An interventional study of Talk About It (conversation aid) in Opioid Use Disorder, sponsored by Baystate Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Baystate Medical Center · Not applicable, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 75 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Baystate Medical Center is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(Buprenorphine is FDA approved for patients aged 16 and older, so 16- and 17-year-olds may be included with parental consent.)
Exclusion Criteria:
"Talk About It" is a conversation aid aimed to increase awareness of options and prompt discussion.
Uptake of Talk About It (1)
Clinician report of number of times they utilized the Talk About It Tool in preceding 12 months
Time frame: 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
Time frame: 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)
Time frame: At 6-18 months
Uptake of Talk About It (4)
Number of times patient reports using Talk About It on follow-up survey
Time frame: 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
Time frame: From 0-24 months
Recruitment: Clinician enrollment
Average number of eligible clinicians who complete training and survey instruments
Time frame: From 0-12 months
Recruitment: Patient enrollment
Average number of eligible patients who are enrolled each month
Time frame: 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
Time frame: At 6 and 18 months
Knowledge/Awareness
Patients will complete a post-ED knowledge test developed by Steering Committee
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From 0-24 months
Illegal opioid use
Patients will report their 14- and 30- day use of illegal opioids
Time frame: From 0-24 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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