ED-LINC for Opioid Use Disorder

(ED-LINC2 Trial)

Overseen By Layla A Anderson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Chronic opioids

Disqualifiers: Incarcerated, Non-English, Palliative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are receiving chronic opioid therapy, you are not eligible to participate.

What data supports the effectiveness of the ED-LINC treatment for opioid use disorder?

The ED-LINC treatment, which involves collaborative care from the emergency department, has been shown to be feasible and acceptable for patients with prescription drug misuse, including opioids. Although there was no significant change in prescription drug misuse over time, a majority of patients reported receiving high-quality, desired intervention services, indicating potential benefits in patient satisfaction and care coordination. ^{1 2 3 4 5}

Is the ED-LINC treatment generally safe for humans?

The ED-LINC treatment, which involves coordinated care and medication safety for patients with prescription drug misuse, was found to be feasible and acceptable to patients in a study. Most participants reported receiving high-quality care, and there were no significant safety concerns reported during the study. ^{1 2 3 5 6}

How is the ED-LINC treatment for opioid use disorder different from other treatments?

ED-LINC is unique because it starts in the emergency department and provides ongoing care coordination, medication safety, and use of electronic medical records to manage opioid use disorder over six months, unlike traditional treatments that often end after the initial ED visit. ^{1 2 7 8 9}

Research Team

Lauren K Whiteside, MD, MS

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adults over 18 with moderate or severe opioid use disorder (OUD) who have a phone and can provide contact information. It's not for those in other care programs, incarcerated individuals, non-English speakers, people living far from Harborview Medical Center, or patients needing urgent psychiatric help.

Inclusion Criteria

I can provide a phone number and another way to contact me.

Moderate or Severe OUD based on the Structured Clinical Interview for DSM Disorders (SCID)

I am 18 years old or older.

Exclusion Criteria

Require active resuscitation in the ED or other clinical area at the time of Research Assistant (RA) approach

I do not speak English.

I am in the hospital for a mental health crisis needing urgent psychiatric evaluation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ED-LINC intervention, including overdose education, motivational bedside intervention, and a patient-centered approach to MOUD, with longitudinal care management for approximately 3 months

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, 6, and 12 months

12 months

4 visits (in-person or virtual)

Treatment Details

Interventions

• ED-LINC

Trial Overview The study tests 'Emergency Department Longitudinal Integrated Care' (ED-LINC), which aims to improve outcomes for OUD patients. It compares ED-LINC's effectiveness against usual care in reducing illicit opioid use, increasing treatment retention, and decreasing emergency department visits.

Participant Groups

Group I: ED-LINC Intervention Experimental Treatment 1 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 II: Usual Care Active Control 1 Intervention

Participants assigned to this arm will receive usual care.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Initiating opioid use disorder (OUD) treatment in the emergency department (ED) significantly increases patient engagement in outpatient addiction care, with a 2.30 times higher likelihood of follow-up treatment for those who received ED-OUD care.

However, there were disparities in referrals, with Black and Hispanic/Latinx patients receiving fewer referrals than expected, highlighting a need for improved equity in access to OUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency Department-initiated Buprenorphine and Referral to Follow-up Addiction Care: A Program Description. Regan, S., Howard, S., Powell, E., et al.[2023]

The pilot study involving 30 injured patients with prescription drug misuse showed that a Collaborative Care intervention initiated from the Emergency Department is feasible and well-accepted, with over 80% of participants reporting high-quality services.

Despite the comprehensive care management approach, which included active coordination and linkage to primary care, there was no significant change in prescription drug misuse over the six-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care from the emergency department for injured patients with prescription drug misuse: An open feasibility study. Whiteside, LK., Darnell, D., Jackson, K., et al.[2018]

In 2017, there were an estimated 1,507,550 emergency department visits related to opioid use disorder (OUD), with overdoses accounting for nearly 20% of these visits, highlighting the critical need for effective interventions in emergency settings.

