Clinical trial NCT05327166: The Emergency Department Longitudinal Integrated Care
Official title: The Emergency Department Longitudinal Integrated Care Effectiveness Randomized Trial Targeting Opioid Use and Related Comorbidity From the ED
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: collaborative care
opioid use disorder (OUD)
substance use disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-04-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Illicit Opioid Use Over Time
timeFrame: Baseline ED visit and 1, 3, 6 and 12-months after ED visit
measure: Initiation of Medications for OUD
timeFrame: 12 months
measure: Change in Emergency Department visits
timeFrame: Index Emergency Department visit to 12-months followup
Secondary outcomes:
measure: Intervention effect when associated with Methamphetamine use
timeFrame: Index Emergency Department visit to 12-months followup
measure: Time to Initiation of MOUD
timeFrame: 12 months
measure: Engagement in Medications for OUD
timeFrame: 12 months
measure: Retention in Medications for OUD
timeFrame: 12 months
measure: Intervention effect when associated depression
timeFrame: Index Emergency Department visit to 12-months followup
measure: Intervention effect when associated anxiety
timeFrame: Index Emergency Department visit to 12-months followup
measure: Intervention effect when associated PTSD
timeFrame: Index Emergency Department visit to 12-months followup
measure: Intervention effect when associated current pain
timeFrame: Index Emergency Department visit to 12-months followup
measure: Intervention effect when patient has exposure to MOUD in prior 12 months
timeFrame: Index Emergency Department visit to 12-months followup
measure: Intervention effect by sex
timeFrame: Index Emergency Department visit to 12-months followup
measure: Intervention effect when patient reports using illicit fentanyl at baseline
timeFrame: Index Emergency Department visit to 12-months followup
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Lauren K Whiteside, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: