The Emergency Department Longitudinal Integrated Care

Opioid Use Disorder Clinical Trial

— ED-LINC2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327166
• Other study ID #: STUDY00012599
• Secondary ID: R01DA051462
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2022
• Source: University of Washington
• Contact: Layla A Anderson
• Phone: 206-744-2556
• Email: anderla[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Intervention effect when associated with Methamphetamine use	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.	Index Emergency Department visit to 12-months followup
Secondary	Time to Initiation of MOUD	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.	12 months
Secondary	Engagement in Medications for OUD	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.	12 months
Secondary	Retention in Medications for OUD	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.	12 months
Secondary	Intervention effect when associated depression	Explore the impact of depression in the past 30-days as measured by self-report PHQ-9 at baseline on intervention treatment effects.	Index Emergency Department visit to 12-months followup
Secondary	Intervention effect when associated anxiety	Explore the impact of anxiety in the past 30-days as measured by self-report GAD-7 at baseline on intervention treatment effects.	Index Emergency Department visit to 12-months followup
Secondary	Intervention effect when associated PTSD	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.	Index Emergency Department visit to 12-months followup
Secondary	Intervention effect when associated current pain	Explore the impact of pain in the past week as measured by the self-report 3-item PEG at baseline on intervention treatment effects.	Index Emergency Department visit to 12-months followup
Secondary	Intervention effect when patient has exposure to MOUD in prior 12 months	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.	Index Emergency Department visit to 12-months followup
Secondary	Intervention effect by sex	Explore the impact of patient sex as measured by patient self-report at baseline on intervention treatment effects	Index Emergency Department visit to 12-months followup
Secondary	Intervention effect when patient reports using illicit fentanyl at baseline	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	Index Emergency Department visit to 12-months followup