Emergency Department Longitudinal Integrated Care

NCT03699085 | Completed Results

• 2 other identifiers: STUDY00005447K23DA039974
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder; Emergency Department

Keywords

Opioid Use; Emergency Department; Collaborative Care

Outcome Measures

Primary Outcomes (6)

• Refusal Rate

  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

  Baseline

• Follow up Completion Rates

  The number of participants who completed follow-ups at 6 month time point.

  6 months

• ED-LINC Intervention and Usual Care Process Outcomes

  Number of participants that received at least 1 ED-LINC element

  6 months

• Implementation Appropriateness

  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"

  6 months

• ED-LINC Satisfaction

  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)

  6 months

• Perception of Care Coordination

  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.

  6 months

Secondary Outcomes (2)

• Substance Use

  6 months

• Health Care Utilization

  6 months

Study Arms (2)

ED-LINC Intervention Condition

EXPERIMENTAL

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.

Behavioral: ED-LINC

Usual Care Condition

NO INTERVENTION

Patients in this arm may receive a spectrum of consulting services visits including social work services, psychiatric consultation, inpatient psychiatry consult, rehabilitation psychology consultation, addiction intervention services, pain team consultation services that include MD psychiatric and PhD psychologist providers, spiritual care or other consulting services which shall count as usual care.

Interventions

ED-LINC BEHAVIORAL

ED-LINC will include 1) A brief negotiated interview at the bedside with an emphasis on motivation to link to services 2) Pharmacotherapy including a discussion of opioid safety, take-home naloxone and initiation of buprenorphine from the ED for participants that are interested and eligible; 3) Longitudinal care management which will proceed for 3-months; and 4) Care plan in the Emergency Department Information Exchange (EDIE) system. This will be coupled with a study cell phone and a weekly supervisory case conference which is consistent with collaborative care principles.

ED-LINC Intervention Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Whiteside LK, Huynh L, Morse S, Hall J, Meurer W, Banta-Green CJ, Scheuer H, Cunningham R, McGovern M, Zatzick DF. The Emergency Department Longitudinal Integrated Care (ED-LINC) intervention targeting opioid use disorder: A pilot randomized clinical trial. J Subst Abuse Treat. 2022 May;136:108666. doi: 10.1016/j.jsat.2021.108666. Epub 2021 Nov 24.

  PMID: 34952745 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Emergencies

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lauren Whiteside, Primary Investigator
• Organization: University of Washington

laurenkw@uw.edu

206-744-8464

Study Officials

• Lauren Whiteside, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals on the study team designated to conduct follow up interviews will be blinded to which arm participants belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Department of Emergency Medicine

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: December 11, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)