Clinical trial NCT06527820: Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation
Official title: Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation (TALK ABOUT It)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: shared decision-making
decision aid
conversation aid
patient-centered care
addiction
emergency medicine
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before and after trial. ED patients will be enrolled and followed before and after the intervention is delivered to clinicians. Clinicians at one site will receive the intervention and clinicians at control sites will complete outcome collection without receiving the intervention.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of Talk About It (1)
timeFrame: At 18 months
measure: Uptake of Talk About It (2)
timeFrame: At 6-18 months
measure: Uptake of Talk About It (3)
timeFrame: At 6-18 months
measure: Uptake of Talk About It (4)
timeFrame: At 6-18 months
measure: Medications for Opioid Use Disorder (MOUD) initiation
timeFrame: From 0-24 months
measure: Recruitment: Clinician enrollment
timeFrame: From 0-12 months
measure: Recruitment: Patient enrollment
timeFrame: From 0-24 months
measure: Acceptability/Feasibility of Talk About It
timeFrame: At 6 and 18 months
Secondary outcomes:
measure: Knowledge/Awareness
timeFrame: From 0-24 months
measure: Perception of clinicians' compassion
timeFrame: From 0-24 months
measure: Perceived Stigma
timeFrame: From 0-24 months
measure: Attitudes towards methadone
timeFrame: From 0-24 months
measure: Attitudes towards buprenorphine
timeFrame: From 0-24 months
measure: Engagement/SDM
timeFrame: From 0-24 months
measure: Trust
timeFrame: From 0-24 months
measure: Readiness to change
timeFrame: From 0-24 months
measure: Stigma
timeFrame: From 0-24 months
measure: Self-efficacy for conversations about MOUD
timeFrame: From 0-24 months
measure: Adherence to MOUD
timeFrame: From 0-24 months
measure: Illegal opioid use
timeFrame: From 0-24 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
References: