The Emergency Department Longitudinal Integrated Care

NCT05327166 | Active Not Recruiting DMC

• 2 other identifiers: STUDY00012599R01DA051462
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Keywords

collaborative care; opioid use disorder (OUD); substance use disorder

Outcome Measures

Primary Outcomes (3)

• Change in Illicit Opioid Use Over Time

  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.

  Baseline ED visit and 1, 3, 6 and 12-months after ED visit

• Initiation of Medications for OUD

  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.

  12 months

• Change in Emergency Department visits

  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.

  Index Emergency Department visit to 12-months followup

Secondary Outcomes (11)

• 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

Study Arms (2)

Usual Care

NO INTERVENTION

Participants assigned to this arm will receive usual care.

ED-LINC Intervention

EXPERIMENTAL

Patients assigned to the ED-LINC intervention will receive 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 and 5) weekly caseload supervision allowing for stepped-up care targeting opioid use and comorbidity.

Other: ED-LINC

Interventions

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.

Also known as: Collaborative Care

ED-LINC Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lauren K Whiteside, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Emergency Medicine

Model Details: Participants will be randomized to either usual care (n=250) or ED-LINC intervention (n=250). Patients assigned to the ED-LINC intervention will receive 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.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: April 14, 2022
• Study Start: April 12, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

US (1)