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NCT Number: NCT06527820

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location status: Recruiting

Location contact

Jillian Tozloski

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talk About It (conversation aid)

Behavioral

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

Primary outcomes

  1. Uptake of Talk About It (1)

    Time frame: At 18 months

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

  2. Uptake of Talk About It (2)

    Time frame: At 6-18 months

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

  3. Uptake of Talk About It (3)

    Time frame: At 6-18 months

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

  4. Uptake of Talk About It (4)

    Time frame: At 6-18 months

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

  5. Medications for Opioid Use Disorder (MOUD) initiation

    Time frame: From 0-24 months

    • Rate of Methadone or buprenorphine started in ED (via EHR)
    • Rate of Prescription written for buprenorphine
  6. Recruitment: Clinician enrollment

    Time frame: From 0-12 months

    Average number of eligible clinicians who complete training and survey instruments

  7. Recruitment: Patient enrollment

    Time frame: From 0-24 months

    Average number of eligible patients who are enrolled each month

  8. Acceptability/Feasibility of Talk About It

    Time frame: At 6 and 18 months

    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

Secondary outcomes

  1. Knowledge/Awareness

    Time frame: From 0-24 months

    Patients will complete a post-ED knowledge test developed by Steering Committee

  2. Perception of clinicians' compassion

    Time frame: From 0-24 months

    Patients will complete the Sinclair Compassion Questionnaire (SCQ) which assessed their perception of their clinician's compassion (5 questions, range 1-5, higher = better)

  3. Perceived Stigma

    Time frame: From 0-24 months

    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)

  4. Attitudes towards methadone

    Time frame: From 0-24 months

    Patients will complete the Attitudes About Methadone (OAM-5) to assess whether the intervention has changed negative attitudes about methadone

  5. Attitudes towards buprenorphine

    Time frame: From 0-24 months

    Patients will complete the Attitudes About Buprenorphine (modified OAM-5) to assess whether the intervention has changed negative attitudes about buprenorphine

  6. Engagement/SDM

    Time frame: From 0-24 months

    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)

  7. Trust

    Time frame: From 0-24 months

    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)

  8. Readiness to change

    Time frame: From 0-24 months

    Patients will fill out the Contemplation ladder scale (1-7), a validated tool to assess readiness for drug abstinence

  9. Stigma

    Time frame: From 0-24 months

    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)

  10. Self-efficacy for conversations about MOUD

    Time frame: From 0-24 months

    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

  11. Adherence to MOUD

    Time frame: From 0-24 months

    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

  12. Illegal opioid use

    Time frame: From 0-24 months

    Patients will report their 14- and 30- day use of illegal opioids

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Schoenfeld, MD, MS

CONTACT

[email protected]

4137940000

Sponsors and collaborators

Lead sponsor

Baystate Medical Center

Other

Registry information

Official study title

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

Acronym: TalkAboutIt

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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