Evaluation of a Patient Decision Aid for Emergency Depart... | NCT07278518

Studies
Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine

NCT07278518

Sponsor

Medical University of South Carolina

Status

Recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Opioid Use Disorder

Interventions

Patient Decision Aid for Opioid Use Disorder

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 19, 2026Estimated

Primary Completion Date

Oct 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 3, 2025

First Submission Date that Met QC Criteria

Dec 3, 2025

First Posted Date

Dec 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lindsey Jennings, Associate Professor-Faculty, Medical University of South CarolinaPrincipal Investigator

Lead Sponsor

Medical University of South CarolinaOTHER

Collaborators

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient Decision Aid	Experimental	This arm will receive the patient decision aid	Behavioral: Patient Decision Aid for Opioid Use Disorder
Treatment as Usual	No Intervention	This will be treatment as usual without the patient decision aid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient Decision Aid for Opioid Use Disorder	Behavioral	This will include information structured for patients about buprenorphine as a treatment options in the emergency department.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acceptability of Intervention Measure (AIM)		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Knowledge about MOUD	This is a multiple choice knowledge quiz	pre and post intervention on day 1, and at 7 days
Treatment selection		Day 1

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lindsey Jennings, MD, MPH	Contact	(843) 876-8023		jennil@musc.edu

Overall Officials

Name	Affiliation	Role
Lindsey Jennings, MD, MPH	Medical University of South Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina	Recruiting	Charleston	South Carolina	29425	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified data will be shared via the NIDA data repository in accordance with NIH Data Management and Sharing Policy.

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders
D004630	Emergencies

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided