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Recruiting NCT07278518

Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine

No phase Interventional Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Decision Aid for Opioid Use Disorder.
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CTN-0156: Pilot Development and Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine

Overview

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).

Interventions

  • Behavioral Patient Decision Aid for Opioid Use Disorder
    This will include information structured for patients about buprenorphine as a treatment options in the emergency department.

Primary outcome measures

  • Acceptability of Intervention Measure (AIM) [Time frame: Day 1]
Secondary outcome measures (4)
  • Knowledge about MOUD [Time frame: pre and post intervention on day 1, and at 7 days]
  • Treatment selection [Time frame: Day 1]
  • Decisional Conflict Scale [Time frame: Day 1]
  • Receipt of buprenorphine [Time frame: Day 1, 7]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

\- Prisoners

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT07278518 · Pro00145434

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