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

Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation (TALK ABOUT It)

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Talk About It (conversation aid)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Schoenfeld, MD, MS; Phone Number: 4137940000; Email: elizschoen@gmail.com

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Recruiting
      • Baystate Medical Center
      • Contact: Jillian Tozloski; Email: jillian.tozloski@baystatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	Rate of Methadone or buprenorphine started in ED (via EHR); Rate of Prescription written for buprenorphine	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge/Awareness	Patients will complete a post-ED knowledge test developed by Steering Committee	From 0-24 months
Attitudes towards methadone	Patients will complete the Attitudes About Methadone (OAM-5) to assess whether the intervention has changed negative attitudes about methadone	From 0-24 months
Attitudes towards buprenorphine	Patients will complete the Attitudes About Buprenorphine (modified OAM-5) to assess whether the intervention has changed negative attitudes about buprenorphine	From 0-24 months
Readiness to change	Patients will fill out the Contemplation ladder scale (1-7), a validated tool to assess readiness for drug abstinence	From 0-24 months
Adherence to MOUD	Patients will report their 14- and 30- day use of MOUD, which will be confirmed in the EHR; 60 day adherence will be obtained from EHR and methadone clinics	From 0-24 months
Illegal opioid use	Patients will report their 14- and 30- day use of illegal opioids	From 0-24 months
Perception of clinicians' compassion	Patients will complete the Sinclair Compassion Questionnaire (SCQ) which assessed their perception of their clinician's compassion (5 questions, range 1-5, higher = better)	From 0-24 months
Perceived Stigma	Patients will complete a Modified Perceived Stigma of Addiction Scale (PSAS) which assess their perception of their clinician's stigma (Q1 binary, Q2-4, range 1-5 with higher = more stigma)	From 0-24 months
Engagement/SDM	Patients will complete the Shared Decision-Making Process Scale (SDM-P) to assess their perceived involvement in decision-making (4 questions, scored 0/1 with higher = more engagement)	From 0-24 months
Trust	Patients will complete the validated 5-item Trust in Physician Scale to assess their trust in the physician (5 questions, 1-5, with higher = more trust; 1 question reverse coded)	From 0-24 months
Stigma	Clinicians will complete the Opening Minds Stigma Scale for Health Care Providers (OMS-HC) twice to assess for changes in stigma (19 questions, each 1-5, lower scrore = less stigma)	From 0-24 months
Self-efficacy for conversations about MOUD	Clinicians will complete the Self-efficacy in clinical communication scale (SE-12) to assess for changes in self-efficacy around communication (12 questions, response options 1-10, higher score = more self efficacy	From 0-24 months

Collaborators and Investigators

• Sponsor: Baystate Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: addiction; patient-centered care; decision aid; emergency medicine; shared decision-making; conversation aid
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: BH-24-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No