Emergency Department Longitudinal Integrated Care

Opioid-use Disorder Clinical Trial

— ED-LINC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699085
• Other study ID #: STUDY00005447
• Secondary ID: K23DA039974
• Status: Completed
• Phase: N/A
• Start date: December 11, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Department
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• ED-LINC
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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Follow up Completion Rates	The number of participants who completed follow-ups at 6 month time point.	6 months
Primary	ED-LINC Intervention and Usual Care Process Outcomes	Number of participants that received at least 1 ED-LINC element	6 months
Primary	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
Primary	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
Primary	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	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.	6 months
Secondary	Health Care Utilization	Emergency department (ED) utilization will be assessed using the Emergency Department Information Exchange (EDIE) .	6 months