
checking prescription rate and patients' self report of their taking medication
Time frame
1 month and 3 months post ED discharge3
linkage rate to addiction treatment programs
patients' self report and reports from addiction treatment programs
Time frame
1 month and 3 months post hospital discharge4
Frequency of Repeat Opioid Overdose
Repeat opioid overdose events monitored through participant, family, and friend reports, and EMR documentation at UAB Hospital
Time frame
Monitored quarterly throughout the R33 study period beyond the 3-month interventionSecondary outcomes
1
Childhood Trauma Questionnaire (CTQ)
Participant quality of life will be assessed using validated self-reported survey min: 25, max: 125 (higher=worse)
Time frame
[Time Frame: Baseline, 1-month, and 3-month post hospital discharge]2
Overdose Risk Scale (ORISK)
Participant quality of life will be assessed using validated self-reported surveys. min: 0, max: 24 (higher=worse)
Time frame
[Time Frame: Baseline, 1-month and 3-month post hospital discharge]3
Patient Satisfaction Scale (PSS)
Participant quality of life will be assessed using validated self-reported surveys. min: 0, max: 64 (higher=better)
Time frame
[Time Frame: Baseline, 1-month and 3-month post hospital discharge]4
Credibility and Expectancy Questionnaire (CEQ)
Participant quality of life will be assessed using validated self-reported surveys. min: 6, max: 27 (higher=better)
Time frame
[Time Frame: 1-month and 3-month post hospital discharge]Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov