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Emergency Department Longitudinal Integrated Care (ED-LINC)

Primary Purpose

Opioid-use Disorder, Emergency Department

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ED-LINC
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring Opioid Use, Emergency Department, Collaborative Care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ED-LINC Intervention Condition

Usual Care Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Follow up Completion Rates
The number of participants who completed follow-ups at 6 month time point.
ED-LINC Intervention and Usual Care Process Outcomes
Number of participants that received at least 1 ED-LINC element
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"
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)
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2018
Last Updated
May 25, 2023
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03699085
Brief Title
Emergency Department Longitudinal Integrated Care
Acronym
ED-LINC
Official Title
A Longitudinal Collaborative Care Model for Patients With Opioid Problems: Emergency Department Longitudinal Integrated Care (ED-LINC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Emergency Department
Keywords
Opioid Use, Emergency Department, Collaborative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Individuals on the study team designated to conduct follow up interviews will be blinded to which arm participants belong to.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ED-LINC Intervention Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Condition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ED-LINC
Intervention Description
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 Outcome Measure Information:
Title
Refusal Rate
Description
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
Time Frame
Baseline
Title
Follow up Completion Rates
Description
The number of participants who completed follow-ups at 6 month time point.
Time Frame
6 months
Title
ED-LINC Intervention and Usual Care Process Outcomes
Description
Number of participants that received at least 1 ED-LINC element
Time Frame
6 months
Title
Implementation Appropriateness
Description
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"
Time Frame
6 months
Title
ED-LINC Satisfaction
Description
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)
Time Frame
6 months
Title
Perception of Care Coordination
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Substance Use
Description
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.
Time Frame
6 months
Title
Health Care Utilization
Description
Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) .
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Whiteside, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34952745
Citation
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.
Results Reference
derived

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Emergency Department Longitudinal Integrated Care

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