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Active, Not Recruiting

NCT Number: NCT05327166

The Emergency Department Longitudinal Integrated Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ED-LINC

Other

The ED-LINC intervention provides 1) overdose education, 2) brief bedside intervention targeting motivation to engage in outpatient care, 3) a patient-centered approach to MOUD using a treatment decision support tool, 4) longitudinal and proactive care management which will proceed for 3 months, and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity.

Other names: Collaborative Care

Primary outcomes

  1. Change in Illicit Opioid Use Over Time

    Time frame: 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.

  2. Initiation of Medications for OUD

    Time frame: 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.

  3. Change in Emergency Department visits

    Time frame: 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.

Secondary outcomes

  1. Intervention effect when associated with Methamphetamine use

    Time frame: Index Emergency Department visit to 12-months followup

    Explore the impact of methamphetamine use, as measured by the timeline follow-back (TLFB) which is a validated patient self-report measure of days of methamphetamine use over a 30 day-period, on intervention treatment effects.

  2. Time to Initiation of MOUD

    Time frame: 12 months

    To compare time to 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.

  3. Engagement in Medications for OUD

    Time frame: 12 months

    To compare the frequency of engagement in medications for opioid use disorder (MOUD) where MOUD includes buprenorphine, methadone and/or naltexone in subjects receiving usual care or ED-LINC 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.

  4. Retention in Medications for OUD

    Time frame: 12 months

    To compare the frequency of retention in 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 visit using statewide data for prescriptions and Medicaid billing data for medication administration augmented with patient self-report MOUD at scheduled follow-up intervals.

  5. Intervention effect when associated depression

    Time frame: Index Emergency Department visit to 12-months followup

    Explore the impact of depression in the past 30-days as measured by self-report PHQ-9 at baseline on intervention treatment effects.

  6. Intervention effect when associated anxiety

    Time frame: Index Emergency Department visit to 12-months followup

    Explore the impact of anxiety in the past 30-days as measured by self-report GAD-7 at baseline on intervention treatment effects.

  7. Intervention effect when associated PTSD

    Time frame: Index Emergency Department visit to 12-months followup

    Explore the impact of PTSD in the past 30-days as measured by self-report PCL-C at baseline on intervention treatment effects.baseline on intervention treatment effects.

  8. Intervention effect when associated current pain

    Time frame: Index Emergency Department visit to 12-months followup

    Explore the impact of pain in the past week as measured by the self-report 3-item PEG at baseline on intervention treatment effects.

  9. Intervention effect when patient has exposure to MOUD in prior 12 months

    Time frame: Index Emergency Department visit to 12-months followup

    Explore the impact of any past 12-month MOUD exposure prior to enrollment where MOUD includes buprenorphine, methadone and/or naltexone assessed from review of medical records, using statewide data for prescriptions and Medicaid billing data for medication administration augmented with patient self-report MOUD obtained at baseline on the intervention treatment effect.

  10. Intervention effect by sex

    Time frame: Index Emergency Department visit to 12-months followup

    Explore the impact of patient sex as measured by patient self-report at baseline on intervention treatment effects

  11. Intervention effect when patient reports using illicit fentanyl at baseline

    Time frame: Index Emergency Department visit to 12-months followup

    Explore the impact of fentanyl use as measured by any patient self-report fentanyl use in the past 30-days at baseline on the intervention treatment effect

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

The Emergency Department Longitudinal Integrated Care Effectiveness Randomized Trial Targeting Opioid Use and Related Comorbidity From the ED

Acronym: ED-LINC2

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2022
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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