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Completed

NCT Number: NCT03699085

Emergency Department Longitudinal Integrated Care

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Disease Attributes Emergencies Emergency Department Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Primary outcomes

  1. Refusal Rate

    Time frame: 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

  2. Follow up Completion Rates

    Time frame: 6 months

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

  3. ED-LINC Intervention and Usual Care Process Outcomes

    Time frame: 6 months

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

  4. Implementation Appropriateness

    Time frame: 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"

  5. ED-LINC Satisfaction

    Time frame: 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)

  6. Perception of Care Coordination

    Time frame: 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 outcomes

  1. Substance Use

    Time frame: 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.

  2. Health Care Utilization

    Time frame: 6 months

    Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) .

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Longitudinal Collaborative Care Model for Patients With Opioid Problems: Emergency Department Longitudinal Integrated Care (ED-LINC)

Acronym: ED-LINC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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