Aim 2 - Conversations Can Save Lives: TALKing About Buprenorphine & Methadone for Opioid Use Treatment Initiation (TALK ABOUT It)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Uptake of Talk About It (1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will receive usual care in all encounters.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •No Opioid Use Disorder (OUD)
- •already on MOUD
结局指标
主要结局
Uptake of Talk About It (1)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: At 6-18 months
Number of times patient reports using Talk About It on follow-up survey
Medications for Opioid Use Disorder (MOUD) initiation
时间窗: 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
时间窗: From 0-12 months
Average number of eligible clinicians who complete training and survey instruments
Recruitment: Patient enrollment
时间窗: From 0-24 months
Average number of eligible patients who are enrolled each month
Acceptability/Feasibility of Talk About It
时间窗: 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
次要结局
- Perception of clinicians' compassion(From 0-24 months)
- Attitudes towards buprenorphine(From 0-24 months)
- Knowledge/Awareness(From 0-24 months)
- Adherence to MOUD(From 0-24 months)
- Perceived Stigma(From 0-24 months)
- Engagement/SDM(From 0-24 months)
- Readiness to change(From 0-24 months)
- Illegal opioid use(From 0-24 months)
- Attitudes towards methadone(From 0-24 months)
- Trust(From 0-24 months)
- Stigma(From 0-24 months)
- Self-efficacy for conversations about MOUD(From 0-24 months)
研究者
Elizabeth Schoenfeld, MD
Vice Chair of Research, Department of Emergency Medicine
Baystate Medical Center