Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation

NCT ID: NCT06527820

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-08-30

Brief Summary

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The increasing morbidity and mortality of the opioid epidemic has necessitated a reevaluation of current addiction treatment paradigms: medications for opioid use disorder, such as buprenorphine and methadone, are effective in decreasing one's risk of death and disability from opioid use, but are underutilized and often difficult to access. The 5000 Emergency Departments (EDs) in the US are potential additional locales for medication initiation, but currently only a small minority of ED patients with opioid use disorder are started on medications. This study will refine and pilot an intervention called Talk About It which aims to foster patient-centered care, 'meet patients where they are' for addiction treatment, and increase treatment initiation and adherence via facilitating Shared Decision-Making in the ED around these potentially life-saving options.

Detailed Description

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Participants (ED patients with untreated opioid use disorder) will be enrolled and followed prospectively before and after an ED-wide intervention training clinicians to use "Talk About It," a paper-based conversation aid designed to foster shared decision-making about the decision to start methadone and buprenorphine.

Outcomes will include the initiation of medications, treatment adherence, and patient-reported outcomes.

Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before and after trial. ED patients will be enrolled and followed before and after the intervention is delivered to clinicians. Clinicians at one site will receive the intervention and clinicians at control sites will complete outcome collection without receiving the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will receive usual care in all encounters.

Interventions

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Talk About It (conversation aid)

"Talk About It" is a conversation aid aimed to increase awareness of options and prompt discussion.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients aged 16 and older
* presenting with indications for Medications for Opioid Use Disorder (MOUD) initiation (opioid overdose, opioid withdrawal, complications of injection opioid use, untreated OUD)
* not currently on buprenorphine or methadone (in the past 7 days).

(Buprenorphine is FDA approved for patients aged 16 and older, so 16- and 17-year-olds may be included with parental consent.)

Exclusion Criteria

* No Opioid Use Disorder (OUD)
* already on MOUD
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baystate Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Schoenfeld, MD

Vice Chair of Research, Department of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baystate Medical Center

Springfield, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth Schoenfeld, MD, MS

Role: CONTACT

4137940000

Facility Contacts

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Jillian Tozloski

Role: primary

Other Identifiers

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BH-24-001

Identifier Type: -

Identifier Source: org_study_id

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