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临床试验/NCT03699085
NCT03699085已完成不适用

A Longitudinal Collaborative Care Model for Patients With Opioid Problems: Emergency Department Longitudinal Integrated Care (ED-LINC)

University of Washington2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Follow up Completion Rates

研究概览

简要总结

The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. This study will provide important feasibility information for future studies of ED-LINC. The collaborative care intervention (ED-LINC) will be supported by a novel Emergency Departement (ED) health information exchange platform.

详细描述

The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. According to the 2015 national survey on drug use and health, an estimated 3.8 million individuals over 12 years of age were currently misusing opioid pain relievers. An additional 329,000 people use heroin. The Emergency Department (ED) is currently at the forefront of this public health emergency and often a place where patients come for treatment of overdose and for treatment of medical problems related to illicit opioid use.

Overall, the goal is to establish the feasibility of a multi-component intervention called 'Emergency Department Longitudinal Integrated Care (ED-LINC)' which is guided by principles of collaborative care and is comprised of components that are evidence-based. ED-LINC is initiated from the ED and continues longitudinally for patients at-risk for opioid use disorder.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Individuals on the study team designated to conduct follow up interviews will be blinded to which arm participants belong to.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-65
  • Patients with at least one risk factor for opioid use disorder via the EMR pre-screen
  • Patients with score of ≥ 4 on the NIDA modified ASSIST for illicit opioids (e.g. heroin) OR a score of ≥ 4 on the NIDA modified ASSIST for prescription opioids
  • Currently have a phone
  • Able to provide a phone number and one additional piece of contact information

排除标准

  • They are incarcerated or under arrest
  • Non-English speaking
  • Live beyond a 50 mile radius of HMC
  • Require active resuscitation in the ED or other clinical area at the time of 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
  • 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

结局指标

主要结局

Follow up Completion Rates

时间窗: 6 months

The number of participants who completed follow-ups at 6 month time point.

ED-LINC Intervention and Usual Care Process Outcomes

时间窗: 6 months

Number of participants that received at least 1 ED-LINC element

Implementation Appropriateness

时间窗: 6 months

Participants randomized to ED-LINC care were asked about the appropriateness of interventional activities.by rating the agreeability of the statement "ED LINC seemed fitting and suitable"

Refusal Rate

时间窗: Baseline

Percentage of subjects who agree to participate in screening survey prior to determining eligibility status. Potential subjects identified by suspected risky substance use history based on EMR review

ED-LINC Satisfaction

时间窗: 6 months

Client Satisfaction Questionnaire (CSQ-8) questions (8-32) will be used to assess satisfaction with ED-LINC, in which greater numbers designate higher satisfaction (32 is maximum or highest satisfaction rating possible)

Perception of Care Coordination

时间窗: 6 months

The Patient Assessment of Chronic Illness Care - Coordination (PACIC-C) questions will be asked of all participants, where greater numbers indicate perception was more coordinated (greater number is better). For the scale, scores must be discrete numbers, with a minimum possible value of 5 and maximum possible value of 25.

次要结局

  • Substance Use(6 months)
  • Health Care Utilization(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren Whiteside

Assistant Professor, School of Medicine: Department of Emergency Medicine

University of Washington

研究点 (2)

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