Emergency Department Longitudinal Integrated Care

Not Applicable

Completed

• Conditions: Emergency Department; Opioid-use Disorder
• Interventions: Behavioral: ED-LINC

• Registration Number: NCT03699085
• Lead Sponsor: University of Washington

Brief Summary

The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. This study will provide important feasibility information for future studies of ED-LINC. The collaborative care intervention (ED-LINC) will be supported by a novel Emergency Departement (ED) health information exchange platform.

Detailed Description

The overarching goal of this investigation is to develop and determine the feasibility of a multi-component intervention adapted from a collaborative care framework initiated in the ED for patients at risk for opioid use disorder. According to the 2015 national survey on drug use and health, an estimated 3.8 million individuals over 12 years of age were currently misusing opioid pain relievers. An additional 329,000 people use heroin. The Emergency Department (ED) is currently at the forefront of this public health emergency and often a place where patients come for treatment of overdose and for treatment of medical problems related to illicit opioid use.

Overall, the goal is to establish the feasibility of a multi-component intervention called 'Emergency Department Longitudinal Integrated Care (ED-LINC)' which is guided by principles of collaborative care and is comprised of components that are evidence-based. ED-LINC is initiated from the ED and continues longitudinally for patients at-risk for opioid use disorder.

Study Timeline

• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-09
• Study Start: 2018-12-11
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Results First Submitted: 2022-10-10
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Results First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged 18-65
• Patients with at least one risk factor for opioid use disorder via the EMR pre-screen
• Patients with score of ≥ 4 on the NIDA modified ASSIST for illicit opioids (e.g. heroin) OR a score of ≥ 4 on the NIDA modified ASSIST for prescription opioids
• Currently have a phone
• Able to provide a phone number and one additional piece of contact information

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Exclusion Criteria

• They are incarcerated or under arrest
• Non-English speaking
• Live beyond a 50 mile radius of HMC
• Require active resuscitation in the ED or other clinical area at the time of 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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ED-LINC Intervention Condition	ED-LINC	Patients in this arm will receive the ED-LINC intervention. Elements of ED-LINC are based on evidence-based treatments and are central components of collaborative care. ED-LINC will be supported by a novel Emergency Department Information Exchange (EDIE) technology platform that allows for the creation of ED care plans and electronic alerts and will assist in care coordination of this complex population.

Primary Outcome Measures

Name	Time	Method
ED-LINC Intervention and Usual Care Process Outcomes	6 months	Number of participants that received at least 1 ED-LINC element
Follow up Completion Rates	6 months	The number of participants who completed follow-ups at 6 month time point.
Implementation Appropriateness	6 months	Participants randomized to ED-LINC care were asked about the appropriateness of interventional activities.by rating the agreeability of the statement "ED LINC seemed fitting and suitable"
Refusal Rate	Baseline	Percentage of subjects who agree to participate in screening survey prior to determining eligibility status. Potential subjects identified by suspected risky substance use history based on EMR review
ED-LINC Satisfaction	6 months	Client Satisfaction Questionnaire (CSQ-8) questions (8-32) will be used to assess satisfaction with ED-LINC, in which greater numbers designate higher satisfaction (32 is maximum or highest satisfaction rating possible)
Perception of Care Coordination	6 months	The Patient Assessment of Chronic Illness Care - Coordination (PACIC-C) questions will be asked of all participants, where greater numbers indicate perception was more coordinated (greater number is better). For the scale, scores must be discrete numbers, with a minimum possible value of 5 and maximum possible value of 25.

Secondary Outcome Measures

Name	Time	Method
Substance Use	6 months	Comparison between control population and intervention population based on substance use measured utilizing a time-line follow back (TLFB) calendar administered by the research assistant to for past 30-day heroin use at TLFB timepoints (Baseline, 1 month, 3 months, 6 months). Table shows the average of unadjusted TLFB days of Heroin Use with 95% Confidence Interval.
Health Care Utilization	6 months	Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) .

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States