Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Location status: Recruiting
NCT Number: NCT06527820
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Springfield, Massachusetts, 01199, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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.
Time frame: At 18 months
Clinician report of number of times they utilized the Talk About It Tool in preceding 12 months
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
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)
Time frame: At 6-18 months
Number of times patient reports using Talk About It on follow-up survey
Time frame: From 0-24 months
Time frame: From 0-12 months
Average number of eligible clinicians who complete training and survey instruments
Time frame: From 0-24 months
Average number of eligible patients who are enrolled each month
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
Time frame: From 0-24 months
Patients will complete a post-ED knowledge test developed by Steering Committee
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)
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)
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
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
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)
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)
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
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)
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
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
Time frame: From 0-24 months
Patients will report their 14- and 30- day use of illegal opioids
Contact information is provided by the study sponsor or research team.
Baystate Medical Center
Other
Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation (TALK ABOUT It)
Acronym: TalkAboutIt
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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