Emergency Department Initiated Oral Naltrexone for Patients With Moderate to Severe Alcohol Use Disorder: A Pilot Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14
研究概览
简要总结
This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in comprehensive addiction treatment at 14 and 30 days post enrollment.
详细描述
Overview
The study will be comprised of two components outlined below:
- Site Implementation Component
In this component implementation science strategies will be used to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability and linkage pathways. Three specific aims are to, 1) optimize registered nurse (RN) driven non-targeted alcohol use screening supplemented with secondary screening using DSM-5 criteria for AUD and an SBIRT (screening, brief intervention and referral to treatment) intervention administered by trained staff. 2) During a 3-month period, use continuous quality improvement methods to decrease the time for completion of AUD screening to an interval that is acceptable to ED patients and ED providers and 3) Assess willingness to initiate oral naltrexone among ED patients with moderate to severe AUD. Ten (10) patients will be enrolled in phase 1. 2. Oral Naltrexone Feasibility Component
In this component the study team aims to assess the feasibility of initiating treatment in ED patients with moderate to severe AUD on oral naltrexone, an evidence based and accepted standard of care treatment for AUD. Specifically, 1) over an 8-month period the study team aims to identify 20 patients with moderate to severe AUD eligible and interested in immediate initiation of oral naltrexone. Consenting patients will be receive a standard SBIRT intervention and be provided with immediate oral naltrexone initiation in the ED with a 14-day starter pack at the time of ED discharge. All participants will receive facilitated linkage to comprehensive out-patient care. 2) The study team aims will evaluate the impact of immediate ED initiated oral naltrexone with the primary outcome being engagement in comprehensive addiction care at 14 and 30 days post enrollment. Secondary outcomes include medication adherence, changes in daily alcohol consumption, number of heavy drinking days, hospital admissions and ED utilization, transition to long-acting injectable naltrexone and alcohol craving. 3) Lastly, the study team will collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive randomized controlled trial of ED-initiated oral naltrexone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Emergency Department patients 18 years of age or older
- •Treated in the ED during screening hours
- •Moderate to severe AUD as determined by DSM-5 criteria
- •Able to speak and understand English
- •Medically stable for an interview as determined by their primary ED provider
- •Willing and able to consent to study participation
- •Two points of contact available for follow-up
排除标准
- •ED patients younger than 18 years of age
- •Medically or psychiatrically unstable as determined by the ED provider
- •Unable to speak or understand English
- •Unable to provide consent for study participation
- •Past year opioid dependence
- •Urine drug screen positive for opioids
- •Current or anticipated need for opioid medications for pain
- •Anticipated surgical procedure within 14-day of ED visit
- •Serologic evidence of liver disease (LFTs 3X normal) within 7 days of enrollment
- •Cirrhosis either by PMH or self-report
- •Pregnant or breastfeeding
- •Lacking contact information for follow-up
- •Requiring in-patient admission for medical or psychiatric reasons
- •Patient receiving a sexual assault forensics exam (SAFE)
- •Patient suspected of having COVID-19
- •Patient is actively suicidal or homicidal
- •Previously enrolled in either the implementation or feasibility phase of the study
- •Be a prisoner or in police custody at the time of the index ED visit
- •Be currently (anytime within the last 14 days) enrolled in formal addiction treatment, including by court order.
研究组 & 干预措施
Oral Naloxone
Oral Naltrexone initiation
干预措施: Emergency Department Initiated Oral Naltrexone (Drug)
结局指标
主要结局
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14
时间窗: Day 14
Number of participant enrolled with engagement in care of comprehensive addiction treatment
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30
时间窗: Day 30
Number of participant enrolled with engagement in care of comprehensive addiction treatment
次要结局
- Number of Alcoholic Drinks Per Day(7-days prior to enrollment to day of enrollment (baseline))
- Number of Daily Drinks(30-days)
- Daily Alcohol Craving Scale(up to 30 days)
- Guidelines Regimen Information Program (GRIP) Guide at Day 14(Day 14)
- Guidelines Regimen Information Program (GRIP) Guide at Day 30(Day 30)
- Number of Pills in Bottle at Day 14(Day 14)
- Number of Pills in Bottle at Day 30(Day 30)
- Number of Heavy Drinking Days(up to 30 days)
- Health Services Utilization Survey(up to 30-days)
- Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL)(Day 30)
- The Patient Rated Inventory of Side Effects (PRISE) Survey(Day 30)
- AUD Program Satisfaction Survey at Baseline(Baseline)
- Number of Participants Who Transition to LA Injectable(Day 30)
研究者
Ethan Cowan
Professor of Emergency Medicine
Icahn School of Medicine at Mount Sinai