The Emergency Department Longitudinal Integrated Care

NCT ID: NCT05327166

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2026-12-31

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.

Detailed Description

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.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

Participants assigned to this arm will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ED-LINC Intervention

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.

Group Type: EXPERIMENTAL

ED-LINC

Intervention Type: 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.

Interventions

ED-LINC

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.

Intervention Type: OTHER

Other Intervention Names

Collaborative Care

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Lauren Whiteside

Assistant Professor, Department of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren K Whiteside, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

R01DA051462

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00012599

Identifier Type: -

Identifier Source: org_study_id