Emergency Department Longitudinal Integrated Care

Overview

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.

Full Title of Study: “A Longitudinal Collaborative Care Model for Patients With Opioid Problems: Emergency Department Longitudinal Integrated Care (ED-LINC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

Detailed Description

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.

Interventions

  • Behavioral: ED-LINC
    • ED-LINC will include 1) A brief negotiated interview at the bedside with an emphasis on motivation to link to services 2) Pharmacotherapy including a discussion of opioid safety, take-home naloxone and initiation of buprenorphine from the ED for participants that are interested and eligible; 3) Longitudinal care management which will proceed for 3-months; and 4) Care plan in the Emergency Department Information Exchange (EDIE) system. This will be coupled with a study cell phone and a weekly supervisory case conference which is consistent with collaborative care principles.

Arms, Groups and Cohorts

  • Experimental: ED-LINC Intervention Condition
    • Patients in this arm will receive the ED-LINC intervention. Elements of ED-LINC are based on evidence-based treatments and are central components of collaborative care. ED-LINC will be supported by a novel Emergency Department Information Exchange (EDIE) technology platform that allows for the creation of ED care plans and electronic alerts and will assist in care coordination of this complex population.
  • No Intervention: Usual Care Condition
    • Patients in this arm may receive a spectrum of consulting services visits including social work services, psychiatric consultation, inpatient psychiatry consult, rehabilitation psychology consultation, addiction intervention services, pain team consultation services that include MD psychiatric and PhD psychologist providers, spiritual care or other consulting services which shall count as usual care.

Clinical Trial Outcome Measures

Primary Measures

  • Enrollment Rates
    • Time Frame: Baseline
    • To determine enrollment rates (patients enrolled/patients eligible), consent rates (consent obtained/patients approached)
  • Follow up completion rates
    • Time Frame: 6 months
    • To determine follow-up completion rates we will calculate the number of possible follow-ups/number of actual completed followups at each follow-up time point.
  • ED-LINC Intervention and Usual Care Process Outcomes
    • Time Frame: 6 months
    • Calculated by the number of elements of ED-LINC received by each participant, intervention completion rates and number and types of contacts made by the interventionist.
  • Implementation Appropriateness
    • Time Frame: 6 months
    • The Intervention Appropriateness Measure (IAM) (0-20) will be used to assess appropriateness of the intervention for all participants randomized to ED-LINC
  • ED-LINC satisfaction
    • Time Frame: 6 months
    • Client Satisfaction Questionnaire (CSQ-8) questions (8-32) will be used to assess satisfaction with ED-LINC
  • Perception of Care Coordination
    • Time Frame: 6 months
    • The Patient Assessment of Chronic Illness Care – Coordination (PACIC-C) (0-25) questions will be asked of all participants

Secondary Measures

  • Substance Use
    • Time Frame: 6 months
    • substance use will be measured utilizing a time-line follow back calendar administered by the research assistant to determine days of heroin or illicit opioid use and days of prescription opioid misuse.
  • Health Care Utilization
    • Time Frame: 6 months
    • Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) . Participants will provide self-report information on primary care visits, mental health and substance use treatment visits.

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lauren Whiteside, Assistant Professor, School of Medicine: Department of Emergency Medicine – University of Washington
  • Overall Official(s)
    • Lauren Whiteside, MD, Principal Investigator, University of Washington

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