Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine
CTN-0156: Pilot Development and Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine
1 other identifier
interventional
20
1 country
1
Brief Summary
This study aims to develop and pilot test a patient decision aid (PtDA) for emergency department (ED)-initiated buprenorphine treatment for opioid use disorder (OUD). The PtDA will be evaluated for acceptability, impact on patient knowledge, decisional conflict, and buprenorphine uptake compared to treatment as usual (TAU).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedStudy Start
First participant enrolled
May 19, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
Study Completion
Last participant's last visit for all outcomes
December 31, 2026
March 11, 2026
March 1, 2026
5 months
December 3, 2025
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptability of Intervention Measure (AIM)
Day 1
Secondary Outcomes (4)
Knowledge about MOUD
pre and post intervention on day 1, and at 7 days
Treatment selection
Day 1
Decisional Conflict Scale
Day 1
Receipt of buprenorphine
Day 1, 7
Study Arms (2)
Patient Decision Aid
EXPERIMENTALThis arm will receive the patient decision aid
Treatment as Usual
NO INTERVENTIONThis will be treatment as usual without the patient decision aid
Interventions
This will include information structured for patients about buprenorphine as a treatment options in the emergency department.
Eligibility Criteria
You may qualify if:
- Age ≥18
- DSM-5 criteria for moderate-to-severe OUD
- Speaks and reads English
- Not currently prescribed MOUD
- Post-ED discharge patients with access to video/email
You may not qualify if:
- \- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lindsey Jennings, MD, MPH
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor-Faculty
Study Record Dates
First Submitted
December 3, 2025
First Posted
December 12, 2025
Study Start (Estimated)
May 19, 2026
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
De-identified data will be shared via the NIDA data repository in accordance with NIH Data Management and Sharing Policy.