Emergency departments with the highest rates of OUD visits (22.9 per 1000 visits) were predominantly located in metropolitan areas and included a significant number of teaching hospitals, suggesting that targeting these facilities for OUD treatment programs could enhance care for a large population of affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in emergency department visit rates for opioid use disorder: Implications for quality improvement initiatives. Khatri, UG., Samuels, EA., Xiong, R., et al.[2021]

In a study of 1339 opioid-related visits across three urban emergency departments, only 23% of patients received medications for opioid use disorder (MOUDs), with treatment rates varying significantly by clinical presentation: 6% for overdose cases and 69% for withdrawal cases.

Focus group discussions with 28 ED clinicians revealed that successful initiation of OUD treatment depends on factors like patient receptivity and provider confidence, indicating a need for tailored clinical guidance to improve treatment practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in opioid use disorder clinical presentations and treatment in the emergency department: A mixed-methods study. Faude, S., Delgado, MK., Perrone, J., et al.[2023]

Emergency departments (EDs) have successfully implemented buprenorphine programs for treating opioid use disorder at four diverse urban academic medical centers, highlighting the effectiveness of tailored approaches in different settings.

Key factors for successful implementation included strong hospital support, integration with electronic medical records, and collaboration with outpatient services, which helped overcome barriers to providing timely treatment for patients with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models for Implementing Emergency Department-Initiated Buprenorphine With Referral for Ongoing Medication Treatment at Emergency Department Discharge in Diverse Academic Centers. Whiteside, LK., D'Onofrio, G., Fiellin, DA., et al.[2023]

Out of 394 emergency department patients with untreated moderate to severe opioid use disorder, only 15.2% were actively seeking a referral to substance use treatment, indicating a significant gap in treatment engagement.

Patients seeking treatment referrals were less likely to test positive for amphetamines and methamphetamines, suggesting that those with fewer concurrent substance use issues may be more inclined to seek help for their opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department patients with untreated opioid use disorder: A comparison of those seeking versus not seeking referral to substance use treatment. Coupet, E., D'Onofrio, G., Chawarski, M., et al.[2022]

Emergency department-based peer support programs are effective in connecting individuals with opioid use disorder (OUD) to medication and recovery services, showing promise in addressing the opioid crisis.

The integration of peer support varies across programs, affecting how peers are alerted to potential patients and how they engage with them, highlighting the need for consistent reporting on these methods in future evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department-based peer support for opioid use disorder: Emergent functions and forms. McGuire, AB., Powell, KG., Treitler, PC., et al.[2021]

The study identified five distinct models of integrated care for families affected by opioid use disorder (OUD), emphasizing the need for supportive and frequent visits with various providers, although billing constraints hinder full integration of services.

Key components for effective dyadic care include prioritizing care coordination, overcoming barriers to integrate medical and behavioral services, and ensuring child safety while maintaining parental trust, highlighting the complexities of addressing both parental and infant health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs. Schiff, DM., Partridge, S., Gummadi, NH., et al.[2023]

The study emphasizes the need to transform emergency department (ED) care for patients with opioid use disorder (OUD) by initiating lifesaving treatment during the ED visit, rather than discharging them without support.

A nurse-driven protocol was developed that includes OUD screening at triage and automated prompts for healthcare providers, ensuring timely assessment and treatment, which could improve patient outcomes and streamline care pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redesign of Opioid Use Disorder Screening and Treatment in the ED. Lowenstein, M., McFadden, R., Abdel-Rahman, D., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Emergency Department-initiated Buprenorphine and Referral to Follow-up Addiction Care: A Program Description. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Collaborative care from the emergency department for injured patients with prescription drug misuse: An open feasibility study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Variation in emergency department visit rates for opioid use disorder: Implications for quality improvement initiatives. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Variability in opioid use disorder clinical presentations and treatment in the emergency department: A mixed-methods study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Models for Implementing Emergency Department-Initiated Buprenorphine With Referral for Ongoing Medication Treatment at Emergency Department Discharge in Diverse Academic Centers. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Emergency department patients with untreated opioid use disorder: A comparison of those seeking versus not seeking referral to substance use treatment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Emergency department-based peer support for opioid use disorder: Emergent functions and forms. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Redesign of Opioid Use Disorder Screening and Treatment in the ED. [2023]