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

NCT06527820 | Recruiting

• 1 other identifier: BH-24-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

shared decision-making; decision aid; conversation aid; patient-centered care; addiction; emergency medicine

Outcome Measures

Primary Outcomes (8)

• Uptake of Talk About It (1)

  Clinician report of number of times they utilized the Talk About It Tool in preceding 12 months

  At 18 months

• Uptake of Talk About It (2)

  Number of paper versions of Talk About It tool shared with patients each month as monitored by research staff

  At 6-18 months

• Uptake of Talk About It (3)

  Number of times the digital version of Talk About It is accessed for clinical care each month (webpage use monitoring software)

  At 6-18 months

• Uptake of Talk About It (4)

  Number of times patient reports using Talk About It on follow-up survey

  At 6-18 months

• Medications for Opioid Use Disorder (MOUD) initiation

  1. Rate of Methadone or buprenorphine started in ED (via EHR) 2. Rate of Prescription written for buprenorphine

  From 0-24 months

• Recruitment: Clinician enrollment

  Average number of eligible clinicians who complete training and survey instruments

  From 0-12 months

• Recruitment: Patient enrollment

  Average number of eligible patients who are enrolled each month

  From 0-24 months

• Acceptability/Feasibility of Talk About It

  The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM) scales are brief, validated scales that clinicians will answer regarding acceptability, appropriateness, and feasibility of the intervention. Trained clinicians will complete these scales twice (once immediately after training and once 12 months after training. Range 1-5 with higher meaning better

  At 6 and 18 months

Secondary Outcomes (12)

• Knowledge/Awareness

  From 0-24 months

• Perception of clinicians' compassion

  From 0-24 months

• Perceived Stigma

  From 0-24 months

• Attitudes towards methadone

  From 0-24 months

• Attitudes towards buprenorphine

  From 0-24 months

Interventions

Talk About It (conversation aid) BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• No Opioid Use Disorder (OUD)
• already on MOUD

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Central Study Contacts

Elizabeth Schoenfeld, MD, MS

CONTACT

4137940000; elizschoen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will receive usual care in all encounters.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Research, Department of Emergency Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (1)