NCT06527820 · Baystate Medical Center
Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation
(TalkAboutIt)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Talk About It (conversation aid)
"Talk About It" is a conversation aid aimed to increase awareness of options and prompt discussion.
Primary outcome measures
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
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
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)
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
Medications for Opioid Use Disorder (MOUD) initiation
Time frame: From 0-24 months
1. Rate of Methadone or buprenorphine started in ED (via EHR) 2. Rate of Prescription written for buprenorphine
Recruitment: Clinician enrollment
Time frame: From 0-12 months
Average number of eligible clinicians who complete training and survey instruments
Recruitment: Patient enrollment
Time frame: From 0-24 months
Average number of eligible patients who are enrolled each month
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Springfield, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2024 · Source of record for eligibility and locations