The Emergency Department Longitudinal Integrated Care Effectiveness Randomized Trial Targeting Opioid Use and Related Comorbidity From the ED
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Initiation of Medications for OUD
研究概览
简要总结
Collaborative care is a comprehensive patient-centered model of healthcare delivery targeting behavioral health or substance use that stems from the chronic disease management framework. The intervention being tested ('Emergency Department Longitudinal Integrated Care' or ED LINC) derives from the collaborative care model and has demonstrated feasibility in previous studies.
This study expands on the model to test the effectiveness of the ED-LINC intervention when compared with usual care. The study team primarily hypothesizes that patients randomized to the ED-LINC intervention, when compared to patients randomized to usual care, will demonstrate: 1) significant reductions in self-report illicit opioid use, 2) significant increases in initiation and retention of medications for opioid use disorder, and 3) significant reductions in ED utilization.
详细描述
This is a randomized clinical trial designed to test the effectiveness of the multi-component ED-LINC intervention. Patients with moderate or severe OUD seeking medical care at 2 EDs in Seattle, Washington, who provide informed consent will be randomized to the ED-LINC intervention (n=250) or usual care control (n=250) conditions.
ED-LINC will include: 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to medications for opioid use disorder (MOUD) using a treatment decision support tool, 4) longitudinal and proactive care management which will proceed for approximately 3 months, and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity. This intervention will use the Emergency Department Information Exchange (EDIE) to re-engage patients with subsequent ED visits.
This study team developed the 'Emergency Department Longitudinal Integrated Care 2.0' intervention or 'ED-LINC' for patients with OUD to be initiated from the ED. In prior work, ED-LINC was feasible and retention in the study was high in both an intervention arm and a usual care control arm. Additionally, participants randomized to the ED-LINC arm were satisfied and acceptability of the intervention was high. Elements of ED-LINC are based on evidence-based treatments and are central components of collaborative care and will acknowledge the longitudinal care required for opioid use disorder and related substance abuse, mental health and medical comorbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the intervention, this is an open label study since participants will know whether they are receiving ED-LINC resources or usual care.
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
- •Aged 18 years or older
- •Moderate or Severe OUD based on the Structured Clinical Interview for DSM Disorders (SCID)
- •Currently have a phone or method of contact
- •Able to provide a phone number and one additional piece of contact information
排除标准
- •Incarcerated or under arrest
- •Non-English speaking
- •Live beyond a 50 mile radius of Harborview Medical Center
- •Require active resuscitation in the ED or other clinical area at the time of Research Assistant (RA) approach
- •Are receiving palliative care services or hospice care for a chronic illness such as metastatic cancer
- •Are in the ED or hospital for a primary psychiatric emergency such as suicidal ideation or attempt and require emergent evaluation by a Psychiatrist
- •Receiving chronic opioid therapy (COT) defined as prescription opioids for most days out of the last 90 days for a chronic pain condition
- •In the ED for sexual assault
- •Enrolled or eligible for state-funded or hospital-funded care coordination program based on high utilization of the ED
结局指标
主要结局
Initiation of Medications for OUD
时间窗: 12 months
To compare the frequency of initiation of medications for opioid use disorder (MOUD) where MOUD includes buprenorphine, methadone and/or naltexone in subjects receiving usual care or ED-LINC intervention over the course of the year after the index Emergency Department visit using statewide data for prescriptions and Medicaid billing data for medication administration augmented with patient self-report MOUD at scheduled follow-up intervals.
Change in Emergency Department visits
时间窗: Index Emergency Department visit to 12-months followup
To compare changes over time in Emergency Department visits in subjects receiving usual care or ED-LINC intervention; Emergency Department visits will be measured by the Emergency Department Information Exchange (an automated health information exchange) that caputures population-level Emergency Department utilization for all enrolled participants.
Change in Illicit Opioid Use Over Time
时间窗: Baseline ED visit and 1, 3, 6 and 12-months after ED visit
To compare self-reported past-30 day illicit opioid use using the validated self-report measure of timeline followback (TLFB) in subjects receiving usual care or ED-LINC intervention over the course of the year after the index Emergency Department visit.
次要结局
- Intervention effect when associated with Methamphetamine use(Index Emergency Department visit to 12-months followup)
- Time to Initiation of MOUD(12 months)
- Engagement in Medications for OUD(12 months)
- Retention in Medications for OUD(12 months)
- Intervention effect when associated depression(Index Emergency Department visit to 12-months followup)
- Intervention effect when associated anxiety(Index Emergency Department visit to 12-months followup)
- Intervention effect when associated PTSD(Index Emergency Department visit to 12-months followup)
- Intervention effect when patient has exposure to MOUD in prior 12 months(Index Emergency Department visit to 12-months followup)
- Intervention effect when associated current pain(Index Emergency Department visit to 12-months followup)
- Intervention effect by sex(Index Emergency Department visit to 12-months followup)
- Intervention effect when patient reports using illicit fentanyl at baseline(Index Emergency Department visit to 12-months followup)
研究者
Lauren Whiteside
Assistant Professor, Department of Emergency Medicine
University of Washington